Crohn's Disease ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 2139 |
96. クローン病
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03747718 (ClinicalTrials.gov) | December 1, 2022 | 8/3/2018 | Randomized Trial Comparing Single vs. Maintenance Fecal Microbiota Transplant for Refractory Crohn's Disease in Children | A Study for Evaluation of Clinical Response to Single vs. Maintenance Fecal Microbiota Transplantation in Pediatric Patients With Refractory Crohn's Disease | Crohn Disease | Biological: Fecal Microbiota Transplantation;Other: Placebo | Stanford University | NULL | Not yet recruiting | 2 Years | 25 Years | All | 30 | Phase 1 | United States |
| 2 | NCT04991324 (ClinicalTrials.gov) | September 2022 | 27/7/2021 | Cholecalciferol Comedication in IBD - the 5C Study | Cholecalciferol Comedication in Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C Study | Inflammatory Bowel Diseases | Drug: Vitamin D3 | University Hospital, Basel, Switzerland | NULL | Not yet recruiting | 18 Years | N/A | All | 150 | Phase 3 | NULL |
| 3 | NCT05242471 (ClinicalTrials.gov) | May 20, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2b Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804 | Janssen Research & Development, LLC | NULL | Not yet recruiting | 18 Years | 65 Years | All | 650 | Phase 2 | Italy |
| 4 | NCT05248191 (ClinicalTrials.gov) | April 1, 2022 | 9/2/2022 | FMT for Postop Crohn's Disease | Fecal Microbiota Transplant for Postoperative Crohn's Disease | Crohn Disease | Biological: Capsule fecal microbiota material (cap-FMT);Biological: Colonoscopic fecal microbiota material (colo-FMT) | University of Minnesota | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 1 | United States |
| 5 | NCT05284136 (ClinicalTrials.gov) | April 1, 2022 | 28/2/2022 | Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease | Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE | Crohn Disease | Dietary Supplement: Crohn's disease exclusion diet (CDED);Drug: Oral prednisolone | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 16 Years | 70 Years | All | 80 | Phase 2/Phase 3 | France;Netherlands |
| 6 | NCT05043870 (ClinicalTrials.gov) | April 1, 2022 | 2/9/2021 | Combined Immunosuppression for Pediatric Crohn's Disease | Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease | Crohn Disease;Infliximab;Immunosuppression;Children, Only | Drug: Infliximab and immunosuppressives;Drug: Infliximab | Children's Hospital of Fudan University | NULL | Not yet recruiting | 2 Years | 18 Years | All | 40 | Phase 4 | NULL |
| 7 | NCT04966585 (ClinicalTrials.gov) | March 15, 2022 | 8/7/2021 | Pilot Study of Posaconazole in Crohn's Disease | A Multicenter Randomized, Double-Blinded, Placebo-Controlled Study of Posaconazole in Genetically-Defined Patients With Active Crohn's Disease | Crohn Disease;CARD9 S12N Risk Allele | Drug: Posaconazole Delayed Release Oral Tablet;Drug: Matching Placebo Tablet | Cedars-Sinai Medical Center | NULL | Not yet recruiting | 18 Years | 60 Years | All | 24 | Phase 4 | United States |
| 8 | EUCTR2021-002869-18-BE (EUCTR) | 14/03/2022 | 25/10/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 9 | EUCTR2019-002687-27-HR (EUCTR) | 10/03/2022 | 14/03/2022 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 10 | NCT05242458 (ClinicalTrials.gov) | March 2, 2022 | 15/2/2022 | A Study of Ustekinumab Treatment in Children With Crohn's Disease | Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry Data | Crohn's Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | ImproveCareNow (ICN);Children's Hospital Medical Center, Cincinnati | Not yet recruiting | 2 Years | 25 Years | All | 662 | United States | |
| 11 | NCT04456517 (ClinicalTrials.gov) | March 1, 2022 | 29/6/2020 | Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy | REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea | Crohn's Disease;Inflammatory Bowel Disease | Drug: Ranolazine;Drug: Placebo | Vanderbilt University Medical Center | NULL | Enrolling by invitation | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 12 | NCT05130983 (ClinicalTrials.gov) | March 1, 2022 | 16/11/2021 | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's Disease | A Phase I Study of ExoFlo, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product, for the Treatment of Medically Refractory Crohn's Disease | Crohn Disease;IBD - Irritable Bowel Disease | Drug: Bone Marrow MSC Derived Extracellular Vesicle Isolate | Direct Biologics, LLC | NULL | Not yet recruiting | 18 Years | 75 Years | All | 10 | Phase 1 | NULL |
| 13 | NCT04779320 (ClinicalTrials.gov) | February 28, 2022 | 1/3/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease (CD) | Drug: Vedolizumab IV | Takeda | NULL | Not yet recruiting | 2 Years | 17 Years | All | 120 | Phase 3 | NULL |
| 14 | NCT05262829 (ClinicalTrials.gov) | February 28, 2022 | 8/2/2022 | Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Moderate and Severe Crohn's Disease | A Single-arm, Open-label Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Refractory Moderate to Severe Crohn's Disease | Crohn Disease | Biological: Human Umbilical Cord Mesenchymal Stem Cells | Shanghai East Hospital | NULL | Not yet recruiting | 18 Years | 70 Years | All | 40 | N/A | China |
| 15 | EUCTR2021-002869-18-GR (EUCTR) | 18/02/2022 | 16/11/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 16 | EUCTR2021-002869-18-CZ (EUCTR) | 10/02/2022 | 30/11/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 17 | NCT04777656 (ClinicalTrials.gov) | February 2022 | 26/2/2021 | Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients. | Randomized Trial for Unstable Pediatric Crohn's Disease Patients Comparing the Use of Crohn's Disease Exclusion Diet (CDED) on Top of Standard Therapy Versus Standard Therapy Alone. | Crohn's Disease | Dietary Supplement: Phase1 : CDED/Modulen™IBD® + Maintenance therapy;Dietary Supplement: Phase2 and 3 : | Assistance Publique - Hôpitaux de Paris | URC-CIC Paris Descartes Necker Cochin;MICALIS Institute | Not yet recruiting | 6 Years | 17 Years | All | 120 | Phase 3 | France |
| 18 | NCT05068284 (ClinicalTrials.gov) | January 31, 2022 | 27/9/2021 | A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD | Crohn's Disease | Drug: ABBV-154;Drug: Placebo | AbbVie | NULL | Recruiting | 18 Years | 75 Years | All | 265 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom |
| 19 | EUCTR2020-005770-99-NO (EUCTR) | 20/01/2022 | 23/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Norway KS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 20 | EUCTR2021-002869-18-ES (EUCTR) | 20/01/2022 | 15/09/2021 | This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD) | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD - Moderate to Severe Crohn’s Disease: A Phase 2 Safety and Efficacy Study of ABBV-154 | Subjects with moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 Product Name: ABBV-154 Product Code: ABBV-154 INN or Proposed INN: ABBV-154 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 265 | Phase 2 | United States;Czechia;Taiwan;Slovakia;Greece;Spain;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 21 | NCT05197049 (ClinicalTrials.gov) | January 17, 2022 | 17/1/2022 | A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 318 | Phase 3 | United States;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;China;Croatia;Czechia;France;Germany;Hungary;Italy;Japan;Jordan;Korea, Republic of;Lithuania;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 22 | JPRN-jRCT2071210031 | 15/01/2022 | 01/06/2021 | A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Induction Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >=30 kg will be included in this arm group Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group. Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this armgroup. Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg. Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Baseline weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg. Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg Vedolizumab 100 mg, IV infusion, Q | Shikamura Mitsuhiro | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 3 | United States;Australia;Belgium;Bosnia;Croatia;Czech Republic;Hungary;Germany;Italy;Israel;Lithuania;New Zealand;Poland;Romania;Slovakia;Russia;Ukraine;Spain;United Kingdom;China;Japan |
| 23 | NCT04804540 (ClinicalTrials.gov) | January 10, 2022 | 15/3/2021 | A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease | A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn Disease | Drug: Vedolizumab IV | Takeda | NULL | Not yet recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | NULL |
| 24 | NCT04530877 (ClinicalTrials.gov) | January 1, 2022 | 24/8/2020 | Exclusive Enteral Nutrition vs. Infliximab in Chinese CD Patients | Comparative Effectiveness of Exclusive Enteral Nutrition and Infliximab in Chinese Children With Active Crohn's Disease | Crohn's Disease;Exclusive Enteral Nutrition;Infliximab;Mucosal Healing | Biological: Infliximab;Dietary Supplement: Exclusive Enteral Nutrition | Children's Hospital of Fudan University | NULL | Not yet recruiting | 1 Year | 18 Years | All | 80 | Phase 4 | NULL |
| 25 | NCT05039411 (ClinicalTrials.gov) | January 1, 2022 | 1/9/2021 | Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas Patients With Crohn's Disease | A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease | Perianal Fistula Due to Crohn's Disease;Fistula in Ano | Biological: Human umbilical cord mesenchymal stem cells (UC-MSCs) | CryoCord Sdn Bhd | University of Malaya | Not yet recruiting | 18 Years | N/A | All | 7 | Phase 1 | Malaysia |
| 26 | NCT05075811 (ClinicalTrials.gov) | January 1, 2022 | 28/9/2021 | Study of Ossium Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in the Setting of Crohn's Disease | A Phase IB/IIA Study of Ossium Vertebral Bone Marrow Derived Mesenchymal Stem Cells (vBM-MSC) for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch | Pouch, Ileal;Fistula | Drug: Ossium vBM-MSC;Other: Placebo | Amy Lightner | Ossium Health, Inc. | Not yet recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | United States |
| 27 | NCT04779762 (ClinicalTrials.gov) | January 2022 | 28/2/2021 | Stelara and Diet Trial for Crohns Disease | Stelara and CDED Diet Trial for Crohns Disease | Crohn Disease | Other: Crohn's disease exclusion diet (CDED);Drug: Ustekinumab Injection [Stelara] | Wolfson Medical Center | Sheba Medical Center, Israel | Not yet recruiting | 18 Years | 65 Years | All | 40 | N/A | Israel |
| 28 | NCT04924270 (ClinicalTrials.gov) | January 2022 | 7/6/2021 | Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases | Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial | Rheumatoid Arthritis;Reactive Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Gouty Arthritis;Psoriasis;Hidradenitis Suppurativa;Pulmonary Sarcoidosis;Crohn Disease;Ulcerative Colitis | Biological: Faecal microbiota transplantation;Other: Placebo | Torkell Ellingsen | Region of Southern Denmark;University of Southern Denmark | Not yet recruiting | 18 Years | 70 Years | All | 200 | Phase 2 | NULL |
| 29 | NCT05049525 (ClinicalTrials.gov) | January 2022 | 25/8/2021 | Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease | Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy | Crohn's Disease;Inflammatory Bowel Diseases | Drug: Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.;Drug: Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally. | Montreal Heart Institute | NULL | Not yet recruiting | 18 Years | 65 Years | All | 68 | Phase 2 | NULL |
| 30 | EUCTR2019-001866-14-IT (EUCTR) | 21/12/2021 | 12/10/2021 | Open-label Extension Study of Brazikumab in Crohn's Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE | Moderately to Severely Active Crohn's Disease. MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070 Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 31 | EUCTR2020-004527-16-IT (EUCTR) | 21/12/2021 | 29/09/2021 | A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s Disease | A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment - InCharge | Crohn`s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Stelara 130mg / 26mL concentrate for solution for infusion Product Name: Stelara 130mg / 26mL concentrate for solution for infusion Product Code: [Stelara 130mg / 26mL concentrate for solution for INN or Proposed INN: USTEKINUMAB Product Name: BI 706321 Product Code: [BI 706321] Product Name: BI 706321 Product Code: [BI 706321] Product Name: BI 706321 Product Code: [BI 706321] Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML Product Name: Stelara 90mg/1ml solution for injection in pre-filled syringe (PFS) Product Code: [Stelara 90mg/1ml solution for injecti | BOEHRINGER INGELHEIM INTERNATIONAL GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | France;United States;Czechia;Spain;Poland;Belgium;Italy | ||
| 32 | NCT05029921 (ClinicalTrials.gov) | December 10, 2021 | 30/8/2021 | A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's Disease | A Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | China |
| 33 | EUCTR2020-004775-40-HR (EUCTR) | 07/12/2021 | 16/12/2021 | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 34 | NCT04186247 (ClinicalTrials.gov) | December 2021 | 2/12/2019 | Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD) | Personalized AZithromycin/metronidAZole, in Combination With Standard Induction Therapy, to Achieve a Fecal Microbiome Community Structure and Metagenome Changes Associated With Sustained Remission in Pediatric Crohn's Disease (CD): a Pilot Study | Crohn Disease;Pediatric Crohns Disease | Drug: Azithromycin;Drug: Metronidazole;Other: Standard of Care | University of North Carolina, Chapel Hill | Crohn's and Colitis Foundation;University of Amsterdam | Not yet recruiting | 3 Years | 17 Years | All | 20 | Phase 2 | United States;Canada;Israel;Netherlands |
| 35 | NCT05113095 (ClinicalTrials.gov) | November 30, 2021 | 5/11/2021 | A Survey of Darvadstrocel in People With Crohn's Disease | Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance) | Crohn's Disease | Biological: Darvadstrocel | Takeda | NULL | Recruiting | 20 Years | N/A | All | 275 | Japan | |
| 36 | EUCTR2019-000824-17-SK (EUCTR) | 25/11/2021 | 29/07/2021 | A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease | Patients with Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: BT-11 Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Bosnia and Herzegovina | ||
| 37 | EUCTR2020-005770-99-IT (EUCTR) | 24/11/2021 | 28/09/2021 | A study to test whether spesolimab helps people with Crohn's disease whohave symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trialto evaluate spesolimab (BI 655130) efficacy in patients with fibrostenoticCrohn's Disease - - | Fibrostenotic Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: [BI 655130] INN or Proposed INN: SPESOLIMAB | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Serbia;United States;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Aruba;Australia;Denmark;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 38 | EUCTR2021-000092-37-PL (EUCTR) | 19/11/2021 | 17/08/2021 | A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Belarus;United States;Czechia;Ukraine;Israel;Russian Federation;France;Czech Republic;Canada;Poland;Belgium;Australia;Georgia | ||
| 39 | EUCTR2020-001811-26-BE (EUCTR) | 18/11/2021 | 22/07/2021 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Belgium;Netherlands | ||
| 40 | NCT05078879 (ClinicalTrials.gov) | November 16, 2021 | 14/10/2021 | Empagliflozin as a Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency | A Phase 1 Study of Empagliflozin as Treatment for Severe Congenital Neutropenia Due to G6PC3 Deficiency | Crohn's Disease;Glycogen Metabolism;Inflammatory Bowel Disease (IBD) | Drug: Empagliflozin | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 41 | EUCTR2020-005770-99-NL (EUCTR) | 12/11/2021 | 05/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 42 | EUCTR2020-004775-40-DK (EUCTR) | 11/11/2021 | 04/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 43 | EUCTR2019-001866-14-HU (EUCTR) | 09/11/2021 | 02/08/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 44 | EUCTR2020-005770-99-IE (EUCTR) | 09/11/2021 | 30/07/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Serbia;Portugal;Taiwan;Hong Kong;Spain;Ireland;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 45 | NCT05013385 (ClinicalTrials.gov) | November 9, 2021 | 13/8/2021 | A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction | Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease | Fibrostenotic Crohn´s Disease | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | Austria;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Norway;Sweden |
| 46 | EUCTR2021-000092-37-CZ (EUCTR) | 03/11/2021 | 07/06/2021 | A study of PRA023 in patients with Crohn's Disease | A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PRA023 INN or Proposed INN: Not yet assigned Other descriptive name: PRA023 | Prometheus Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | United States;France;Czechia;Czech Republic;Canada;Poland;Belgium;Ukraine;Australia;Russian Federation;Georgia | ||
| 47 | NCT04835506 (ClinicalTrials.gov) | November 1, 2021 | 5/4/2021 | Proactive IFX Optimization vs SOC in Patients With CD | Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Crohn's Disease: The OPTIMIZE Trial | Crohn Disease | Drug: Infliximab | Beth Israel Deaconess Medical Center | The Leona M. and Harry B. Helmsley Charitable Trust;Icahn School of Medicine at Mount Sinai | Recruiting | 16 Years | N/A | All | 196 | Phase 4 | United States |
| 48 | NCT05057273 (ClinicalTrials.gov) | November 2021 | 16/8/2021 | Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease | A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease | Crohn's Disease | Drug: BT-11 (Omilancor);Biological: adalimumab | Landos Biopharma Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 40 | Phase 2 | NULL |
| 49 | NCT05088369 (ClinicalTrials.gov) | November 2021 | 12/10/2021 | Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201 | A First-in-human, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Intravenous Doses of HM201 (Pegylated Human Adrenomedullin) in Healthy Subjects (Adults) | Ulcerative Colitis;Crohn's Disease | Drug: HM201;Drug: Placebo | Syneos Health | Himuka AM Pharma Corp. | Not yet recruiting | 18 Years | 55 Years | All | 68 | Early Phase 1 | NULL |
| 50 | NCT04629196 (ClinicalTrials.gov) | November 2021 | 10/11/2020 | Induction Optimization With Stelara for Crohn's Disease | Induction Optimization With Stelara for Crohn's Disease | Crohn Disease | Drug: Ustekinumab | NYU Langone Health | NULL | Not yet recruiting | 18 Years | 70 Years | All | 113 | Phase 4 | United States |
| 51 | EUCTR2020-004457-76-PL (EUCTR) | 28/10/2021 | 15/09/2021 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | France;United States;Argentina;Poland;Turkey;Russian Federation;Japan | ||
| 52 | NCT05028946 (ClinicalTrials.gov) | October 28, 2021 | 24/8/2021 | A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease | A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: Foralumab | Tiziana Life Sciences, PLC | NULL | Not yet recruiting | 18 Years | 70 Years | All | 16 | Phase 1 | NULL |
| 53 | EUCTR2019-001866-14-ES (EUCTR) | 27/10/2021 | 30/09/2020 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 | Allergan Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | China;Korea, Republic of;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany | ||
| 54 | EUCTR2020-005770-99-SE (EUCTR) | 20/10/2021 | 02/09/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 55 | EUCTR2018-004346-42-HU (EUCTR) | 15/10/2021 | 31/01/2020 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 56 | EUCTR2020-004775-40-HU (EUCTR) | 15/10/2021 | 09/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland | ||
| 57 | NCT05072782 (ClinicalTrials.gov) | October 15, 2021 | 18/8/2021 | Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL) | Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL) | Crohn Disease | Drug: Infliximab CT-P13;Drug: Immunosuppressors (Thiopurines or Methotrexate) | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Celltrion | Not yet recruiting | 18 Years | 65 Years | All | 360 | Phase 4 | NULL |
| 58 | EUCTR2020-004301-31-IT (EUCTR) | 13/10/2021 | 30/08/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy - - | Moderately to severely active Crohn's disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: Vedolizumab Product Code: [NA] INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | TAKEDA DEVELOPMENT CENTER AMERICAS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 59 | NCT04913467 (ClinicalTrials.gov) | October 8, 2021 | 3/5/2021 | Effect of Ileocolonic Delivered Vitamins and an Anti-Inflammatory Diet on Crohn's Disease and Healthy Volunteers | Potential Effects of Ileocolonic Delivered Vitamins or the Groningen Anti-Inflammatory Diet on Course of Crohn's Disease and the Microbiome of Healthy Volunteers: a Randomized Controlled Trial - The Vita-GrAID Study | Crohn Disease | Other: Groningen Anti-Inflammatory Diet (GrAID);Dietary Supplement: ColoVit capsule;Other: ColoPulse-placebo capsule | University Medical Center Groningen | NULL | Recruiting | 18 Years | 80 Years | All | 510 | N/A | Netherlands |
| 60 | NCT04978493 (ClinicalTrials.gov) | October 4, 2021 | 26/7/2021 | A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's Disease | A Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction Treatment | Crohn Disease | Drug: BI 706321;Drug: ustekinumab;Drug: Placebo | Boehringer Ingelheim | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States;Poland |
| 61 | NCT03712826 (ClinicalTrials.gov) | October 2021 | 16/8/2018 | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Crohn Disease | Drug: Anti-TNF Drug;Drug: Ustekinumab | Hospices Civils de Lyon | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | N/A | France |
| 62 | EUCTR2020-004775-40-BG (EUCTR) | 29/09/2021 | 13/07/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Poland;Bulgaria;Georgia;Germany;Norway;Japan;Belgium;Belarus;Portugal;Philippines;Slovakia;Greece;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina | ||
| 63 | EUCTR2020-004775-40-ES (EUCTR) | 27/09/2021 | 28/09/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 64 | EUCTR2019-001866-14-PL (EUCTR) | 27/09/2021 | 08/09/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 65 | EUCTR2020-004775-40-PT (EUCTR) | 24/09/2021 | 11/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Portugal;Belarus;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 66 | NCT04997733 (ClinicalTrials.gov) | September 22, 2021 | 5/7/2021 | Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | Crohn Disease | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation (placebo) | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 74 Years | All | 150 | Phase 3 | France |
| 67 | EUCTR2020-005770-99-DK (EUCTR) | 22/09/2021 | 20/08/2021 | A study to test whether spesolimab helps people with Crohn’s disease who have symptoms of bowel obstruction | Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease | Fibrostenotic Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Portugal;Serbia;Taiwan;Hong Kong;Spain;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Norway;Japan;Sweden | ||
| 68 | NCT04859088 (ClinicalTrials.gov) | September 20, 2021 | 15/4/2021 | Biologics and Partial Enteral Nutrition Study | Combining Partial Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Adults With Active Ileocolonic Crohn's Disease | Crohn Disease | Dietary Supplement: Partial Enteral Nutrition | NHS Greater Glasgow and Clyde | University of Glasgow | Recruiting | 16 Years | N/A | All | 80 | N/A | United Kingdom |
| 69 | EUCTR2020-004301-31-SK (EUCTR) | 18/09/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of;Canada;United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary | ||
| 70 | EUCTR2020-004461-40-IT (EUCTR) | 15/09/2021 | 18/10/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis - - | moderate to severe Crohn's Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: [BMS-986165] INN or Proposed INN: deucravacitinib | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Germany;Japan | ||
| 71 | EUCTR2020-004775-40-DE (EUCTR) | 14/09/2021 | 04/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Turkey;Czech Republic;Mexico;Canada;Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 72 | NCT04847739 (ClinicalTrials.gov) | September 13, 2021 | 1/4/2021 | Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) | Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) | Perianal Fistula;Crohn's Disease | Procedure: Seton Placement;Drug: AVB-114 | Avobis Bio, LLC | Alimentiv Inc. | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | United States |
| 73 | EUCTR2019-001866-14-DE (EUCTR) | 10/09/2021 | 11/06/2021 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 74 | EUCTR2019-002687-27-LT (EUCTR) | 03/09/2021 | 29/06/2021 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 75 | NCT05033340 (ClinicalTrials.gov) | September 1, 2021 | 23/8/2021 | The Efficacy and Safety of Oral Etrasimod as Therapy for Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Etrasimod;Drug: Placebo | Samia Hassan El-Shishtawy | Arena Pharmaceuticals | Not yet recruiting | 18 Years | 80 Years | All | 5 | Phase 2/Phase 3 | NULL |
| 76 | NCT03992469 (ClinicalTrials.gov) | September 2021 | 18/6/2019 | Study to Evaluate Safety, Tolerability and Efficacy of Oral B-FAHF-2 in Mild-to-Moderate Crohn's Disease | Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease | Crohn's Disease | Drug: BFAHF-2;Drug: Placebo | Icahn School of Medicine at Mount Sinai | NULL | Not yet recruiting | 18 Years | 30 Years | All | 28 | Phase 1 | United States |
| 77 | NCT05040464 (ClinicalTrials.gov) | August 26, 2021 | 26/8/2021 | Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial | Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial | Crohn Disease;Azathioprine;Methotrexate | Drug: AZA capsules;Drug: MTX;Biological: blood sample | Centre Hospitalier Universitaire, Amiens | NULL | Recruiting | 18 Years | N/A | All | 166 | Phase 3 | France |
| 78 | EUCTR2020-004301-31-HR (EUCTR) | 17/08/2021 | 02/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 79 | JPRN-jRCT2031210210 | 16/08/2021 | 28/07/2021 | A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease | A master protocol for a Phase 3, multicenter, open-label, long-term extension study to evaluate the long-term efficacy and safety of mirikizumab in children and adolescents with moderate-to-severe ulcerative colitis or Crohn's Disease - I6T-MC-AMAZ | Ulcerative Colitis / Crohn's Disease - | Drug: Mirikizumab Administered SC Other Name: LY3074828 | Yoshimoto Yusuke | NULL | Recruiting | Not applicable | Not applicable | Both | 5 | Phase 3 | United States;Japan |
| 80 | JPRN-jRCT2031200345 | 11/08/2021 | 05/02/2021 | A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | Crohn Disease | -Ustekinumab Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period. Open- Label UstekinumabIntravenous (IV): Induction Period UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period Ustekinumab SC Every12 Weeks (q12w): Maintenance Period -Placebo Matching placebo will be administered as SC injection. UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period Ustekinumab SC Every12 Weeks (q12w): Maintenance Period | Nishikawa Kazuko | NULL | Recruiting | >= 2age old | < 18age old | Both | 90 | Phase 3 | United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan |
| 81 | EUCTR2020-004775-40-LT (EUCTR) | 10/08/2021 | 07/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 82 | EUCTR2020-004301-31-HU (EUCTR) | 06/08/2021 | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 83 | EUCTR2020-004775-40-CZ (EUCTR) | 04/08/2021 | 09/06/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Romania;Croatia;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 84 | EUCTR2020-004461-40-DE (EUCTR) | 04/08/2021 | 12/05/2021 | Long-term Safety and Efficacy of BMS-986165 in Participants with Crohn’s Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants with Moderate to Severe Crohn’s Disease or Moderate to Severe Ulcerative Colitis | moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: deucravacitinib Product Code: BMS-986165 INN or Proposed INN: deucravacitinib Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Germany;Japan;Romania;Poland;Brazil;Belgium;Canada;Mexico;Hungary;United Kingdom;Czechia;Korea, Republic of;China;Netherlands;Denmark;Australia;France;Switzerland;Italy;Israel;Russian Federation;Ireland;Spain;Taiwan;Portugal;United States | ||
| 85 | NCT05013905 (ClinicalTrials.gov) | July 28, 2021 | 13/8/2021 | A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease | A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: PRA023 IV;Device: Companion diagnostic (CDx) | Prometheus Biosciences, Inc. | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 86 | EUCTR2019-000824-17-HR (EUCTR) | 28/07/2021 | 21/10/2021 | A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease | Patients with Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: BT-11 Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Turkey;Austria;North Macedonia;Poland;Croatia;Albania;Georgia;Bulgaria;Netherlands;Moldova, Republic of;Bosnia and Herzegovina | ||
| 87 | EUCTR2019-002687-27-DE (EUCTR) | 27/07/2021 | 13/04/2021 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 88 | EUCTR2020-004775-40-IT (EUCTR) | 15/07/2021 | 27/01/2022 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - CULTIVATE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Spain;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 89 | ChiCTR2100048717 | 2021-07-01 | 2021-07-13 | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Clinical trial of the efficacy and safety of dipyridamole adjuvant therapy in children with IBD | Crohn's disease | Two groups:Oral dipyridamole; | Guangzhou Women and Children's Medical Center | NULL | Pending | 3 | 18 | Both | Two groups:50; | China | |
| 90 | JPRN-jRCT2033200314 | 30/06/2021 | 20/01/2021 | A Study of Darvadstrocel for Treating of Complex Perianal Fistula in Children and Teenagers With Crohn's Disease | A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects with Crohn's Disease over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks | Crohn's Disease, Complex Perianal Fistula | Darvadstrocel (Cx601), 24 mL suspension of 120 million cells as a perilesional injection, once on Day 0. | Shikamura Mitsuhiro | NULL | Recruiting | >= 4age old | < 18age old | Both | 20 | Phase 3 | Italy;Netherlands;Poland;Spain;Israel;Japan |
| 91 | NCT04701411 (ClinicalTrials.gov) | June 30, 2021 | 6/1/2021 | A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease | A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Darvadstrocel in the Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period for a Total of up to 52 Weeks | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Takeda | Takeda Development Center Americas, Inc. | Recruiting | 4 Years | 17 Years | All | 20 | Phase 3 | Israel;Japan;Netherlands;Poland;Spain |
| 92 | EUCTR2020-004301-31-LT (EUCTR) | 25/06/2021 | 21/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | ||
| 93 | NCT04372108 (ClinicalTrials.gov) | June 24, 2021 | 30/4/2020 | A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis | An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab;Drug: Other Biologic Therapies | Janssen Scientific Affairs, LLC | NULL | Recruiting | 18 Years | N/A | All | 1056 | United States | |
| 94 | EUCTR2019-002687-27-LV (EUCTR) | 17/06/2021 | 11/03/2021 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Israel;Switzerland;Italy;India;Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation | ||
| 95 | EUCTR2019-002687-27-FR (EUCTR) | 10/06/2021 | 04/05/2021 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 96 | JPRN-jRCT2031200371 | 04/06/2021 | 19/02/2021 | A Study of Vedolizumab, given every 4 weeks, in Japanese Participants with Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease who Experienced Secondary Loss of Response During Maintenance Therapy with Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis, Crohn's Disease | Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase. | Shikamura Mitsuhiro | NULL | Recruiting | >= 18age old | <= 80age old | Both | 158 | Phase 3 | Japan |
| 97 | NCT04738942 (ClinicalTrials.gov) | June 4, 2021 | 2/2/2021 | A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | An Open-Label, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous (IV) Vedolizumab Administered Every 4 Weeks (Q4W) in Japanese Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Experienced Secondary Loss of Response During Maintenance Therapy With Vedolizumab IV Administered Every 8 Weeks (Q8W) | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Recruiting | 18 Years | 80 Years | All | 158 | Phase 3 | Japan |
| 98 | EUCTR2020-004301-31-ES (EUCTR) | 02/06/2021 | 01/09/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;China;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Germany;New Zealand;Japan | ||
| 99 | NCT04919252 (ClinicalTrials.gov) | June 1, 2021 | 6/4/2021 | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease and Ulcerative Colitis | Drug: Vedolizumab | Yonsei University | NULL | Not yet recruiting | 19 Years | 70 Years | All | 60 | Phase 3 | Korea, Republic of |
| 100 | NCT04073472 (ClinicalTrials.gov) | June 1, 2021 | 23/8/2019 | Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's | A Phase I Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch | Crohn's Disease;Fistula;Anal Fistula;Pouch, Ileal;Pouches, Ileoanal | Drug: mesenchymal stem cells (MSCs) | The Cleveland Clinic | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 101 | NCT04643483 (ClinicalTrials.gov) | June 2021 | 19/11/2020 | A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease | A Phase 3, Randomized, Double-Blind, Multicenter Study Including an Active Reference Arm to Evaluate Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents (6 to 17 Years of Age) With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Certolizumab pegol;Drug: Adalimumab;Drug: Placebo | UCB Biopharma SRL | NULL | Withdrawn | 6 Years | 17 Years | All | 0 | Phase 3 | NULL |
| 102 | NCT04844606 (ClinicalTrials.gov) | May 26, 2021 | 12/4/2021 | A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) | A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Ulcerative Colitis Chronic;Inflammatory Bowel Diseases;Crohn's Disease | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 2 Years | 19 Years | All | 185 | Phase 3 | United States;Israel;Japan;Korea, Republic of |
| 103 | EUCTR2019-000824-17-BG (EUCTR) | 26/05/2021 | 10/05/2021 | A randomized, Placebo-Controlled, multicenter study to Evaluate Efficacy and Safety of Orally administered BT-11 in patients with Moderate to Severe Crohn’s Disease. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease | Patients with Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BT-11 INN or Proposed INN: BT-11 Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Belarus;Serbia;United States;Slovakia;Spain;Ukraine;Turkey;North Macedonia;Poland;Croatia;Bulgaria;Albania;Georgia;Bosnia and Herzegovina | ||
| 104 | NCT04842149 (ClinicalTrials.gov) | May 21, 2021 | 8/4/2021 | The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease | The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease: a Double-blind, Randomized, Placebo-controlled Study | Crohn Disease | Dietary Supplement: Bif195 capsules;Dietary Supplement: Placebo capsules | Hvidovre University Hospital | Chr Hansen | Recruiting | 18 Years | 75 Years | All | 60 | N/A | Denmark |
| 105 | EUCTR2020-002674-26-DE (EUCTR) | 19/05/2021 | 17/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 106 | EUCTR2019-002687-27-IT (EUCTR) | 18/05/2021 | 30/07/2021 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 107 | NCT05034458 (ClinicalTrials.gov) | May 14, 2021 | 12/6/2021 | Diet in Pediatric Crohn´s Disease Treated With Biologics | Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease. | Crohn's Disease | Dietary Supplement: Crohn's disease exclusion diet | Hospital Italiano de Buenos Aires | NULL | Recruiting | 1 Month | 18 Years | All | 40 | N/A | Argentina |
| 108 | EUCTR2018-002629-51-CZ (EUCTR) | 12/05/2021 | 02/03/2021 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Czechia;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 109 | EUCTR2020-004775-40-NL (EUCTR) | 11/05/2021 | 02/02/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1265 | Phase 2;Phase 3 | Belarus;Portugal;Philippines;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Peru;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 110 | NCT04877990 (ClinicalTrials.gov) | May 7, 2021 | 4/5/2021 | A Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Crohn's Disease or Ulcerative Colitis | An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of BMS-986165 in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis | Crohn Disease;Ulcerative Colitis | Drug: BMS-986165 | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States;Australia;Brazil;China;Germany;Hungary;Italy;Japan;Poland;Romania;Russian Federation;United Kingdom |
| 111 | NCT03870334 (ClinicalTrials.gov) | May 5, 2021 | 8/3/2019 | Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: BT-11 1,000 mg;Drug: Placebo | Landos Biopharma Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;Bulgaria;Poland |
| 112 | NCT04804046 (ClinicalTrials.gov) | April 15, 2021 | 11/3/2021 | Synbiotics and Post-op Crohn's Disease | Defining Microbial and Immune Changes Following Synbiotic Supplementation in Post-operative Crohn's Disease Patients | Crohn's Disease | Dietary Supplement: Synbiotic;Other: Digestible Maltodextrin | University of Alberta | W. Garfield Weston Foundation | Not yet recruiting | 18 Years | 75 Years | All | 36 | N/A | Canada |
| 113 | NCT04673357 (ClinicalTrials.gov) | April 6, 2021 | 14/12/2020 | A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 90 | Phase 3 | United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom |
| 114 | NCT04151225 (ClinicalTrials.gov) | April 5, 2021 | 4/11/2019 | Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease | A Multicentre, Randomised, Double-blind, Placebo-controlled, Repeat Dose, Dose-ranging Phase 2a/2b Study to Evaluate the Safety, Tolerability and Efficacy of an Anti-oncostatin M Monoclonal Antibody (GSK2330811) in Patients With Moderate to Severe Crohn's Disease | Crohns Disease | Drug: GSK2330811;Drug: Placebo | GlaxoSmithKline | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | NULL |
| 115 | NCT04791878 (ClinicalTrials.gov) | April 1, 2021 | 6/3/2021 | Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease | A Phase I Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease | Perianal Fistula Due to Crohn's Disease (Disorder) | Drug: Mesenchymal stem cells | Amy Lightner | NULL | Recruiting | 13 Years | 17 Years | All | 10 | Phase 1 | United States |
| 116 | JPRN-jRCT2031200406 | 27/03/2021 | 10/03/2021 | A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's Disease | A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET | Crohn Disease | Group 1- Standard of Care (SOC) Biological Therapy: Adalimumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy. Group 2: SOC Biological Therapy: Ustekinumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy. | Numaguchi Hirotaka | NULL | Not Recruiting | >= 18age old | <= 65age old | Both | 70 | Phase 2 | Canada;France;Germany;Italy;Spain;United States Of America;Japan |
| 117 | NCT04682522 (ClinicalTrials.gov) | March 21, 2021 | 9/12/2020 | Flagyl Microbiome in Crohn's Disease | Does the Microbiome Change With Flagyl Treatment After Ileocolic Resection for Crohn's Disease | Crohn Disease | Drug: Metronidazole Oral | University of Louisville | NULL | Recruiting | 20 Years | 80 Years | All | 36 | Phase 4 | United States |
| 118 | NCT04795960 (ClinicalTrials.gov) | March 18, 2021 | 9/3/2021 | Microbiome Modification to Enhance Stelara Response in Crohn's Disease | Microbiome Modification to Enhance Stelara Response in Crohn's Disease | Crohn Disease | Dietary Supplement: Low serine diet;Dietary Supplement: High serine diet | University of Michigan | Kenneth Rainin Foundation | Recruiting | 18 Years | 70 Years | All | 10 | N/A | United States |
| 119 | EUCTR2017-001976-48-NL (EUCTR) | 17/03/2021 | 08/10/2020 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 120 | EUCTR2019-004225-24-DE (EUCTR) | 17/03/2021 | 17/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 121 | EUCTR2019-002942-19-DK (EUCTR) | 12/03/2021 | 05/11/2020 | Nordic study of treatment strategy in inflammatory bowel disease | NORDTREATThe Nordic IBD treatment strategy trial – a randomized controlled trial of access to a protein profile | Crohn's disease and Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Imurel INN or Proposed INN: Azathioprine Trade Name: Puri-nethol INN or Proposed INN: MERCAPTOPURINE | Region Örebro län | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 122 | NCT04263831 (ClinicalTrials.gov) | March 11, 2021 | 7/2/2020 | LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE | LOW DOSE IL-2 FOR THE TREATMENT OF CROHN'S DISEASE | Crohn Disease | Drug: Interleukin-2 (aldesleukin). | Boston Children's Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 1/Phase 2 | United States |
| 123 | NCT04655807 (ClinicalTrials.gov) | March 3, 2021 | 30/11/2020 | A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease | A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's Disease | Crohn Disease | Drug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: Ustekinumab | Janssen Research & Development, LLC | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | United States;Canada;France;Germany;Italy;Japan;Spain;Sweden |
| 124 | NCT04921033 (ClinicalTrials.gov) | March 1, 2021 | 4/6/2021 | Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease | Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial | Crohn Disease;Nutrient; Excess;Remission/Regression | Dietary Supplement: EEN (Nestle Modulen®);Drug: Standart of care | Duzce University | NULL | Recruiting | 18 Years | 75 Years | All | 256 | Phase 3 | Turkey |
| 125 | EUCTR2019-002687-27-SK (EUCTR) | 25/02/2021 | 08/12/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 126 | NCT04761952 (ClinicalTrials.gov) | February 13, 2021 | 14/2/2021 | N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease | N-3 Polyunsaturated Fatty Acids Prevent Postoperative Recurrence of Crohn's Disease:a Prospective Randomized Controlled Trial | Inflammatory Bowel Diseases;Crohn Disease;Polyunsaturated Acid Lipidosis | Drug: azathioprine;Drug: infliximab;Drug: N-3 Polyunsaturated Fatty Acids | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Not yet recruiting | 18 Years | 80 Years | All | 236 | N/A | NULL |
| 127 | EUCTR2019-004225-24-BE (EUCTR) | 08/02/2021 | 25/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan | ||
| 128 | EUCTR2017-001976-48-BE (EUCTR) | 22/01/2021 | 26/01/2021 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS-986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 129 | EUCTR2020-002674-26-SK (EUCTR) | 14/01/2021 | 20/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 130 | EUCTR2020-002674-26-CZ (EUCTR) | 13/01/2021 | 18/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 131 | EUCTR2020-002701-26-IT (EUCTR) | 12/01/2021 | 07/04/2021 | A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's Disease | A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-64304500 Product Code: [JNJ-64304500] INN or Proposed INN: JNJ-64304500 Other descriptive name: sezione * D.3.6.2.1 - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane | JANSSEN CILAG INTERNATIONAL NV | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Canada;Spain;Germany;Japan;Italy;Sweden | ||
| 132 | EUCTR2020-002674-26-HU (EUCTR) | 06/01/2021 | 20/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 133 | EUCTR2019-004225-24-HU (EUCTR) | 05/01/2021 | 20/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Russian Federation;Germany;United Kingdom;Japan;Poland;Belgium;United States;Hungary | ||
| 134 | ChiCTR2000036845 | 2021-01-01 | 2020-08-25 | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | A single-center, randomized, controlled study on the effect of proactive therapeutic drug monitoring on the efficacy and cost of adamumab in the treatment of Crohn's disease | Crohn's disease | Proctive treatment drug monitoring group:In the proactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Adalimumab serum trough concentration is going to be monitored at week 8, 16, 24, 32 and 40 after inclusion: 1.If serum trough concentration=11.7 g/ mL, continue&#;Reactive treatment drug monitoring group:In the reactive TDM group, adamumab is 160mg at week 0, 80mg at week 2, and 40mg once every two weeks from week 4 until week 8. Clinical response is assesed at week 8, 16, 24, 32, and 40 after inclusion: 1.If the clinical response is achieved, continue to administer 40mg once every ; | Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Proctive treatment drug monitoring group:60;Reactive treatment drug monitoring group:60; | Phase 4 | China |
| 135 | NCT04713631 (ClinicalTrials.gov) | January 2021 | 3/12/2020 | Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease | Phase 2a Randomised Double-blind Placebo-controlled Trial to Assess Safety, Efficacy of Artesunate & Curcumin in Crohn's Disease Patients, Who Continue to Have Mild to Moderate Disease Activity on an Adequate Dose of Azathioprine | Crohn's Disease | Drug: Artesunate;Drug: Curcumin;Drug: Placebo A;Drug: Placebo C | Sanjay Gandhi Postgraduate Institute of Medical Sciences | St George's University of London, London, UK | Not yet recruiting | 18 Years | 65 Years | All | 40 | Phase 2 | India |
| 136 | NCT04118088 (ClinicalTrials.gov) | December 22, 2020 | 4/10/2019 | A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula | Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Takeda | Takeda Development Center Americas, Inc. | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | Austria;Czechia;France;Germany;Israel;Spain |
| 137 | NCT04224558 (ClinicalTrials.gov) | December 15, 2020 | 4/4/2018 | Stem Cell Transplantation in Crohn's Disease | Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease | Crohn Disease | Drug: Mesna;Drug: Cyclophosphamide;Drug: Filgrastim;Procedure: Apheresis catheter placement;Procedure: Leukapheresis;Drug: Fludarabine;Drug: Methylprednisolone;Drug: Diphenhydramine;Drug: Acetaminophen;Drug: anti-thymocyte globulin (rabbit);Drug: lymphocyte immune globulin;Biological: Peripheral Blood Stem Cell Infusion;Drug: Cytoxan | Cedars-Sinai Medical Center | NULL | Recruiting | 13 Years | 28 Years | All | 15 | Phase 1/Phase 2 | United States |
| 138 | EUCTR2020-002674-26-IT (EUCTR) | 10/12/2020 | 21/05/2021 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. - NA | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 139 | NCT03414788 (ClinicalTrials.gov) | December 7, 2020 | 8/1/2018 | Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease | PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB)-PF-06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF-06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE AND CROHN'S COLITIS SUBJECTS | Inflammatory Bowel Disease | Biological: PF 06687234;Biological: [124I]IB PF 06687234 | Pfizer | NULL | Withdrawn | 18 Years | 75 Years | All | 0 | Phase 1 | United States |
| 140 | EUCTR2020-002674-26-GB (EUCTR) | 02/12/2020 | 26/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 141 | NCT04660136 (ClinicalTrials.gov) | December 1, 2020 | 2/12/2020 | Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients | Usefulness of Contrast-enhanced Ultrasound (CEUS) in Crohn's Disease Pediatric Patients | Crohn's Disease in Pediatric Patient | Biological: contrast enhanced ultrasound | Yonsei University | NULL | Recruiting | 2 Years | 18 Years | All | 20 | Phase 4 | Korea, Republic of |
| 142 | EUCTR2020-002674-26-AT (EUCTR) | 23/11/2020 | 18/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada | ||
| 143 | EUCTR2020-002674-26-SE (EUCTR) | 19/11/2020 | 13/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 144 | NCT04519671 (ClinicalTrials.gov) | November 19, 2020 | 17/8/2020 | Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease | A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Perianal Fistulizing Crohn's Disease | Perianal Crohn Disease;Perianal Fistula;Crohn Disease | Drug: Mesenchymal Stem Cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 145 | NCT04496063 (ClinicalTrials.gov) | November 16, 2020 | 29/6/2020 | USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) | USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study | Crohn's Disease | Drug: Ustekinumab;Drug: Placebo | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Janssen, LP | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 146 | EUCTR2017-003090-34-DK (EUCTR) | 12/11/2020 | 15/06/2020 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Denmark;Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Austria | ||
| 147 | NCT04939337 (ClinicalTrials.gov) | November 12, 2020 | 10/6/2021 | A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease. | Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease. | Crohn's Disease | Drug: TH-SC01 | Jinling Hospital, China | Jiangsu Topcel-KH Pharmaceutical Co., Ltd | Enrolling by invitation | 18 Years | 70 Years | All | 24 | Phase 1 | China |
| 148 | EUCTR2020-002674-26-NL (EUCTR) | 29/10/2020 | 15/09/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 149 | NCT04519684 (ClinicalTrials.gov) | October 28, 2020 | 17/8/2020 | Study of Mesenchymal Stem Cells for the Treatment of Ileal Pouch Fistula's in Participants With Crohn's Disease | A Phase IB/IIA Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Ileal Anal Anastomosis and Ileal Pouch Fistulas in the Setting of Crohn's Disease of the Pouch | Ileal Pouch;Crohn Disease | Drug: Mesenchymal stem cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 150 | NCT04519697 (ClinicalTrials.gov) | October 28, 2020 | 17/8/2020 | Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease | A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease. | Rectovaginal Fistula;Crohn Disease;Crohn Disease of Vulva;Rectolabial; Fistula | Drug: Mesenchymal Stem Cells;Other: Placebo | Amy Lightner | NULL | Recruiting | 18 Years | 75 Years | Female | 40 | Phase 1/Phase 2 | United States |
| 151 | ChiCTR2000035737 | 2020-10-01 | 2020-08-16 | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Application of indocyanine green fluorescence angiography in preventing anastomotic recurrence after Crohn’s disease intestinal resection and anastomosis: a single-center, prospective, randomized controlled trial | Crohn's disease | Experimental group:The scope of surgical resection was determined by indocyanine green fluorescence angiography;Control group:The scope of surgical resection (2cm away from the lesion site) determined by the physician based on experience; | Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Experimental group:45;Control group:45; | China | |
| 152 | NCT04535882 (ClinicalTrials.gov) | October 1, 2020 | 28/8/2020 | Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD | Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis | LRG Levels | Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels | Showa Inan General Hospital | NULL | Recruiting | N/A | N/A | All | 125 | Japan | |
| 153 | NCT04590508 (ClinicalTrials.gov) | October 1, 2020 | 28/9/2020 | A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease | A Phase 2 Clinical Trial: Xanthohumol Metabolism and Signature (XMaS) in Crohn's Disease | Crohn Disease | Drug: Xanthohumol;Other: Placebo | National University of Natural Medicine | Oregon State University;Pacific Northwest National Laboratory | Recruiting | 21 Years | 50 Years | All | 32 | Phase 2 | United States |
| 154 | NCT04308850 (ClinicalTrials.gov) | October 2020 | 24/2/2020 | Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency | Exploring the Effects of Vitamin D Supplementation on the Chronic Course of Patients With Crohn's Disease With Vitamin D Deficiency,a Prospective Cohort Study | Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement | Drug: Vitamin D drops | Second Affiliated Hospital of Wenzhou Medical University | NULL | Not yet recruiting | N/A | N/A | All | 60 | Early Phase 1 | China |
| 155 | NCT04276636 (ClinicalTrials.gov) | October 2020 | 17/2/2020 | Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency | Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency,a Prospective Cohort Study | Crohn's Disease;Vitamin D Deficiency;Vitamin D Supplement | Drug: Caltrate Pill | Second Affiliated Hospital of Wenzhou Medical University | NULL | Not yet recruiting | N/A | N/A | All | 60 | Early Phase 1 | China |
| 156 | EUCTR2020-001811-26-NL (EUCTR) | 30/09/2020 | 08/07/2020 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Netherlands | ||
| 157 | NCT04524611 (ClinicalTrials.gov) | September 30, 2020 | 20/8/2020 | Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) | A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy | Crohn's Disease (CD) | Drug: Risankizumab;Drug: Ustekinumab | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 508 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 158 | EUCTR2018-004614-18-DK (EUCTR) | 08/09/2020 | 05/08/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 159 | EUCTR2018-004346-42-IT (EUCTR) | 03/09/2020 | 24/05/2021 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease - 52-Week Phase 2b/3 Crohn's Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® Product Name: NA Product Code: [NA] INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: [Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Huma INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anticorpo monoclonale umano anti-Interleuchina-23 Immunoglobulina G2 (IgG2); precedentemente denominato MEDI2070 e AMG 139 | ALLERGAN LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 160 | ChiCTR2100048113 | 2020-09-01 | 2021-07-02 | Study on the efficacy of selenium supplementation in patients with Crohn's disease and low selenium level | Study on the efficacy of selenium supplementation in patients with Crohn's disease and low selenium level | Crohn's Disease | Experimental group:selenium supplementation;Control group:N/A; | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 18 | 65 | Both | Experimental group:60;Control group:30; | China | |
| 161 | NCT04502303 (ClinicalTrials.gov) | September 2020 | 4/8/2020 | 18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease | A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT | Crohn Disease | Diagnostic Test: 18F-FDG and 68Ga-FAPI PET/CT | Peking Union Medical College Hospital | NULL | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 2 | NULL |
| 162 | NCT04398836 (ClinicalTrials.gov) | September 2020 | 18/7/2019 | Preoperative Nutrition for Crohn's Disease Patients | Preoperative Nutrition for Crohn's Disease Patients | Malnutrition;Crohn Disease | Dietary Supplement: Exclusive Enteral Nutrition;Other: High energy / protein diet.;Other: Standard nutrition | Tel-Aviv Sourasky Medical Center | NULL | Not yet recruiting | 18 Years | 70 Years | All | 144 | Phase 3 | Israel |
| 163 | EUCTR2018-004614-18-HR (EUCTR) | 24/08/2020 | 23/11/2020 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 164 | NCT03943446 (ClinicalTrials.gov) | August 14, 2020 | 7/5/2019 | A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence | Crohn Disease | Drug: TAK-018;Drug: TAK-018 Placebo | Takeda | Takeda Development Center Americas, Inc. | Active, not recruiting | 18 Years | N/A | All | 96 | Phase 2 | United States;Austria;France;Germany;United Kingdom;Netherlands |
| 165 | EUCTR2019-002895-14-NL (EUCTR) | 05/08/2020 | 23/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 166 | EUCTR2019-002895-14-GB (EUCTR) | 05/08/2020 | 02/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - CULTIVATE APD334-202 | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Slovenia;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China | ||
| 167 | NCT04362735 (ClinicalTrials.gov) | August 1, 2020 | 19/4/2020 | Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy | Efficacy of Vedolizumab in Crohn's Disease Patients Naive to Biological Therapy: a Brazilian Multicentric Observational Real-world Study | Crohn Disease | Drug: Vedolizumab | Pontifícia Universidade Católica do Paraná | Takeda | Not yet recruiting | 18 Years | N/A | All | 100 | NULL | |
| 168 | NCT04976491 (ClinicalTrials.gov) | August 1, 2020 | 14/11/2019 | Based on the Special Disease Management of Crohn's Disease Diet Studies | Based on the Special Disease Management of Crohn's Disease Diet Studies --a Multicenter, Randomized, Controlled and Open Label Study | Inflammatory Bowel Diseases | Dietary Supplement: CD-C-Food | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 6 Years | 15 Years | All | 5 | China | |
| 169 | EUCTR2019-002895-14-PT (EUCTR) | 27/07/2020 | 06/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Portugal;Belarus;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 170 | NCT04312659 (ClinicalTrials.gov) | July 15, 2020 | 3/3/2020 | A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease | A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease | Crohn Disease | Drug: Infliximab | Johnson & Johnson (China) Investment Ltd. | NULL | Active, not recruiting | 6 Years | 17 Years | All | 39 | China | |
| 171 | EUCTR2019-003335-37-DE (EUCTR) | 29/06/2020 | 27/11/2019 | A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET | Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-67864238 Product Code: JNJ-67864238 INN or Proposed INN: Not available Other descriptive name: PTG-200 | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 172 | NCT04232553 (ClinicalTrials.gov) | June 22, 2020 | 15/1/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease | Crohn's Disease | Drug: Mirikizumab | Eli Lilly and Company | NULL | Recruiting | 18 Years | N/A | All | 778 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 173 | EUCTR2017-001240-35-FR (EUCTR) | 22/06/2020 | 09/03/2020 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;China;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia | ||
| 174 | NCT04163016 (ClinicalTrials.gov) | June 19, 2020 | 24/10/2019 | A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis | Drug: Pharmacokinetics of certolizumab pegol | UCB Biopharma S.P.R.L. | NULL | Recruiting | 18 Years | N/A | Female | 20 | Phase 1 | United States;Canada;France;Germany;Netherlands;Spain;Switzerland |
| 175 | EUCTR2018-004346-42-AT (EUCTR) | 18/06/2020 | 21/01/2020 | A study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severly Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Astrazeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;Korea, Republic of | ||
| 176 | JPRN-JapicCTI-205298 | 10/6/2020 | 26/05/2020 | A Study of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Guselkumab will be administered intravenously for the first 3 doses and then subcutaneously for the subsequent doses. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 25 | Phase 3 | Japan | |
| 177 | NCT04397263 (ClinicalTrials.gov) | June 10, 2020 | 18/5/2020 | A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohns Disease | Drug: Guselkumab | Janssen Pharmaceutical K.K. | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 3 | Japan |
| 178 | EUCTR2019-002687-27-NL (EUCTR) | 28/05/2020 | 18/05/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 179 | EUCTR2018-004346-42-BG (EUCTR) | 28/05/2020 | 08/01/2020 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;South Africa;Bulgaria;Germany | ||
| 180 | EUCTR2019-002895-14-BG (EUCTR) | 21/05/2020 | 23/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 181 | EUCTR2018-004614-18-LT (EUCTR) | 20/05/2020 | 25/11/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | ||
| 182 | EUCTR2019-001673-93-DE (EUCTR) | 19/05/2020 | 02/03/2020 | A study to test long-term treatment with spesolimab in patients with fistulising Crohn’s disease who took part in previous trials. | An open label, long term safety trial of spesolimab treatment in patients with fistulising Crohn’s disease who have completed previous spesolimab trials | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Code: BI 655130 INN or Proposed INN: Spesolilmab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 183 | EUCTR2018-004346-42-RO (EUCTR) | 19/05/2020 | 18/03/2022 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;South Africa;Germany | ||
| 184 | NCT04362254 (ClinicalTrials.gov) | May 15, 2020 | 23/4/2020 | A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials | An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Fistulising Crohn's Disease Who Have Completed Previous Spesolimab Trials | Crohn Disease | Drug: Spesolimab | Boehringer Ingelheim | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 2 | Austria;Belgium;Germany;Korea, Republic of;Netherlands |
| 185 | EUCTR2019-002895-14-ES (EUCTR) | 14/05/2020 | 15/05/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;Netherlands;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 186 | EUCTR2019-000176-41-HU (EUCTR) | 07/05/2020 | 16/03/2020 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy | ||
| 187 | EUCTR2019-000886-19-AT (EUCTR) | 06/05/2020 | 06/09/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | France;United States;Austria;Netherlands;Germany;United Kingdom | ||
| 188 | EUCTR2019-002895-14-NO (EUCTR) | 04/05/2020 | 20/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;Belarus;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 189 | ChiCTR2000031344 | 2020-05-01 | 2020-03-28 | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Endoscopic Stricturotomy combined with local injection of bleomycin in the treatment of primary anorectal stricture in crohn's disease: a Prospective, double-blind, randomized controlled clinical study | Crohn's disease | Group 1:Endoscopic Stricturotomy;Group 2:Endoscopic Stricturotomy combined with local bleomycin injection; | The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | Both | Group 1:35;Group 2:35; | China | |||
| 190 | EUCTR2019-002687-27-HU (EUCTR) | 28/04/2020 | 09/03/2020 | A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Crohn's Disease - VIVID-2 | Crohn´s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 778 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan | ||
| 191 | EUCTR2019-004219-29-NL (EUCTR) | 21/04/2020 | 04/02/2020 | Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease | Personalized AZithromycin/metronidAZole, in combination with standard induction therapy, to achieve a fecal microbiome community structure and metagenome changes associated with sustained remission in pediatric Crohn’s Disease (CD): a pilot study” - PAZAZ | Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Azithromycin Product Name: Azithromycin INN or Proposed INN: Azithromycin Other descriptive name: AZITHROMYCIN Trade Name: Metronidazole Product Name: Metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: METRONIDAZOLE | Amsterdam UMC | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Canada;Israel;Netherlands | ||
| 192 | NCT03905109 (ClinicalTrials.gov) | April 15, 2020 | 3/4/2019 | Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease | A Phase 2a, Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety of ABX464 Compared With Placebo in Patients With Moderate to Severe Active Crohn's Disease Who Have Inadequate Response, Loss of Response, or Intolerance to Prior Amino-salicylates, Immunosuppressant Treatment, Biologics, and/or Corticosteroid Treatment | Crohn Disease | Drug: ABX464;Drug: Placebo | Abivax S.A. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Belgium |
| 193 | EUCTR2018-004346-42-BE (EUCTR) | 15/04/2020 | 03/03/2020 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | ||
| 194 | NCT04239248 (ClinicalTrials.gov) | April 1, 2020 | 27/11/2019 | Tasty&Healthy Dietary Approach for Crohn's Disease | Tasty&Healthy is Not a Diet But a Dietary Approach: Randomized Controlled Trials of Excluding Pro-inflammatory Nutrients for Inducing and Maintaining Remission in Crohn's Disease | Crohn Disease | Dietary Supplement: Tasty&Healthy intervention group;Dietary Supplement: EEN intervention group | Shaare Zedek Medical Center | NULL | Recruiting | 6 Years | 24 Years | All | 192 | N/A | Israel |
| 195 | EUCTR2018-004346-42-CZ (EUCTR) | 24/03/2020 | 22/01/2020 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 221 | Phase 2;Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of | ||
| 196 | EUCTR2018-002629-51-GB (EUCTR) | 16/03/2020 | 08/01/2020 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 197 | EUCTR2017-001976-48-FR (EUCTR) | 06/03/2020 | 09/07/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | United States;Portugal;Taiwan;Spain;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 198 | NCT03492944 (ClinicalTrials.gov) | March 6, 2020 | 12/2/2018 | Contrast Enhanced Ultrasound in Human Crohn's Disease-Lumason | Contrast-Enhanced Ultrasound Evaluation of Bowel Wall Inflammation in Pediatric Crohn's Disease: Comparison to CT and MRI Enterography | Crohn Disease | Drug: Ultrasound Microbubble Contrast Agent;Device: Ultrasound Imaging | Children's Hospital Medical Center, Cincinnati | NULL | Recruiting | 10 Years | 18 Years | All | 25 | United States | |
| 199 | EUCTR2019-000886-19-NL (EUCTR) | 06/03/2020 | 17/09/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Austria;Germany;Netherlands;United Kingdom | ||
| 200 | ChiCTR2000029323 | 2020-03-01 | 2020-01-25 | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Laparoscopic bowel resection combined with infliximab treatment versus infliximab for localized intestinal Crohn's disease: a randomized controlled, open-label trial | Crohn's disease | Experimental group:Laparoscopic bowel resection combined with postoperative Infliximab treatment;Control group:Infliximab; | Renji Hospital, School of Medicine, Shanghai Jiaotong University | NULL | Pending | 18 | 80 | Both | Experimental group:30;Control group:30; | China | |
| 201 | NCT04014517 (ClinicalTrials.gov) | March 1, 2020 | 8/7/2019 | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | Crohn Disease | Other: Standard of Care;Dietary Supplement: Immunonutrition | Istituto Clinico Humanitas | NULL | Not yet recruiting | 18 Years | N/A | All | 350 | N/A | NULL |
| 202 | NCT04273399 (ClinicalTrials.gov) | March 2020 | 8/1/2020 | High-impact Exercise in Adults With Crohn's Disease | Feasibility of High-impact Exercise to Improve Musculoskeletal Outcomes in Adults With Crohn's Disease | Crohn Disease | Other: High-impact exercise intervention;Other: Acute response to high-impact exercise | NHS Greater Glasgow and Clyde | University of Glasgow | Not yet recruiting | 18 Years | 40 Years | All | 30 | N/A | United Kingdom |
| 203 | EUCTR2019-002895-14-SK (EUCTR) | 26/02/2020 | 10/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;Japan;Norway;Germany;Georgia;Bulgaria;Poland;Belgium;Argentina;Hungary;Egypt;United Kingdom;Lithuania;Slovenia;China;South Africa | ||
| 204 | NCT03850509 (ClinicalTrials.gov) | February 25, 2020 | 15/2/2019 | Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation | Efficacy and Safety of Oral OPS-2071 in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | Crohn's Disease | Drug: OPS-2071 150 mg;Drug: OPS-2071 300 mg;Drug: OPS-2071 600 mg;Drug: Matching Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Iqvia Pty Ltd | Terminated | 18 Years | 70 Years | All | 3 | Phase 2 | United States;Poland |
| 205 | EUCTR2018-004614-18-LV (EUCTR) | 19/02/2020 | 12/12/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 206 | EUCTR2019-002895-14-FR (EUCTR) | 17/02/2020 | 08/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States | ||
| 207 | NCT04254783 (ClinicalTrials.gov) | February 16, 2020 | 3/2/2020 | A Study to Evaluate the Effect of Intravenous (IV) Infusions of Risankizumab on Pharmacokinetics of Cytochome P450 Substrates in Adult Participants With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | A Phase 1 Study to Evaluate the Effect of Multiple IV Infusions of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates Administered Orally in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis (UC);Crohn's Disease | Drug: Risankizumab;Drug: Cytochrome P450 (CYP) Substrates | AbbVie | NULL | Recruiting | 18 Years | 80 Years | All | 20 | Phase 1 | United States;Germany;Israel |
| 208 | EUCTR2019-002895-14-LT (EUCTR) | 13/02/2020 | 19/12/2019 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 209 | NCT04173273 (ClinicalTrials.gov) | February 12, 2020 | 20/11/2019 | A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 18 Years | 80 Years | All | 1265 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Colombia;Czechia;Denmark;Egypt;France;Georgia;Germany;Greece;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Moldova, Republic of;Netherlands;Philippines;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine |
| 210 | EUCTR2019-000176-41-IT (EUCTR) | 11/02/2020 | 05/11/2020 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment - - | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071 Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071 Product Name: OPS-2071 Product Code: [OPS-2071] INN or Proposed INN: OPS-2071 | Otsuka Pharmaceutical Development and Commercialization, Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Hungary;Canada;Poland;Belgium;Germany;Italy | ||
| 211 | ChiCTR2000029543 | 2020-02-08 | 2020-02-03 | A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease | A Model with serum biomarkers to Predict Infliximab Response in Patients with Crohn's Disease | Crohn's Disease | Gold Standard:Histology pathological examination; SES-CD endoscopy score;Index test:ELISA test for multiple serum cytokines; | The First Hospital Affiliated to Sun Yat sen University | NULL | Recruiting | Both | Target condition:350;Difficult condition:0 | China | |||
| 212 | NCT03999580 (ClinicalTrials.gov) | February 7, 2020 | 24/6/2019 | The Vitamin D in Pediatric Crohn's Disease ( ViDiPeC-2 ) | A Pragmatic Randomized Controlled Trial on High Dose Vitamin D to Prevent Relapses of Crohn's Disease in Children | Crohn Disease | Drug: vitamin D3 | Jantchou Prevost | NULL | Recruiting | 4 Years | 18 Years | All | 316 | Phase 3 | Canada |
| 213 | NCT03950336 (ClinicalTrials.gov) | February 4, 2020 | 13/5/2019 | Prebiotics and Diet to Reduce Leaky Gut in First Degree Relatives of Crohn's Disease Patients | Influence of Prebiotics on Intestinal Permeability in First Degree Relatives of Crohn's Patients | Healthy First Degree Relatives of Crohn's Disease Patients | Dietary Supplement: Prebiotics;Other: Low n-6 PUFA Diet;Dietary Supplement: Maltodextrin;Other: Control Diet | University of Alberta | NULL | Recruiting | 15 Years | 50 Years | All | 32 | N/A | Canada |
| 214 | EUCTR2019-002895-14-HU (EUCTR) | 03/02/2020 | 04/02/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Switzerland;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 215 | EUCTR2019-000852-32-NL (EUCTR) | 30/01/2020 | 08/10/2019 | A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. | A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study | Inflammatory Bowel Disease, Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Naltrexone hydrochloride | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 122 | Phase 2 | Netherlands | ||
| 216 | EUCTR2019-000886-19-FR (EUCTR) | 20/01/2020 | 26/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: None at this time Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: None at this time Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Germany;United Kingdom | ||
| 217 | EUCTR2019-000176-41-PL (EUCTR) | 17/01/2020 | 06/09/2019 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Belgium;Poland;Germany;Italy | ||
| 218 | EUCTR2019-002895-14-IT (EUCTR) | 16/01/2020 | 22/01/2021 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - APD334-202 | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: [APD334] INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | ARENA PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Peru;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Lithuania | ||
| 219 | EUCTR2019-002895-14-GR (EUCTR) | 14/01/2020 | 03/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Bulgaria;Georgia;Germany;Norway;Japan | ||
| 220 | NCT04225689 (ClinicalTrials.gov) | January 10, 2020 | 20/12/2019 | The Intensive Post Exclusive Enteral Nutrition Study | The Intensive Post Exclusive Enteral Nutrition Study (iPENS): A Randomised Trial to Evaluate CD-TREAT Diet as a Food Reintroduction Regime in Children and Young Adults With Crohn's Disease | Crohn Disease | Other: CD-TREAT diet | NHS Greater Glasgow and Clyde | University of Glasgow | Recruiting | 6 Years | 17 Years | All | 58 | N/A | United Kingdom |
| 221 | EUCTR2019-002895-14-CZ (EUCTR) | 09/01/2020 | 09/01/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belarus;Portugal;Taiwan;Slovakia;Greece;Thailand;Ukraine;Chile;Italy;India;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Spain;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Australia;Peru;South Africa;China;Slovenia;Lithuania;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Georgia;Bulgaria;Germany;Norway;Japan | ||
| 222 | NCT03961815 (ClinicalTrials.gov) | January 6, 2020 | 8/5/2019 | Open-label Extension Study of Brazikumab in Crohn's Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) | Crohn's Disease;IBD | Drug: Brazikumab Induction Dose;Drug: Brazikumab Maintenance Dose | AstraZeneca | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 161 | Phase 3 | United States;Austria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 223 | NCT04233463 (ClinicalTrials.gov) | January 2020 | 15/1/2020 | The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease | The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized Study | Crohn Disease | Dietary Supplement: Modulen;Drug: Budesonide | Hillel Yaffe Medical Center | NULL | Not yet recruiting | 18 Years | 70 Years | All | 50 | N/A | Israel |
| 224 | EUCTR2018-004346-42-ES (EUCTR) | 26/12/2019 | 11/11/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 225 | EUCTR2019-003662-40-DE (EUCTR) | 18/12/2019 | 22/10/2019 | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) | Prospective, open-label, single-arm, single-center phase IV clinical trial to evaluate efficacy and safety of the adalimumab biosimilar Amgevita in subjects with moderate to severe active chronic inflammatory bowel diesease (Crohn's disease and ulcerative colitis) - Amgevita de novo in CED | MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Amgevita 40 mg Injektionslösung in einer Fertigspritze INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita 40 mg Injektionslösung im Fertigpen INN or Proposed INN: ADALIMUMAB | Universitätsklinikum Erlangen | NULL | Not Recruiting | Female: yes Male: yes | 82 | Phase 4 | Germany | ||
| 226 | EUCTR2019-003335-37-IT (EUCTR) | 18/12/2019 | 17/01/2022 | A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238 - PRISM-SCARLET | Treatment of moderately to severely active Crohn’s disease with JNJ-67864238. MedDRA version: 20.0;Level: PT;Classification code 10021425;Term: Immune system disorder;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-67864238 Product Code: [JNJ-67864238] | JANSSEN CILAG INTERNATIONAL NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | United States;Argentina;Poland;Russian Federation;Germany;Italy | ||
| 227 | EUCTR2019-003816-29-FR (EUCTR) | 16/12/2019 | 14/10/2019 | Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal | Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE | Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Fecal microbiota Product Name: Fecal microbiota | ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 228 | EUCTR2017-001976-48-PT (EUCTR) | 16/12/2019 | 22/05/2019 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 229 | EUCTR2018-004346-42-DE (EUCTR) | 10/12/2019 | 17/06/2019 | A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In) - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070' Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: MEDI2070 INN or Proposed INN: BRAZIKUMAB Other descriptive name: MEDI2070 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 553 | Phase 2;Phase 3 | Belgium;Poland;Bulgaria;South Africa;Germany;China;Korea, Republic of;Canada;Hungary;Czech Republic;France;India;Italy;United Kingdom;Russian Federation;Israel;Austria;Ukraine;Spain;Slovakia;Taiwan;Czechia;United States | ||
| 230 | EUCTR2019-000333-39-IT (EUCTR) | 09/12/2019 | 24/05/2021 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study - Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | Perianal fistulising Crohn´s disease MedDRA version: 20.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Alofisel Product Name: Cx601 Product Code: [Cx601] INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 231 | NCT03915262 (ClinicalTrials.gov) | December 2, 2019 | 9/4/2019 | Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease | Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy | Crohn Disease | Biological: Search for exocrine pancreatic insufficiency at week 0 and 12 | Hospices Civils de Lyon | NULL | Recruiting | 18 Years | N/A | All | 50 | France | |
| 232 | EUCTR2017-004294-14-FR (EUCTR) | 02/12/2019 | 09/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 535 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Serbia;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Turkey;Korea, Republic of;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Denmark;Puerto Rico;France;Italy;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Belarus | ||
| 233 | NCT02677350 (ClinicalTrials.gov) | December 1, 2019 | 1/2/2016 | AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE) | A Phase I, Pilot Trial to Evaluate the Safety and Efficacy of Injection of Allogeneic Mesenchymal Bone-Marrow Derived Human Stem Cells in Patients With Fistulizing Crohn's Disease. | Crohn's Disease;Fistulizing Crohn's Disease;Stem Cells | Drug: Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs) | Joshua M Hare | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 234 | NCT04134065 (ClinicalTrials.gov) | December 1, 2019 | 17/10/2019 | the Effect of Vitamin D in Crohn's Disease | the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease | Vitamin D Deficiency;Crohn Disease | Drug: Vitamin D;Drug: Placebo oral capsule | Nanjing University School of Medicine | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting | 20 Years | 60 Years | All | 30 | Early Phase 1 | NULL |
| 235 | EUCTR2019-001087-30-AT (EUCTR) | 28/11/2019 | 12/09/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Ireland;Chile;Israel;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Ukraine;Spain;Greece;Slovakia;Serbia;Belarus;United States | ||
| 236 | EUCTR2017-001240-35-SI (EUCTR) | 27/11/2019 | 12/11/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 237 | NCT04213729 (ClinicalTrials.gov) | November 26, 2019 | 24/12/2019 | Diet Intervention for Crohn's Disease Patient | A Holistic Diet Intervention for People With Crohn's Disease | Crohn Disease | Behavioral: Diet Counseling;Other: CD LFD;Behavioral: Dyadic Psychological Support (DPS) | University of Miami | The Leona M. and Harry B. Helmsley Charitable Trust | Recruiting | 18 Years | 70 Years | All | 300 | N/A | United States |
| 238 | EUCTR2019-000886-19-DE (EUCTR) | 26/11/2019 | 29/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Takeda Development Center Americas,Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | France;United States;Austria;Netherlands;Germany;United Kingdom | ||
| 239 | NCT04164849 (ClinicalTrials.gov) | November 22, 2019 | 8/11/2019 | Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid | Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid | Crohn Disease | Drug: 5-aminolevulinic acid;Procedure: Blue light photopheresis;Procedure: Transfusion;Procedure: Continuous Mononuclear Cell Collection (CMNC);Procedure: Red light photopheresis | University Hospital, Akershus | Oslo University Hospital | Recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | Norway |
| 240 | EUCTR2018-001895-39-HR (EUCTR) | 21/11/2019 | 20/01/2020 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 241 | EUCTR2019-003068-39-NL (EUCTR) | 20/11/2019 | 04/11/2019 | In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels. | Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study | Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Infliximab Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | UMC Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Netherlands | ||
| 242 | EUCTR2017-004293-33-FR (EUCTR) | 12/11/2019 | 09/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 675 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 243 | EUCTR2018-002629-51-AT (EUCTR) | 12/11/2019 | 27/06/2019 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden | ||
| 244 | EUCTR2019-001087-30-HR (EUCTR) | 11/11/2019 | 17/01/2020 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 245 | ChiCTR1900027370 | 2019-11-11 | 2019-11-10 | The pathogenic genes and flora of Crohn's disease with anal fistula | The pathogenic genes and flora of Crohn's disease with anal fistula | Crohn's disease with anal fistula | CD anal fistula and CD without anal fistula:N/A; | Nanfang Hospital, Southern Medical University | NULL | Recruiting | Both | CD anal fistula and CD without anal fistula:50; | N/A | China | ||
| 246 | EUCTR2019-000886-19-GB (EUCTR) | 06/11/2019 | 29/07/2019 | A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resection | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence - TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 Product Code: TAK-018 INN or Proposed INN: sibofimloc Other descriptive name: EB8018 | Millennium Pharmaceuticals, Inc (a wholly owned subsidiary | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Austria;Netherlands;Germany;United Kingdom | ||
| 247 | EUCTR2018-004346-42-FR (EUCTR) | 05/11/2019 | 10/07/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | Allergan Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 248 | EUCTR2017-004292-31-FR (EUCTR) | 05/11/2019 | 09/08/2019 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 675 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 249 | NCT04075825 (ClinicalTrials.gov) | November 4, 2019 | 22/8/2019 | Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula | A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study | Crohn's Disease;Complex Perianal Fistula | Biological: Darvadstrocel | Millennium Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Belgium;Czechia;France;Hungary;Israel;Italy;Poland;Spain |
| 250 | NCT04154735 (ClinicalTrials.gov) | November 2019 | 8/3/2019 | Autologous Transplant Targeted Against Crohn's | Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease | Crohn's Disease | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: Tacrolimus | Northwestern University | NULL | Withdrawn | 18 Years | 49 Years | All | 0 | Phase 2 | United States |
| 251 | EUCTR2019-001087-30-DE (EUCTR) | 31/10/2019 | 01/07/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 252 | EUCTR2019-001087-30-BG (EUCTR) | 30/10/2019 | 24/10/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Estonia;Slovakia;Portugal;Serbia;Belarus;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 253 | NCT03945019 (ClinicalTrials.gov) | October 28, 2019 | 8/5/2019 | CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Biological: CT-P13 SC (Infliximab);Other: Placebo SC | Celltrion | NULL | Active, not recruiting | 18 Years | 75 Years | All | 397 | Phase 3 | Poland;United States |
| 254 | NCT03962998 (ClinicalTrials.gov) | October 27, 2019 | 22/5/2019 | A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's Disease | A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohn's Disease | Crohn Disease | Drug: Lactulose/Rhamnose solution;Drug: MB-102 | MediBeacon | NULL | Recruiting | 18 Years | N/A | All | 20 | Early Phase 1 | United States |
| 255 | EUCTR2019-002093-32-SE (EUCTR) | 24/10/2019 | 28/06/2019 | A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease. | Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease. | None.Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial.Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated. MedDRA version: 22.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Product Name: Lumentin 44 Product Code: L 44 INN or Proposed INN: Egg Albumen Powder Other descriptive name: EGG WHITE PROTEIN Trade Name: Movprep | Lument AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Sweden | ||
| 256 | EUCTR2018-004614-18-NL (EUCTR) | 21/10/2019 | 27/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 257 | NCT04131504 (ClinicalTrials.gov) | October 16, 2019 | 16/10/2019 | Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION) | A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF | Crohn's Disease;IBD | Drug: Infliximab;Drug: Adalimumab | Children's Hospital Medical Center, Cincinnati | The Leona M. and Harry B. Helmsley Charitable Trust | Active, not recruiting | 1 Year | 22 Years | All | 239 | United States | |
| 258 | EUCTR2018-004614-18-DE (EUCTR) | 15/10/2019 | 25/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden | ||
| 259 | NCT03914261 (ClinicalTrials.gov) | October 15, 2019 | 11/4/2019 | Expanded Access to Risankizumab | Expanded Access to Risankizumab | Crohn's Disease;Ulcerative Colitis (UC) | Drug: Risankizumab | AbbVie | NULL | Available | 18 Years | N/A | All | Belgium;Israel;Spain;Switzerland;United States | ||
| 260 | EUCTR2018-004614-18-IT (EUCTR) | 09/10/2019 | 30/07/2021 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: [LY3074828] INN or Proposed INN: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: [LY3074828] INN or Proposed INN: Mirikizumab Trade Name: STELARA 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB Product Name: MIRIKIZUMAB Product Code: [ | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 261 | EUCTR2017-004295-55-FR (EUCTR) | 08/10/2019 | 09/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;New Zealand;Japan;Norway;Germany;Georgia;Bulgaria;Singapore;Poland;Belgium;Argentina;Hungary;United Kingdom;Austria;Lithuania;Finland;Slovenia;China;Netherlands;South Africa;Australia;Switzerland;Russian Federation | ||
| 262 | JPRN-jRCT1031190056 | 30/09/2019 | 17/07/2019 | E6011-CS1 study | Research for medicinal predictive marker on Crohn's disease - E6011-CS1 study | Crohn's disease Crohn's disease;D003424 | Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit. 1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination 2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination 3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination Study2:None. | Mikami Yohei | EA Pharma Co.,Ltd.(Utilize AMED's funds) | Not Recruiting | >= 16age old | Not applicable | Both | 32 | N/A | Japan |
| 263 | EUCTR2018-001895-39-NL (EUCTR) | 27/09/2019 | 03/06/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 264 | EUCTR2018-002629-51-IT (EUCTR) | 26/09/2019 | 15/06/2021 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA - 90 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 1.0 ML (90 MG/ML) 1 FLACONCINO Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB Other descriptive name: ustekinumab Trade Name: STELARA - 45 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 0.5 ML (90 MG/ML) 1 FLACONCINO Product Name: USTEKINUMAB Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 265 | NCT04102111 (ClinicalTrials.gov) | September 23, 2019 | 23/9/2019 | A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: JNJ-67864238;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 90 | Phase 2 | United States;Argentina;Germany;Italy;Poland;Russian Federation;Ukraine;France |
| 266 | ChiCTR1900026091 | 2019-09-19 | 2019-09-20 | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease | Development of a predictive nomogram for primary non-response to infliximab in patients with Crhon's disease: a multicenter study | Crohn's disease | Case series:infliximab; | The First Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 9 | 58 | Both | Case series:343; | China | |
| 267 | NCT03718182 (ClinicalTrials.gov) | September 17, 2019 | 23/10/2018 | Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? | Can Vitamin D Supplementation in People With Crohn's Disease Improve Symptoms as an Adjunct Therapy? D-CODE Feasibility Randomised Controlled Trial | Crohn Disease;Vitamin D Deficiency | Dietary Supplement: Cholecalciferol | University Hospital Birmingham NHS Foundation Trust | National Institute for Health Research, United Kingdom;University of Birmingham;Clinical Trials Research Centre | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United Kingdom |
| 268 | EUCTR2018-004614-18-GB (EUCTR) | 16/09/2019 | 20/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia | ||
| 269 | EUCTR2018-004614-18-ES (EUCTR) | 12/09/2019 | 04/07/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe | Lilly S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 270 | EUCTR2018-004614-18-FR (EUCTR) | 11/09/2019 | 20/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 271 | EUCTR2019-001087-30-IT (EUCTR) | 10/09/2019 | 17/01/2022 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease - / | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Inflectra Product Name: / Product Code: [CT-P13] INN or Proposed INN: INFLIXIMAB Trade Name: Remisma Product Name: 00000 Product Code: [CT-P13] INN or Proposed INN: INFLIXIMAB INN or Proposed INN: INFLIXIMAB | CELLTRION INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan | ||
| 272 | EUCTR2018-004346-42-GB (EUCTR) | 10/09/2019 | 30/05/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Czechia;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;South Africa;Bulgaria;Germany;Netherlands;Sweden | ||
| 273 | EUCTR2017-004588-11-NL (EUCTR) | 10/09/2019 | 10/09/2019 | Control Crohn Safe Trial: Long term outcome and tolerability of six months adalimumab as initial treatment for newly diagnosed Crohn's disease versus standard step-up treatment. | Control Crohn Safe Trial: Long term efficacy and safety of periodic treatment with adalimumab versus standard step-care for newly diagnosed Crohn's disease. - CoCroS trial | The chronic inflammatory bowel disease Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira | University Maastricht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 4 | Netherlands | ||
| 274 | EUCTR2019-001087-30-PL (EUCTR) | 09/09/2019 | 24/06/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Brazil;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 275 | EUCTR2018-001895-39-BG (EUCTR) | 05/09/2019 | 16/07/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 276 | EUCTR2018-004614-18-PL (EUCTR) | 03/09/2019 | 09/07/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 277 | EUCTR2019-001087-30-GR (EUCTR) | 28/08/2019 | 26/07/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 278 | EUCTR2019-001087-30-ES (EUCTR) | 14/08/2019 | 10/09/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 279 | EUCTR2019-001087-30-FR (EUCTR) | 13/08/2019 | 14/06/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 280 | EUCTR2018-002109-70-CZ (EUCTR) | 12/08/2019 | 27/12/2018 | A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease | Early phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable | Active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: E6011 INN or Proposed INN: Undetermined Other descriptive name: IGG2 ANTIBODIES | EA Pharma Co., Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Czechia;Hungary;Czech Republic;Poland;Russian Federation;Japan | ||
| 281 | EUCTR2019-001087-30-HU (EUCTR) | 09/08/2019 | 10/08/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 282 | EUCTR2019-001087-30-CZ (EUCTR) | 06/08/2019 | 06/06/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSINA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 283 | EUCTR2018-002629-51-FR (EUCTR) | 31/07/2019 | 24/04/2019 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Spain;Netherlands;Germany;Sweden | ||
| 284 | EUCTR2018-004614-18-HU (EUCTR) | 25/07/2019 | 11/06/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden | ||
| 285 | EUCTR2019-001087-30-LV (EUCTR) | 25/07/2019 | 04/06/2019 | Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) as maintenance therapy in patients with Crohn's disease | A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB | Celltrion, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Italy;India;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany | ||
| 286 | NCT03926130 (ClinicalTrials.gov) | July 23, 2019 | 23/4/2019 | A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Mirikizumab;Drug: Ustekinumab;Drug: Placebo | Eli Lilly and Company | NULL | Recruiting | 15 Years | 80 Years | All | 1150 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Sweden |
| 287 | EUCTR2016-003191-50-FR (EUCTR) | 17/07/2019 | 28/01/2019 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 288 | EUCTR2017-001226-18-SI (EUCTR) | 15/07/2019 | 06/03/2019 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden;Portugal | ||
| 289 | EUCTR2018-004614-18-AT (EUCTR) | 10/07/2019 | 28/05/2019 | Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 | moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: MIRIKIZUMAB Product Code: LY3074828 INN or Proposed INN: Mirikizumab Other descriptive name: MIRIKIZUMAB Trade Name: STELARA 130 mg concentrate for solution for infusion INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Product Name: MIRIKIZUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden | ||
| 290 | NCT04056442 (ClinicalTrials.gov) | July 7, 2019 | 13/8/2019 | A Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Crossover, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Steroid-dependent Crohn's Disease Patients | Steroid Dependent Crohn's Disease | Drug: Cannabidiol , synthetic form;Drug: Placebo | Stero Biotechs Ltd. | NULL | Recruiting | 18 Years | N/A | All | 28 | Phase 2 | Israel |
| 291 | JPRN-JapicCTI-194830 | 01/7/2019 | 27/06/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's disease | Intervention name : Vedolizumab (Genetical Recombination) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | pending | BOTH | 300 | NA | Japan | ||
| 292 | ChiCTR1900023696 | 2019-07-01 | 2019-06-08 | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial | Chron's disease | Group 1:EBD;Group 2:EBD combined with local injection of betamethasone; | The Sixth Affiliated Hospital of Sun Yat-sen University | NULL | Pending | 18 | 75 | Both | Group 1:45;Group 2:45; | N/A | China |
| 293 | NCT04002180 (ClinicalTrials.gov) | July 1, 2019 | 26/6/2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease] | Crohn's Disease | Drug: Vedolizumab (Genetical Recombination) | Takeda | NULL | Recruiting | N/A | N/A | All | 300 | Japan | |
| 294 | NCT04089514 (ClinicalTrials.gov) | June 30, 2019 | 12/9/2019 | A Real-world Study of Imraldi® Use | Pan-EU Real-World Experience With Imraldi® | Arthritis, Rheumatoid (RA);Axial Spondyloarthritis (axSpA);Arthritis, Psoriatic (PsA);Crohn's Disease (CD);Colitis, Ulcerative (UC) | Drug: Adalimumab | Biogen | NULL | Completed | 18 Years | N/A | All | 1000 | Belgium;Germany;Ireland;Italy;Spain;United Kingdom | |
| 295 | EUCTR2019-000717-37-ES (EUCTR) | 27/06/2019 | 28/06/2019 | Loss of response of the Adalimumba biosimilar compared with the original drug | LOSS OF RESPONSE OF THE ADALIMUMAB BIOSIMILAR COMPARED WITH THE LOSS OF RESPONSE OF THE ADALIMUMAB ORIGINAL: CONTROLLED, RANDOMIZED, NON-INFERIORITY OPEN STUDY.ADA-SWITCH Study - ADA-SWITCH Study | Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AMGEVITA® Product Name: AMGEVITA (Adalimumab biosimilar ) Trade Name: HUMIRA ® Product Name: Humira (adalimumab original) | Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI) | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Spain | ||
| 296 | EUCTR2019-002038-35-BE (EUCTR) | 27/06/2019 | 07/06/2019 | A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients | A prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Stelara INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | UZ Leuven | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Belgium | ||
| 297 | EUCTR2017-004997-32-DE (EUCTR) | 25/06/2019 | 14/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 298 | EUCTR2018-001895-39-CZ (EUCTR) | 06/06/2019 | 05/03/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 2 | United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 299 | EUCTR2017-002195-13-GB (EUCTR) | 05/06/2019 | 28/02/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 300 | NCT03559660 (ClinicalTrials.gov) | May 20, 2019 | 5/6/2018 | CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) | Crohn's Disease | Drug: Certolizumab Pegol | UCB Biopharma S.P.R.L. | NULL | Available | 18 Years | N/A | All | NULL | ||
| 301 | NCT03677648 (ClinicalTrials.gov) | May 14, 2019 | 17/9/2018 | A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease | A Phase II Randomized, Placebo Controlled, Double-blind, Four Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: SHR0302;Drug: Placebos | Reistone Biopharma Company Limited | NULL | Active, not recruiting | 18 Years | 75 Years | All | 144 | Phase 2 | United States;China;Poland;Ukraine |
| 302 | EUCTR2017-003090-34-HU (EUCTR) | 10/05/2019 | 25/03/2019 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Belgium;Austria;Netherlands;Germany | ||
| 303 | EUCTR2016-003190-17-FR (EUCTR) | 07/05/2019 | 14/03/2019 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 304 | ChiCTR1900022728 | 2019-05-01 | 2019-04-23 | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Cohort study combined with omics screening for the early diagnostic markers in Crohn's disease | Crohn's disease | Gold Standard:Clinical outcome;Index test:Comprehensive serological markers, metabolomics, intestinal microbes, pathological features, imaging features of clinical subclinical CD, combined with clinical and endoscopic features, to explore early diagnosis of CD; | The 7th Medical Center of the PLA General Hospital (Army general hospital) | NULL | Pending | Both | Target condition:310;Difficult condition:160 | China | |||
| 305 | NCT03808103 (ClinicalTrials.gov) | May 1, 2019 | 4/1/2019 | Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease | A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD) | Crohn Disease | Biological: Placebo;Biological: Bacteriophage preparation | Intralytix, Inc. | MOUNT SINAI HOSPITAL | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 306 | EUCTR2018-003594-95-NL (EUCTR) | 30/04/2019 | 30/04/2019 | Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy | Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response | Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 307 | NCT03733314 (ClinicalTrials.gov) | April 25, 2019 | 5/11/2018 | A Study of E6011 in Participants With Active Crohn's Disease | Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | EA Pharma Co., Ltd. | NULL | Recruiting | 18 Years | 64 Years | All | 40 | Phase 2 | Czechia;Hungary;Japan;Poland;Russian Federation |
| 308 | EUCTR2018-002629-51-SE (EUCTR) | 23/04/2019 | 29/01/2019 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;Czechia;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 309 | EUCTR2017-001225-41-SI (EUCTR) | 19/04/2019 | 06/03/2019 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 310 | EUCTR2017-003090-34-NL (EUCTR) | 16/04/2019 | 19/12/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Netherlands BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Korea, Republic of | ||
| 311 | EUCTR2018-002109-70-HU (EUCTR) | 15/04/2019 | 20/11/2018 | A research aimed study to test the efficacy and safety of a new medical product, called E6011, in treating Crohn’s disease, which is a type of inflammatory bowel disease | Early phase 2 clinical trial of E6011 in patients with active Crohn’s disease - Not applicable | Active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: E6011 INN or Proposed INN: Undetermined Other descriptive name: IGG2 ANTIBODIES | EA Pharma Co., Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Hungary;Poland;Japan | ||
| 312 | EUCTR2018-002064-15-NL (EUCTR) | 15/04/2019 | 15/04/2019 | Patient preference model: treatment of perianal fistulas in Crohn's disease | Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 4 | Netherlands | ||
| 313 | EUCTR2017-001976-48-DK (EUCTR) | 15/04/2019 | 29/01/2019 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Bouvet Island;Czechia;United Kingdom;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden | ||
| 314 | NCT03942120 (ClinicalTrials.gov) | April 8, 2019 | 7/5/2019 | Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab) | Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARA | Crohn Disease | Drug: Ustekinumab | Janssen Korea, Ltd., Korea | NULL | Recruiting | 18 Years | N/A | All | 70 | Korea, Republic of | |
| 315 | EUCTR2018-001272-37-HR (EUCTR) | 05/04/2019 | 17/05/2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 316 | NCT03884439 (ClinicalTrials.gov) | March 18, 2019 | 4/3/2019 | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Crohn's Disease;Ulcerative Colitis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | NULL | Recruiting | N/A | N/A | All | 300 | Japan | |
| 317 | EUCTR2017-002195-13-PT (EUCTR) | 18/03/2019 | 23/07/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 318 | EUCTR2018-003303-19-PL (EUCTR) | 15/03/2019 | 23/01/2019 | A Phase II Study in Patients With Moderate to Severe Active Crohn’s Disease. | A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Crohn’s Disease. | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHR0302 INN or Proposed INN: Pending | Reistone Biopharma Company Limited | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | United States;Poland;Ukraine;China | ||
| 319 | EUCTR2017-001226-18-IE (EUCTR) | 08/03/2019 | 05/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 320 | EUCTR2017-001240-35-IE (EUCTR) | 08/03/2019 | 05/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 321 | EUCTR2017-001225-41-IE (EUCTR) | 08/03/2019 | 13/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 322 | NCT03706456 (ClinicalTrials.gov) | March 6, 2019 | 11/10/2018 | Phase 3 Study of Cx601 in Subjects With Complex Perianal Fistulising Crohn's Disease | A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Complex Perianal Fistulas in Adult Patients With Crohn's Disease | Biological: Darvadstrocel | Takeda | NULL | Active, not recruiting | 18 Years | N/A | All | 22 | Phase 3 | Japan |
| 323 | JPRN-JapicCTI-184145 | 06/3/2019 | 10/10/2018 | Phase 3 Study of Cx601 in Subjects with Complex Perianal Fistulising Crohn's Disease | A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients with Crohn's Disease | Complex perianal fistulas in adult patients with Crohn's disease | Intervention name : Darvadstrocel INN of the intervention : Darvadstrocel Dosage And administration of the intervention : Darvadstrocel (Cx601) of cell suspension 24 milliliters (mL), intralesional injection, once dose on Day 1. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | BOTH | 22 | Phase 3 | Japan | |
| 324 | NCT03901937 (ClinicalTrials.gov) | March 1, 2019 | 12/3/2019 | The Effects of Parenteral ?-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease | Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China | Crohn Disease | Drug: ?-3 polyunsaturated fatty acid;Procedure: Intestinal surgery for Crohn's Disease | Sir Run Run Shaw Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 158 | Phase 4 | China |
| 325 | EUCTR2017-000575-88-GB (EUCTR) | 28/02/2019 | 11/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1032 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan | ||
| 326 | EUCTR2017-000617-23-GB (EUCTR) | 28/02/2019 | 11/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 327 | EUCTR2017-000576-29-GR (EUCTR) | 26/02/2019 | 25/02/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 328 | EUCTR2017-000574-11-GR (EUCTR) | 26/02/2019 | 27/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 329 | EUCTR2017-000617-23-GR (EUCTR) | 26/02/2019 | 21/02/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 330 | EUCTR2018-001272-37-PT (EUCTR) | 25/02/2019 | 30/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 331 | EUCTR2018-001272-37-AT (EUCTR) | 25/02/2019 | 21/09/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 332 | NCT03681067 (ClinicalTrials.gov) | February 20, 2019 | 20/8/2018 | A Clinical Trial of Antibody GSK1070806 in the Treatment of Patients With Moderate to Severe Crohn's Disease | A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients With Moderate-to-Severe Crohn's Disease | Crohn Disease | Drug: GSK1070806;Drug: Placebo- sodium chloride | University of Birmingham | GlaxoSmithKline;University Hospital Birmingham | Completed | 16 Years | N/A | All | 5 | Phase 1/Phase 2 | United Kingdom |
| 333 | EUCTR2017-003090-34-DE (EUCTR) | 18/02/2019 | 15/11/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Netherlands;Germany;Korea, Republic of;Hungary;Spain;Belgium;Denmark;Austria | ||
| 334 | EUCTR2016-005199-90-SK (EUCTR) | 14/02/2019 | 14/02/2018 | Open Label Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. | An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects with Active Crohn’s Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study - RHB-104-04 and MAP (US2) | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Australia;Israel;New Zealand | ||
| 335 | EUCTR2017-000617-23-IT (EUCTR) | 11/02/2019 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Phase 3 | Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Portugal;Serbia;United States | ||
| 336 | EUCTR2017-000575-88-IT (EUCTR) | 11/02/2019 | 22/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MadCam Antibody Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: Anti-MAdCAM antibody | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Greece;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan;New Zealand | ||
| 337 | NCT03681652 (ClinicalTrials.gov) | February 11, 2019 | 20/9/2018 | Post-Operative Crohn's Disease Outcome in Children | Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study | Crohn Disease | Drug: Azathioprine;Drug: Anti-TNF Drug | Schneider Children's Medical Center, Israel | NULL | Recruiting | 6 Years | 18 Years | All | 100 | Israel | |
| 338 | NCT03627091 (ClinicalTrials.gov) | February 6, 2019 | 24/7/2018 | Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307) | Crohn's Disease | Drug: Ontamalimab;Other: Placebo | Shire | NULL | Completed | 16 Years | 80 Years | All | 40 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Croatia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Turkey;Ukraine;United Kingdom |
| 339 | EUCTR2017-003090-34-AT (EUCTR) | 05/02/2019 | 11/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 340 | NCT03752970 (ClinicalTrials.gov) | February 5, 2019 | 22/11/2018 | A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease | Crohn Disease | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | 75 Years | All | 27 | Phase 2 | Austria;Belgium;Denmark;Germany;Hungary;Korea, Republic of;Netherlands;Spain |
| 341 | EUCTR2017-004295-55-PT (EUCTR) | 04/02/2019 | 01/10/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 342 | EUCTR2017-004997-32-HU (EUCTR) | 04/02/2019 | 04/04/2019 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 343 | NCT03850600 (ClinicalTrials.gov) | January 30, 2019 | 15/2/2019 | Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease | The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease | Crohn Disease;Pregnancy | Other: Diet-CD | Icahn School of Medicine at Mount Sinai | The Leona M. and Harry B. Helmsley Charitable Trust;University of Massachusetts, Worcester | Recruiting | 18 Years | N/A | Female | 396 | N/A | United States |
| 344 | EUCTR2017-004997-32-NL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 345 | EUCTR2016-000634-21-FR (EUCTR) | 28/01/2019 | 08/11/2018 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 693 | Phase 2 | United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 346 | NCT03650413 (ClinicalTrials.gov) | January 14, 2019 | 16/8/2018 | An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: UTTR1147A | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 143 | Phase 2 | United States;Bulgaria;Georgia;Germany;Greece;Ireland;Italy;Moldova, Republic of;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France;Hungary;Israel;Netherlands |
| 347 | EUCTR2017-000575-88-HR (EUCTR) | 11/01/2019 | 16/05/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | New Zealand;Japan;Netherlands;Germany;South Africa;Australia;Croatia;Romania;Poland;Brazil;Czech Republic;Italy;United Kingdom;Israel;Russian Federation;Austria;Lithuania;Czechia;Serbia;United States | ||
| 348 | EUCTR2017-000617-23-HR (EUCTR) | 11/01/2019 | 16/05/2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 349 | EUCTR2017-004997-32-IT (EUCTR) | 10/01/2019 | 18/06/2021 | Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE - NA | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) Product Code: [NA] | GENENTECH, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 350 | EUCTR2018-001272-37-FR (EUCTR) | 10/01/2019 | 23/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 351 | EUCTR2018-002629-51-NL (EUCTR) | 08/01/2019 | 12/11/2018 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 352 | EUCTR2017-004997-32-GB (EUCTR) | 04/01/2019 | 09/10/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Germany;Netherlands;Bulgaria;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Israel;Ireland;Ukraine;Spain;Greece;Serbia;United States | ||
| 353 | EUCTR2017-001225-41-HR (EUCTR) | 31/12/2018 | 21/05/2019 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 354 | EUCTR2018-002925-47-ES (EUCTR) | 28/12/2018 | 16/11/2018 | prediction of response to therapy in inflammatory bowel disease | Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches | Inflammatory bowel disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Vedolizumab INN or Proposed INN: VEDOLIZUMAB Other descriptive name: VEDOLIZUMAB | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain | ||
| 355 | EUCTR2017-001976-48-DE (EUCTR) | 20/12/2018 | 22/08/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Czechia;Taiwan;Spain;Ireland;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 356 | EUCTR2017-001976-48-IT (EUCTR) | 20/12/2018 | 28/01/2021 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: [BMS-986165] Other descriptive name: BMS986165 | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Czechia;Taiwan;Spain;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Australia;Denmark;Germany;Korea, Republic of | ||
| 357 | NCT03782376 (ClinicalTrials.gov) | December 20, 2018 | 11/12/2018 | A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2 | Janssen-Cilag Ltd. | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Austria;Czechia;France;Germany;Italy;Korea, Republic of;Netherlands;Russian Federation;Spain;Sweden;United Kingdom |
| 358 | JPRN-jRCT1051190043 | 20/12/2018 | 02/09/2019 | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 | Crohn's disease | At the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week. | Takehara Tetsuo | Iijima Hideki | Recruiting | 20age | Not applicable | Both | 15 | Phase 2 | Japan |
| 359 | EUCTR2017-001240-35-HR (EUCTR) | 20/12/2018 | 21/05/2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 360 | EUCTR2017-001226-18-HR (EUCTR) | 19/12/2018 | 21/05/2019 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 645 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Serbia;Estonia;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 361 | ChiCTR1800019958 | 2018-12-16 | 2018-12-09 | Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease | Combining infliximab with Hyperbaric Oxygen Therapy in Patients With Perianal Crohn's Disease | Crohn's disease | Case series:Combining infliximab treatmentwith Hyperbaric Oxygen Therapy; | Daping Hospital, Army Medical University (Third Military Medical University) | NULL | Recruiting | 18 | 65 | Both | Case series:60; | China | |
| 362 | EUCTR2017-004997-32-IE (EUCTR) | 14/12/2018 | 13/12/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: efmarodocokin alfa INN or Proposed INN: efmarodocokin alfa Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;Hungary;Poland;Bulgaria;Netherlands;Germany | ||
| 363 | EUCTR2017-004295-55-BE (EUCTR) | 13/12/2018 | 30/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 364 | EUCTR2018-002001-65-GB (EUCTR) | 13/12/2018 | 01/10/2018 | A clinical trial of antibody GSK1070806 in the treatment of patients with moderate to severe Crohn’s Disease | A Phase Ib/IIb, Randomised, Double Blind, Placebo-Controlled Trial to Investigate the Safety, Tolerability and Clinical Activity of Humanised Antibody GSK1070806 in the Treatment of Patients with Moderate-to-Severe Crohn’s Disease - CDAID GSK1070806 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1070806 INN or Proposed INN: GSK1070806 Other descriptive name: fully humanised, recombinant monoclonal antibody (IgG1) | University of Birmingham | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 365 | EUCTR2018-002629-51-ES (EUCTR) | 12/12/2018 | 16/11/2018 | A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract | A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Spain;Netherlands;Germany;Sweden | ||
| 366 | EUCTR2017-004997-32-ES (EUCTR) | 10/12/2018 | 17/09/2018 | A Study to Evaluate the Long Term Safety and Tolerability of UTTR1147A in Patients with Moderate to Severe Ulcerative Colitis or Crohn's Disease | A PHASE II OPEN LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR CROHN'S DISEASE | Ulcerative Colitis (UC) or Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc | Roche Farma, S.A por delegación de Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 320 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | ||
| 367 | NCT03759288 (ClinicalTrials.gov) | December 7, 2018 | 20/11/2018 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In) | Crohn's Disease;IBD | Drug: Brazikumab low dose;Drug: Brazikumab high dose;Drug: Humira®;Drug: Placebo | AstraZeneca | NULL | Recruiting | 18 Years | 80 Years | All | 928 | Phase 2/Phase 3 | United States;Australia;Austria;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Romania |
| 368 | EUCTR2018-001272-37-DE (EUCTR) | 04/12/2018 | 26/07/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 369 | NCT03378167 (ClinicalTrials.gov) | December 1, 2018 | 12/12/2017 | PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial | PediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot Study | Crohn Disease;Pediatric Crohns Disease;Inflammatory Bowel Diseases;Colitis | Biological: MICROBIOTA;Biological: PLACEBO | McMaster Children's Hospital | Hamilton Health Sciences Corporation;McMaster University | Recruiting | 3 Years | 17 Years | All | 45 | Phase 1 | Canada |
| 370 | NCT02834754 (ClinicalTrials.gov) | December 1, 2018 | 12/7/2016 | Vedolizumab Post Op Study | A Randomized, Double-blind, Placebo Controlled Study of Vedolizumab for the Prevention of Post-operative Crohn's Disease Recurrence | Crohn's Disease | Drug: Vedolizumab;Drug: placebo | Marc Schwartz | Takeda | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 371 | EUCTR2017-004294-14-DK (EUCTR) | 30/11/2018 | 27/08/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 535 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 372 | EUCTR2017-004295-55-DK (EUCTR) | 30/11/2018 | 27/08/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 373 | EUCTR2018-001272-37-GR (EUCTR) | 28/11/2018 | 09/11/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 374 | EUCTR2017-003090-34-BE (EUCTR) | 28/11/2018 | 12/10/2018 | A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease | Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD | Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 | SCS Boehringer Ingelheim Comm.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 28 | Phase 2 | Hungary;Spain;Belgium;Denmark;Austria;Netherlands;Germany;Korea, Republic of | ||
| 375 | NCT03729674 (ClinicalTrials.gov) | November 26, 2018 | 11/10/2018 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease | Drug: Biosimilar;Drug: Originator (legacy) drug | McGill University Health Centre/Research Institute of the McGill University Health Centre | Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group | Recruiting | 18 Years | N/A | All | 800 | Canada | |
| 376 | EUCTR2017-001976-48-ES (EUCTR) | 23/11/2018 | 17/07/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Romania;Australia;Germany;Korea, Republic of | ||
| 377 | NCT03635112 (ClinicalTrials.gov) | November 19, 2018 | 31/7/2018 | Efficacy and Safety of TD-1473 in Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy With 2 Doses of TD-1473 in Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: TD-1473 | Theravance Biopharma | NULL | Active, not recruiting | 18 Years | N/A | All | 167 | Phase 2 | United States;Australia;Austria;Bulgaria;Croatia;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom |
| 378 | EUCTR2018-001272-37-GB (EUCTR) | 15/11/2018 | 03/10/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo?Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - DIONE - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;United States;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 379 | EUCTR2017-000575-88-DE (EUCTR) | 13/11/2018 | 28/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan;Lithuania;Austria;Russian Federation;Israel;United States;Serbia | ||
| 380 | EUCTR2017-000617-23-DE (EUCTR) | 13/11/2018 | 28/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 381 | EUCTR2018-001272-37-ES (EUCTR) | 11/11/2018 | 09/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Croatia;Romania;South Africa;Bulgaria;Georgia;Germany | ||
| 382 | EUCTR2017-004293-33-SI (EUCTR) | 06/11/2018 | 12/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 383 | EUCTR2017-004295-55-SI (EUCTR) | 06/11/2018 | 13/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 384 | EUCTR2017-004294-14-SI (EUCTR) | 06/11/2018 | 13/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary | ||
| 385 | EUCTR2017-002195-13-IT (EUCTR) | 05/11/2018 | 22/01/2021 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: [CNTO1959] INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: [CNTO1959] INN or Proposed INN: Guselkumab Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 386 | EUCTR2015-003759-23-NO (EUCTR) | 02/11/2018 | 07/12/2020 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand | ||
| 387 | EUCTR2017-004294-14-PT (EUCTR) | 29/10/2018 | 16/07/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn¿s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn¿s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan;United States;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Turkey;Korea, Republic of;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Denmark;Puerto Rico;France;Italy;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Belarus;Portugal | ||
| 388 | EUCTR2017-005151-83-DE (EUCTR) | 26/10/2018 | 09/07/2018 | Treatment of Crohn's disease with Ustekinumab in clinical practice | INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: STELARA Product Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA Product Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Charité Universitätsmedizin Berlin | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Germany | ||
| 389 | NCT03833596 (ClinicalTrials.gov) | October 25, 2018 | 21/12/2018 | Exclusive Enteral Nutrition and Corticosteroids Therapy in Crohn's Disease (EENCD) | Synergistic Effect of Exclusive Enteral Nutrition Formula in Addition to Corticosteroids Therapy to Induce Clinical Remission in Patients With Crohn's Disease: a Pilot Study Involving a Multidimensional Assessment of Potential Mechanisms | Crohn's Disease | Drug: Prednisone;Dietary Supplement: Exclusive Enteral Nutrition | McMaster University | Nestlé | Terminated | 18 Years | 75 Years | All | 3 | Phase 4 | Canada |
| 390 | EUCTR2017-004209-41-BE (EUCTR) | 25/10/2018 | 21/08/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 391 | EUCTR2017-004294-14-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 392 | EUCTR2017-004295-55-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 393 | EUCTR2017-004293-33-NL (EUCTR) | 22/10/2018 | 12/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 394 | EUCTR2017-004209-41-DE (EUCTR) | 16/10/2018 | 21/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 395 | EUCTR2018-001272-37-HU (EUCTR) | 16/10/2018 | 16/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 396 | EUCTR2017-004294-14-FI (EUCTR) | 10/10/2018 | 30/07/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 535 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 397 | EUCTR2017-004293-33-FI (EUCTR) | 10/10/2018 | 30/07/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 675 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 398 | EUCTR2017-004295-55-FI (EUCTR) | 10/10/2018 | 31/07/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 399 | EUCTR2018-001272-37-BG (EUCTR) | 09/10/2018 | 31/08/2018 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Crohn's Disease | A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Induction Therapy with 2 Doses of TD-1473 in Subjects with Moderately-to-Severely Active Crohn’s Disease - Efficacy and Safety of TD-1473 in Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not Assigned Other descriptive name: THRX-139060 | Theravance Biopharma Ireland Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Portugal;Serbia;United States;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;South Africa;Germany;New Zealand;Korea, Republic of | ||
| 400 | EUCTR2017-000617-23-BE (EUCTR) | 08/10/2018 | 02/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 401 | EUCTR2017-000576-29-BE (EUCTR) | 08/10/2018 | 02/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 402 | EUCTR2017-000617-23-PT (EUCTR) | 08/10/2018 | 01/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 403 | EUCTR2017-003359-43-DE (EUCTR) | 04/10/2018 | 19/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 404 | EUCTR2017-000574-11-EE (EUCTR) | 03/10/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 405 | EUCTR2017-000617-23-EE (EUCTR) | 03/10/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 983 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 406 | EUCTR2017-004209-41-NL (EUCTR) | 01/10/2018 | 27/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 407 | EUCTR2017-004209-41-BG (EUCTR) | 26/09/2018 | 19/07/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 408 | NCT03606499 (ClinicalTrials.gov) | September 26, 2018 | 20/7/2018 | Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases | Effectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world Setting | Crohn Disease;Colitis, Ulcerative | Drug: Ustekinumab | Janssen Cilag S.A.S. | NULL | Recruiting | 18 Years | N/A | All | 214 | France | |
| 409 | EUCTR2017-003359-43-AT (EUCTR) | 24/09/2018 | 20/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 410 | EUCTR2017-004295-55-DE (EUCTR) | 21/09/2018 | 21/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 411 | JPRN-JapicCTI-183950 | 20/9/2018 | 07/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | Crohn's Disease | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. Control intervention name : Ustekinumab INN of the control intervention : Ustekinumab Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion. | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 2000 | Phase 2-3 | Japan, North America | |
| 412 | EUCTR2017-004294-14-BE (EUCTR) | 20/09/2018 | 28/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 413 | EUCTR2017-000575-88-NL (EUCTR) | 17/09/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | ||
| 414 | EUCTR2017-000617-23-NL (EUCTR) | 17/09/2018 | 17/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 415 | EUCTR2017-000576-29-BG (EUCTR) | 14/09/2018 | 24/07/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 416 | EUCTR2017-000617-23-BG (EUCTR) | 14/09/2018 | 10/07/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 417 | EUCTR2017-001976-48-HU (EUCTR) | 13/09/2018 | 05/07/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS 986165 in Subjects with Moderate-to-Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 144 | Phase 2 | Korea, Republic of;Germany;Denmark;Australia;Romania;Poland;Brazil;Canada;Mexico;Czech Republic;Hungary;France;Italy;Switzerland;United Kingdom;Spain;Taiwan;Portugal;United States | ||
| 418 | EUCTR2017-001226-18-BE (EUCTR) | 13/09/2018 | 02/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | South Africa;Latvia;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 419 | EUCTR2017-001240-35-BE (EUCTR) | 13/09/2018 | 02/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Malaysia;Denmark;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 420 | EUCTR2017-001225-41-BE (EUCTR) | 13/09/2018 | 19/12/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;Czech Republic;Egypt;United Kingdom;Austria;Turkey;Lithuania;Slovenia;Korea, Republic of;Bosnia and Herzegovina;China;Latvia;Netherlands;South Africa;Australia;Denmark;Malaysia;Puerto Rico;Switzerland | ||
| 421 | EUCTR2017-001226-18-CZ (EUCTR) | 12/09/2018 | 19/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | United Kingdom;Egypt;Hungary;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 422 | EUCTR2017-001225-41-CZ (EUCTR) | 12/09/2018 | 20/04/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 423 | EUCTR2017-002195-13-NL (EUCTR) | 10/09/2018 | 30/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Latvia;Netherlands;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 424 | EUCTR2017-004294-14-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Japan;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand | ||
| 425 | EUCTR2017-004292-31-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Israel;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand;United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Switzerland;Italy;France;Puerto Rico | ||
| 426 | EUCTR2017-004292-31-BE (EUCTR) | 10/09/2018 | 23/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 427 | EUCTR2017-004295-55-IE (EUCTR) | 10/09/2018 | 27/04/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland | ||
| 428 | EUCTR2017-002195-13-HR (EUCTR) | 07/09/2018 | 16/05/2019 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 429 | EUCTR2017-004292-31-DE (EUCTR) | 06/09/2018 | 06/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 430 | EUCTR2017-004209-41-IT (EUCTR) | 31/08/2018 | 17/06/2021 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: [CNTO1275] INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Humira® Product Name: Adalimumab Product Code: [Adalimumab] INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 431 | NCT03615378 (ClinicalTrials.gov) | August 30, 2018 | 16/7/2018 | Maintenance Dosing of Vitamin D in Crohn's Disease | A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission | Crohns Disease;Vitamin D Deficiency | Dietary Supplement: 5000 IU D3;Dietary Supplement: 1000 IU D3;Dietary Supplement: Placebo | Cedars-Sinai Medical Center | NULL | Terminated | 18 Years | N/A | All | 10 | Early Phase 1 | United States |
| 432 | EUCTR2017-000576-29-PT (EUCTR) | 27/08/2018 | 01/06/2018 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 433 | EUCTR2017-004209-41-CZ (EUCTR) | 27/08/2018 | 13/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 434 | NCT03452501 (ClinicalTrials.gov) | August 26, 2018 | 26/2/2018 | Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients | An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD | Inflammatory Bowel Diseases;Crohn Disease;Fistulizing Crohn's Disease;Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | NULL | Completed | 18 Years | N/A | All | 157 | Saudi Arabia | |
| 435 | EUCTR2017-004209-41-GB (EUCTR) | 24/08/2018 | 22/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 436 | EUCTR2017-001976-48-GB (EUCTR) | 23/08/2018 | 26/06/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 437 | EUCTR2017-001976-48-PL (EUCTR) | 23/08/2018 | 17/07/2018 | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease - LATTICE | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165 | Bristol-Myers Squibb international Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Taiwan;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Romania;Germany;Japan | ||
| 438 | EUCTR2017-004294-14-DE (EUCTR) | 23/08/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;France;Italy;Ukraine;Greece;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 439 | EUCTR2017-001225-41-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 440 | EUCTR2017-001226-18-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel | ||
| 441 | EUCTR2017-001240-35-BG (EUCTR) | 22/08/2018 | 05/06/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 442 | NCT03467958 (ClinicalTrials.gov) | August 22, 2018 | 12/3/2018 | An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 1200 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil |
| 443 | EUCTR2017-002195-13-PL (EUCTR) | 13/08/2018 | 25/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 444 | EUCTR2017-002195-13-LV (EUCTR) | 10/08/2018 | 21/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 445 | EUCTR2017-004294-14-SE (EUCTR) | 08/08/2018 | 08/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 535 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 446 | EUCTR2017-004295-55-SE (EUCTR) | 08/08/2018 | 08/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 447 | EUCTR2017-004293-33-PT (EUCTR) | 06/08/2018 | 27/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn¿s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn¿s Disease | Moderately to Severely Active Crohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 448 | EUCTR2017-004209-41-PL (EUCTR) | 03/08/2018 | 20/06/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Korea, Republic of;Germany;Netherlands;Bulgaria;Australia;Belgium;Brazil;Poland;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Spain;Czechia;United States;Serbia | ||
| 449 | EUCTR2017-002195-13-ES (EUCTR) | 30/07/2018 | 21/05/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 450 | NCT03196427 (ClinicalTrials.gov) | July 30, 2018 | 20/6/2017 | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc. | Active, not recruiting | 2 Years | 17 Years | All | 80 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 451 | EUCTR2017-004209-41-FR (EUCTR) | 30/07/2018 | 14/06/2018 | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 452 | EUCTR2017-002195-13-GR (EUCTR) | 27/07/2018 | 17/07/2018 | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Portugal;Serbia;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;North Macedonia;Israel;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 453 | EUCTR2017-000576-29-EE (EUCTR) | 25/07/2018 | 11/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 454 | EUCTR2017-000617-23-HU (EUCTR) | 24/07/2018 | 15/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 455 | EUCTR2017-000576-29-HU (EUCTR) | 24/07/2018 | 15/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | ||
| 456 | NCT03449069 (ClinicalTrials.gov) | July 23, 2018 | 22/2/2018 | Pediatric MSC-AFP Sub-study for Crohn's Fistula | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study | Fistula in Ano;Crohn Disease | Drug: MSC-AFP | Mayo Clinic | NULL | Recruiting | 12 Years | 17 Years | All | 5 | Phase 1 | United States |
| 457 | EUCTR2016-003191-50-SE (EUCTR) | 22/07/2018 | 14/09/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 458 | EUCTR2017-003359-43-HR (EUCTR) | 19/07/2018 | 16/05/2019 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease | Moderate To Severe Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 459 | EUCTR2017-003359-43-CZ (EUCTR) | 19/07/2018 | 04/06/2018 | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;United Arab Emirates;Serbia;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 460 | EUCTR2017-001737-85-NL (EUCTR) | 17/07/2018 | 03/04/2018 | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: albendazole (Eskazole) Product Name: albendazole | academic medical centre | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | Netherlands | ||
| 461 | EUCTR2017-000617-23-ES (EUCTR) | 16/07/2018 | 14/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 462 | NCT03599622 (ClinicalTrials.gov) | July 16, 2018 | 11/7/2018 | An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease | Granulomatous Colitis;Crohn's Disease;Crohn's Enteritis;Granulomatous Enteritis | Drug: BMS-986165;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Hong Kong |
| 463 | EUCTR2017-004294-14-GB (EUCTR) | 13/07/2018 | 26/06/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 464 | EUCTR2017-004292-31-GB (EUCTR) | 13/07/2018 | 26/06/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 465 | EUCTR2016-001367-36-IT (EUCTR) | 12/07/2018 | 15/06/2021 | A Study to Assess a New Treatment in Patients with Moderately to Severely Active Crohn's Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Crohn's Disease - NA | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1320 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 466 | EUCTR2017-004295-55-IT (EUCTR) | 12/07/2018 | 22/01/2021 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease - Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: ozanimod Product Code: [RPC1063 equiv to ozanimod HCI] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1350 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 467 | NCT03476317 (ClinicalTrials.gov) | July 12, 2018 | 8/1/2018 | Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Crohn Disease | Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: Fluconazole | Children's Hospital of Philadelphia | University of Pennsylvania;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 6 Years | N/A | All | 10 | Phase 2 | United States |
| 468 | EUCTR2017-000576-29-ES (EUCTR) | 11/07/2018 | 21/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina | ||
| 469 | EUCTR2017-004294-14-IT (EUCTR) | 11/07/2018 | 14/06/2021 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease - Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Ac | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ozanimod Product Code: [RPC1063 equiv. to ozanimod HCI] INN or Proposed INN: Ozanimod hydrochloride Other descriptive name: ozanimod Product Name: ozanimod Product Code: [RPC1063] Other descriptive name: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 470 | EUCTR2018-001546-33-GB (EUCTR) | 11/07/2018 | 14/05/2018 | The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease | IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0 | Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative Colitis MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Flixabi Product Name: Flixabi INN or Proposed INN: Infliximab | University Southampton Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 471 | EUCTR2017-000576-29-SK (EUCTR) | 10/07/2018 | 17/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Japan;Bulgaria;Belgium;Argentina;Canada;Mexico;Hungary;Switzerland;Colombia;Turkey;Ireland;Lebanon;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;United States | ||
| 472 | EUCTR2017-000617-23-SK (EUCTR) | 10/07/2018 | 17/05/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Serbia;United States;Estonia;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 473 | EUCTR2017-004292-31-DK (EUCTR) | 09/07/2018 | 09/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 675 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 474 | EUCTR2016-003123-32-SE (EUCTR) | 09/07/2018 | 08/09/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 475 | EUCTR2017-000617-23-AT (EUCTR) | 06/07/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 476 | EUCTR2017-000575-88-AT (EUCTR) | 06/07/2018 | 19/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Croatia;Romania;Australia;South Africa;Germany;Netherlands;Japan | ||
| 477 | EUCTR2017-001240-35-LT (EUCTR) | 05/07/2018 | 23/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium | ||
| 478 | EUCTR2017-002195-13-DE (EUCTR) | 03/07/2018 | 01/03/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;North Macedonia;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan | ||
| 479 | NCT03662919 (ClinicalTrials.gov) | July 2, 2018 | 6/9/2018 | One-year Persistence to Treatment of Participants Receiving Flixabi or Imraldi: a French Cohort Study | PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study | Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Crohn's Disease;Colitis, Ulcerative | Drug: Infliximab;Drug: Adalimumab | Biogen | NULL | Active, not recruiting | 6 Years | N/A | All | 2274 | France | |
| 480 | NCT03467620 (ClinicalTrials.gov) | July 2018 | 5/3/2018 | Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease | Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study | Crohn Disease;Inflammatory Bowel Diseases;Cannabis | Drug: Cannabidiol;Drug: Placebo oral capsule | University of Illinois at Chicago | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2/Phase 3 | NULL |
| 481 | EUCTR2017-002195-13-LT (EUCTR) | 28/06/2018 | 20/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 482 | EUCTR2017-001225-41-DK (EUCTR) | 27/06/2018 | 07/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 483 | NCT03464097 (ClinicalTrials.gov) | June 27, 2018 | 26/2/2018 | A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 485 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;China;Croatia;Czechia;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Moldova, Republic of;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil |
| 484 | EUCTR2017-000574-11-BE (EUCTR) | 27/06/2018 | 14/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 485 | EUCTR2017-003359-43-SK (EUCTR) | 26/06/2018 | 19/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 486 | EUCTR2017-001226-18-DE (EUCTR) | 26/06/2018 | 09/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 487 | EUCTR2016-002763-34-IT (EUCTR) | 26/06/2018 | 15/06/2021 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn's Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn's Disease - NA | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: Filgotinib | GILEAD SCIENCES INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 488 | EUCTR2017-001240-35-DE (EUCTR) | 26/06/2018 | 28/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 489 | EUCTR2017-001225-41-DE (EUCTR) | 26/06/2018 | 08/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 490 | NCT03559517 (ClinicalTrials.gov) | June 25, 2018 | 9/5/2018 | Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305) | Crohn's Disease | Biological: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 30 | Phase 3 | United States;Australia;Austria;Croatia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom |
| 491 | EUCTR2017-001240-35-DK (EUCTR) | 25/06/2018 | 10/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 492 | NCT03472690 (ClinicalTrials.gov) | June 25, 2018 | 8/3/2018 | QBECO SSI for Clinical and Endoscopic Remission in Moderate to Severe Crohn's Disease | A Phase 2, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of QBECO SSI for the Induction and Maintenance of Clinical and Endoscopic Remission in Subjects With Moderate to Severe Crohn's Disease | Crohn Disease | Biological: QBECO-SSI;Other: Placebo | Qu Biologics Inc. | NULL | Terminated | 18 Years | N/A | All | 20 | Phase 2 | Canada |
| 493 | EUCTR2017-003359-43-HU (EUCTR) | 21/06/2018 | 25/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50mg Product Code: PF-06651600 50mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 494 | EUCTR2017-004209-41-ES (EUCTR) | 21/06/2018 | 21/05/2018 | A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Trade Name: Humira® Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 495 | EUCTR2017-002195-13-CZ (EUCTR) | 19/06/2018 | 20/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 496 | EUCTR2017-004295-55-HR (EUCTR) | 19/06/2018 | 07/12/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 497 | EUCTR2017-004292-31-HR (EUCTR) | 18/06/2018 | 07/12/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 498 | EUCTR2017-002195-13-SK (EUCTR) | 18/06/2018 | 26/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA INN or Proposed INN: ustekinumab Trade Name: STELARA INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden | ||
| 499 | EUCTR2017-004294-14-HR (EUCTR) | 18/06/2018 | 07/12/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 500 | EUCTR2017-002195-13-BE (EUCTR) | 15/06/2018 | 30/03/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 501 | EUCTR2017-000617-23-LT (EUCTR) | 15/06/2018 | 20/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | ||
| 502 | EUCTR2017-000575-88-LT (EUCTR) | 15/06/2018 | 20/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | ||
| 503 | EUCTR2017-001226-18-EE (EUCTR) | 14/06/2018 | 07/05/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 504 | EUCTR2017-001240-35-EE (EUCTR) | 14/06/2018 | 07/05/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Ireland;Israel;Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 505 | NCT03566823 (ClinicalTrials.gov) | June 11, 2018 | 9/5/2018 | Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306) | Crohn's Disease | Biological: Ontamalimab;Other: Placebo | Shire | NULL | Terminated | 16 Years | 80 Years | All | 34 | Phase 3 | New Zealand;Portugal;Slovakia;Spain;Turkey;Ukraine;United States;Mexico;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon |
| 506 | NCT03142321 (ClinicalTrials.gov) | June 8, 2018 | 3/5/2017 | Defining Predictors of RT Response to Vedolizumab in IBD | Defining Predictors of Radiological Transmural Response to Vedolizumab in Small Bowel Crohn's Disease Through Serum Proteomic Biomarkers | Crohn Disease of Small Intestine | Drug: Vedolizumab 300 MG Injection [Entyvio] | Washington University School of Medicine | NULL | Recruiting | 18 Years | N/A | All | 80 | Phase 4 | United States |
| 507 | EUCTR2017-004295-55-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of | ||
| 508 | EUCTR2017-004293-33-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 509 | EUCTR2017-001225-41-LT (EUCTR) | 06/06/2018 | 23/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 510 | EUCTR2017-004292-31-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 511 | EUCTR2017-004294-14-BG (EUCTR) | 06/06/2018 | 20/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 512 | EUCTR2017-001226-18-LT (EUCTR) | 06/06/2018 | 23/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 513 | EUCTR2017-003359-43-IT (EUCTR) | 05/06/2018 | 21/01/2021 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn's Disease - nd | Moderate To Severe Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg Product Code: [PF-06651600 50 mg] INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg Product Code: [PF-06700841 5 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg Product Code: [PF-06700841 25 mg] INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Czech Republic;Hungary;Slovakia;Belgium;Spain;Poland;Croatia;Lithuania;Austria;Germany;Italy | ||
| 514 | EUCTR2017-001226-18-DK (EUCTR) | 28/05/2018 | 16/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 515 | EUCTR2017-002195-13-AT (EUCTR) | 28/05/2018 | 18/04/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand | ||
| 516 | EUCTR2017-003359-43-BE (EUCTR) | 28/05/2018 | 06/03/2019 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;United Arab Emirates;United States;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 517 | EUCTR2017-003359-43-LT (EUCTR) | 24/05/2018 | 17/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 255 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;Australia;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 518 | EUCTR2016-003153-15-BE (EUCTR) | 24/05/2018 | 07/02/2018 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Czechia;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 519 | EUCTR2017-003359-43-PL (EUCTR) | 23/05/2018 | 24/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ritlecitinib 50 mg Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: Brepocitinib 5 mg Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: Brepocitinib 25 mg Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | United States;Serbia;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;Australia;South Africa;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Georgia;Germany | ||
| 520 | EUCTR2017-004295-55-ES (EUCTR) | 23/05/2018 | 01/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand;Mexico;Canada;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic | ||
| 521 | EUCTR2017-004293-33-SE (EUCTR) | 23/05/2018 | 08/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 675 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 522 | EUCTR2017-004295-55-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 523 | EUCTR2017-004294-14-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 524 | EUCTR2017-001226-18-LV (EUCTR) | 21/05/2018 | 07/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 525 | EUCTR2017-004292-31-LV (EUCTR) | 21/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 526 | EUCTR2017-001240-35-NL (EUCTR) | 18/05/2018 | 08/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 527 | EUCTR2017-001225-41-NL (EUCTR) | 18/05/2018 | 08/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 528 | EUCTR2017-001225-41-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 529 | EUCTR2017-004295-55-GB (EUCTR) | 18/05/2018 | 27/06/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 530 | EUCTR2017-001226-18-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 531 | EUCTR2017-001240-35-HU (EUCTR) | 18/05/2018 | 07/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 532 | EUCTR2017-003649-10-GB (EUCTR) | 15/05/2018 | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 533 | EUCTR2017-001225-41-PT (EUCTR) | 14/05/2018 | 19/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden;Korea, Republic of;China;Latvia;Netherlands;South Africa;Australia;Denmark;Malaysia;Puerto Rico;Switzerland;Italy;Colombia;Russian Federation;Chile;Israel;Ireland;Ukraine;Spain;Slovakia;Taiwan;Hong Kong;United States;Serbia;Portugal | ||
| 534 | EUCTR2016-003191-50-HR (EUCTR) | 14/05/2018 | 29/05/2018 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 535 | EUCTR2017-002231-41-NL (EUCTR) | 14/05/2018 | 26/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom;United States;France;Hungary | ||
| 536 | EUCTR2017-001240-35-PT (EUCTR) | 14/05/2018 | 01/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 537 | EUCTR2017-001226-18-PT (EUCTR) | 14/05/2018 | 01/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 625 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 538 | NCT04160325 (ClinicalTrials.gov) | May 14, 2018 | 3/11/2019 | Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery | The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery | Crohn Disease | Dietary Supplement: postoperative 3-month exclusive enteral nutrition;Drug: azathioprine;Other: normal diet | Zhu Weiming | Sixth Affiliated Hospital, Sun Yat-sen University;Sir Run Run Shaw Hospital;The First Affiliated Hospital of Anhui Medical University;Beijing Tsinghua Changgung Hospital | Recruiting | 18 Years | 65 Years | All | 198 | N/A | China |
| 539 | EUCTR2016-003123-32-HR (EUCTR) | 14/05/2018 | 29/05/2018 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 540 | EUCTR2017-001240-35-PL (EUCTR) | 10/05/2018 | 09/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and /or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 541 | EUCTR2017-001226-18-PL (EUCTR) | 10/05/2018 | 12/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 542 | EUCTR2017-004292-31-ES (EUCTR) | 10/05/2018 | 23/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 543 | EUCTR2017-001240-35-ES (EUCTR) | 10/05/2018 | 10/05/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 544 | EUCTR2017-001225-41-ES (EUCTR) | 10/05/2018 | 10/05/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 545 | EUCTR2017-001226-18-ES (EUCTR) | 09/05/2018 | 10/05/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 546 | EUCTR2017-004292-31-IT (EUCTR) | 08/05/2018 | 02/02/2021 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease - Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Acti | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: ozanimod Product Code: [RPC1063] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 675 | Phase 3 | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 547 | EUCTR2016-003123-32-LT (EUCTR) | 07/05/2018 | 23/01/2018 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 548 | EUCTR2016-003179-23-BE (EUCTR) | 07/05/2018 | 16/02/2018 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Germany | ||
| 549 | EUCTR2016-003191-50-LT (EUCTR) | 07/05/2018 | 01/02/2018 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 550 | EUCTR2016-003190-17-HR (EUCTR) | 04/05/2018 | 16/05/2019 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 551 | EUCTR2017-004294-14-CZ (EUCTR) | 03/05/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 552 | EUCTR2017-004292-31-CZ (EUCTR) | 03/05/2018 | 31/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Taiwan;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Puerto Rico;Denmark;Australia;Latvia;China;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 553 | EUCTR2016-002918-43-DK (EUCTR) | 03/05/2018 | 15/02/2018 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 554 | EUCTR2017-003649-10-BE (EUCTR) | 02/05/2018 | 27/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 1 | Spain;Poland;Belgium;Germany;United Kingdom | ||
| 555 | ChiCTR1800015174 | 2018-05-01 | 2018-03-12 | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Effects of Vitamin D supplementation on clinical prognosis for patients with Crohn's disease | Crohn's disease | control group:placebo;Vitamin D:800IU Vitamin D; | Gudangdong General Hospital, Guangdong Academy of Medical Sciences | NULL | Pending | 18 | 75 | Both | control group:32;Vitamin D:32; | China | |
| 556 | EUCTR2017-003649-10-DE (EUCTR) | 30/04/2018 | 07/02/2018 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | ||
| 557 | EUCTR2017-004294-14-GR (EUCTR) | 27/04/2018 | 28/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 558 | EUCTR2017-004295-55-GR (EUCTR) | 27/04/2018 | 01/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 559 | EUCTR2017-004293-33-GR (EUCTR) | 27/04/2018 | 28/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 560 | EUCTR2017-000574-11-HR (EUCTR) | 27/04/2018 | 27/08/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 561 | EUCTR2017-004292-31-PL (EUCTR) | 26/04/2018 | 20/04/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Belarus;United States;Taiwan;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Puerto Rico;Australia;Denmark;Latvia;Moldova, Republic of;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 562 | EUCTR2017-004294-14-PL (EUCTR) | 26/04/2018 | 20/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 563 | EUCTR2017-004293-33-PL (EUCTR) | 26/04/2018 | 19/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Portugal;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 564 | EUCTR2017-004295-55-PL (EUCTR) | 26/04/2018 | 20/03/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Romania;Croatia;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Georgia;Norway;Germany;Japan;New Zealand | ||
| 565 | EUCTR2017-004294-14-ES (EUCTR) | 25/04/2018 | 02/03/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 566 | EUCTR2017-004293-33-ES (EUCTR) | 25/04/2018 | 02/03/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Serbia;Portugal;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 567 | EUCTR2017-003359-43-ES (EUCTR) | 25/04/2018 | 27/04/2018 | A Phase 2a Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn’s Disease | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 As Induction And Open Label Extension Treatment In Subjects With Moderate To Severe Crohn’s Disease | Moderate To Severe Crohn’s Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600-15 Product Name: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 Product Name: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841-15 | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Phase 2 | Serbia;Belarus;United States;United Arab Emirates;Saudi Arabia;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Israel;Switzerland;Italy;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Georgia;Germany;New Zealand | ||
| 568 | EUCTR2016-000522-18-CZ (EUCTR) | 24/04/2018 | 25/04/2018 | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy | Risk stratified randomized controlled trial in paediatric Crohn´s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Azathioprin INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Humira 40 mg injekcní roztok v predplnené injekcní stríkacce Product Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate Product Name: methotrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 569 | EUCTR2017-000574-11-PT (EUCTR) | 23/04/2018 | 22/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 570 | EUCTR2017-000574-11-IT (EUCTR) | 19/04/2018 | 20/01/2021 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: - Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: ontamalimab Trade Name: - Product Name: SHP647 Product Code: [SHP647] INN or Proposed INN: ontamalimab | SHIRE HUMAN GENETIC THERAPIES, INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Czechia;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 571 | EUCTR2017-001240-35-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 572 | EUCTR2017-001226-18-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | South Africa;Latvia;China;Bosnia and Herzegovina;Portugal;United States;Belarus;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 573 | EUCTR2017-001225-41-SK (EUCTR) | 17/04/2018 | 15/11/2017 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 574 | NCT03466411 (ClinicalTrials.gov) | April 13, 2018 | 8/3/2018 | A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 2000 | Phase 2/Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Netherlands;New Zealand;North Macedonia;Poland;Portugal;Puerto Rico;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Ireland;Macedonia, The Former Yugoslav Republic of;Slovenia;South Africa |
| 575 | EUCTR2017-001226-18-IT (EUCTR) | 12/04/2018 | 15/06/2021 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Portugal;Belarus;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Slovenia;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 576 | EUCTR2017-001240-35-IT (EUCTR) | 12/04/2018 | 15/06/2021 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional e/o Biologiche Therapies. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies. - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 577 | EUCTR2017-000574-11-DE (EUCTR) | 10/04/2018 | 25/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 578 | NCT03105102 (ClinicalTrials.gov) | April 9, 2018 | 4/4/2017 | A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease | Crohn's Disease | Drug: Placebo for Risankizumab SC;Drug: Risankizumab IV;Drug: Placebo for Risankizumab IV;Drug: Risankizumab SC;Drug: Risankizumab On-Body Injector (OBI) | AbbVie | NULL | Active, not recruiting | 16 Years | 80 Years | All | 1250 | Phase 3 | Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;United States;American Samoa;Brazil;Hungary;Turkey;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand |
| 579 | EUCTR2017-001225-41-IT (EUCTR) | 05/04/2018 | 17/06/2021 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 - na | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadaticitib Product Name: Upadacitinib Product Code: [ABT-494] INN or Proposed INN: Upadacitinib | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 580 | NCT03417778 (ClinicalTrials.gov) | April 3, 2018 | 25/1/2018 | Study to Evaluate the Pharmacokinetics of Filgotinib in Participants With Impaired Hepatic Function | A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of Filgotinib in Subjects With Impaired Hepatic Function | Rheumatoid Arthritis;Ulcerative Colitis;Crohn's Disease | Drug: Filgotinib | Gilead Sciences | Galapagos NV | Completed | 18 Years | 70 Years | All | 20 | Phase 1 | United States;Germany;New Zealand |
| 581 | NCT03464136 (ClinicalTrials.gov) | March 29, 2018 | 7/3/2018 | Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year | A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn Disease | Biological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg) | Janssen Scientific Affairs, LLC | NULL | Completed | 18 Years | N/A | All | 386 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom |
| 582 | EUCTR2017-001240-35-LV (EUCTR) | 28/03/2018 | 07/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Austria;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Japan;New Zealand;Sweden | ||
| 583 | EUCTR2016-000522-18-GB (EUCTR) | 28/03/2018 | 05/12/2017 | Risk-stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. | Risk Stratified randomised controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy - REDUCE-RISKinCD-PIBD -TRIAL | Paediatric Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40mg/0.4ml pre-filled syringe Product Name: Humira 40mg/0.4ml pre-filled syringe INN or Proposed INN: ADALIMUMAB Other descriptive name: SUB20016 Product Name: Azathioprine INN or Proposed INN: Azathioprine Other descriptive name: Azathioprine INN or Proposed INN: Azathioprine Product Name: Methotrexate INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate Product Name: Mercaptopurine INN or Proposed INN: Mercaptopurine Other descriptive name: 6-Mercaptopurine | PIBD net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 584 | NCT03478956 (ClinicalTrials.gov) | March 27, 2018 | 26/3/2018 | A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Etrolizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 4 Years | 17 Years | All | 24 | Phase 1 | Belgium;Poland;Spain;United Kingdom;Germany;United States |
| 585 | EUCTR2017-001225-41-GB (EUCTR) | 27/03/2018 | 15/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 738 | Phase 3 | Portugal;United States;Serbia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 586 | EUCTR2017-001226-18-GB (EUCTR) | 26/03/2018 | 06/03/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 645 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 587 | EUCTR2017-001240-35-GB (EUCTR) | 26/03/2018 | 06/03/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 588 | EUCTR2017-003017-25-PL (EUCTR) | 23/03/2018 | 19/12/2017 | Clinical Study to Evaluate the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Spain;Poland;Ukraine;Austria;Russian Federation;Germany | ||
| 589 | EUCTR2017-004295-55-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 590 | EUCTR2017-004293-33-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 591 | EUCTR2017-004294-14-AT (EUCTR) | 23/03/2018 | 14/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 592 | NCT03345823 (ClinicalTrials.gov) | March 21, 2018 | 15/11/2017 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433 | Crohn's Disease | Drug: Upadacitinib;Drug: Placebo for Upadacitinib | AbbVie | NULL | Enrolling by invitation | 18 Years | 75 Years | All | 747 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus |
| 593 | NCT03854305 (ClinicalTrials.gov) | March 20, 2018 | 23/2/2019 | Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease | Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's | Crohn's Disease | Drug: PRV-6527;Drug: Placebo | Provention Bio, Inc. | NULL | Completed | 18 Years | 75 Years | All | 93 | Phase 2 | Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine |
| 594 | EUCTR2017-003017-25-DE (EUCTR) | 20/03/2018 | 22/02/2018 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | ||
| 595 | EUCTR2017-002182-21-NL (EUCTR) | 20/03/2018 | 28/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Germany;Netherlands;United Kingdom | ||
| 596 | EUCTR2017-004294-14-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 597 | EUCTR2017-004295-55-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 598 | EUCTR2017-004293-33-SK (EUCTR) | 16/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 599 | EUCTR2016-002918-43-SK (EUCTR) | 16/03/2018 | 15/02/2018 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 600 | EUCTR2017-000574-11-NL (EUCTR) | 15/03/2018 | 02/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 601 | EUCTR2017-001240-35-SE (EUCTR) | 15/03/2018 | 15/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 602 | EUCTR2017-001225-41-SE (EUCTR) | 15/03/2018 | 12/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 603 | EUCTR2017-003017-25-ES (EUCTR) | 14/03/2018 | 15/12/2017 | Clinical Study to Evaluate the Efficacy and Safety of PRV-6527, an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) INN or Proposed INN: TBC Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | ||
| 604 | EUCTR2017-000574-11-IE (EUCTR) | 13/03/2018 | 04/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 605 | EUCTR2017-004295-55-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 606 | EUCTR2017-004293-33-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Portugal;Serbia;United States;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden | ||
| 607 | EUCTR2017-004294-14-LT (EUCTR) | 12/03/2018 | 01/02/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Russian Federation;Israel;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 608 | EUCTR2017-001226-18-SE (EUCTR) | 12/03/2018 | 16/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 609 | EUCTR2017-001240-35-AT (EUCTR) | 12/03/2018 | 28/02/2018 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | Portugal;United States;Serbia;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 610 | EUCTR2017-001226-18-AT (EUCTR) | 12/03/2018 | 28/02/2018 | A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 645 | Phase 3 | Portugal;Serbia;United States;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 611 | EUCTR2017-001225-41-LV (EUCTR) | 09/03/2018 | 14/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 612 | EUCTR2017-004295-55-HU (EUCTR) | 08/03/2018 | 30/01/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 613 | NCT03440385 (ClinicalTrials.gov) | March 7, 2018 | 14/2/2018 | Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;China;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Korea, Republic of;Lithuania;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;Brazil |
| 614 | NCT03709628 (ClinicalTrials.gov) | March 7, 2018 | 11/4/2018 | A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients | Crohn Disease | Drug: EB8018 (First-in-class FimH blocker) | Enterome | NULL | Completed | 18 Years | N/A | All | 8 | Phase 1 | Austria;France;Germany;Italy |
| 615 | EUCTR2017-004293-33-HU (EUCTR) | 06/03/2018 | 29/01/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Serbia;Portugal;Saudi Arabia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Bulgaria;Georgia;Germany;Sweden | ||
| 616 | EUCTR2017-000574-11-GB (EUCTR) | 06/03/2018 | 21/09/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 617 | EUCTR2017-004294-14-HU (EUCTR) | 06/03/2018 | 30/01/2018 | Multicenter Study of Oral Ozanimod as Maintenance Therapy in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 485 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Georgia;Germany;Norway;Japan;New Zealand | ||
| 618 | JPRN-jRCTs021200013 | 28/02/2018 | 31/07/2020 | A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease. | A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST | Crohn's disease Crohn's disease;D003424 | Ustekinumab monotherapy for 32 weeks. | Moroi Rintao | NULL | Recruiting | >= 18age old | <= 75age old | Both | 80 | Phase 3 | Japan |
| 619 | NCT03283085 (ClinicalTrials.gov) | February 27, 2018 | 12/9/2017 | A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) | Crohn's Disease;Ulcerative Colitis | Drug: 25 mg Ontamalimab;Drug: 75 mg Ontamalimab | Shire | NULL | Recruiting | 16 Years | 80 Years | All | 451 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 620 | NCT03221166 (ClinicalTrials.gov) | February 27, 2018 | 5/7/2017 | Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors | Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network | Crohn Disease | Drug: Thalidomide;Drug: Infliximab | IRCCS Burlo Garofolo | Centro di Riferimento Oncologico - Aviano;Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Terminated | 6 Years | 17 Years | All | 9 | Phase 3 | Italy |
| 621 | NCT03440372 (ClinicalTrials.gov) | February 27, 2018 | 14/2/2018 | Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ozanimod;Other: Placebo | Celgene | NULL | Recruiting | 18 Years | 75 Years | All | 600 | Phase 3 | United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Moldova, Republic of;Norway;Poland;Romania;Russian Federation;Saudi Arabia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil |
| 622 | NCT03801928 (ClinicalTrials.gov) | February 23, 2018 | 11/12/2018 | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Drug: Inflectra | Pfizer | NULL | Completed | 18 Years | N/A | All | 118 | United States;Canada | |
| 623 | EUCTR2016-003179-23-AT (EUCTR) | 19/02/2018 | 16/02/2018 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 624 | EUCTR2017-001225-41-AT (EUCTR) | 19/02/2018 | 07/02/2018 | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | A Multicenter, Randomized, Double-Blind, Placebo- Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 | Crohn's Disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 747 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Bosnia and Herzegovina;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 625 | EUCTR2016-003153-15-AT (EUCTR) | 19/02/2018 | 06/02/2018 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Spain;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 626 | NCT03351647 (ClinicalTrials.gov) | February 14, 2018 | 30/10/2017 | Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease | Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies | Crohn Disease | Biological: Evaluation of biological predictive factors of clinical response to ustekinumab | Hospices Civils de Lyon | NULL | Unknown status | 18 Years | 18 Years | All | 50 | France | |
| 627 | EUCTR2017-003017-25-AT (EUCTR) | 06/02/2018 | 11/12/2017 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | ||
| 628 | EUCTR2016-003191-50-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 629 | EUCTR2016-003123-32-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 630 | EUCTR2016-003190-17-IE (EUCTR) | 06/02/2018 | 25/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 631 | NCT03358706 (ClinicalTrials.gov) | February 2, 2018 | 27/11/2017 | A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis | A Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis. | Crohn Disease;Ulcerative Colitis | Drug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mg | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 57 | Phase 1 | United States;Belgium;Germany;United Kingdom;Austria;Denmark;Sweden |
| 632 | NCT03395184 (ClinicalTrials.gov) | February 2, 2018 | 5/12/2017 | Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease | A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE | Crohn's Disease | Drug: PF-06651600 Placebo;Drug: PF-06651600;Drug: Placebo PF-06700841;Drug: PF-06700841 | Pfizer | NULL | Recruiting | 18 Years | 75 Years | All | 250 | Phase 2 | United States;Australia;Austria;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Georgia;Germany;Hungary;Italy;Korea, Republic of;Lebanon;Poland;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Turkey;Ukraine;United Arab Emirates |
| 633 | EUCTR2016-003191-50-BE (EUCTR) | 01/02/2018 | 14/02/2018 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 634 | EUCTR2016-003123-32-BE (EUCTR) | 01/02/2018 | 08/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 635 | EUCTR2016-003190-17-BE (EUCTR) | 01/02/2018 | 14/02/2018 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Brazil;Belgium;Singapore;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 636 | NCT03185000 (ClinicalTrials.gov) | February 2018 | 13/4/2017 | Treg Immunotherapy in Crohn's Disease | A Double-blind, Placebo Controlled, First Into Human Clinical Trial of T Regulatory Cells (TR004) for Inflammatory Bowel Disease Using (ex Vivo) Treg Expansion | Crohn Disease | Drug: TR004 (Treg immunotherapy);Other: Placebo | King's College London | Guy's and St Thomas' NHS Foundation Trust;Medical Research Council;Imperial College London;St. George's Hospital, London;Miltenyi biotech | Not yet recruiting | 18 Years | 80 Years | All | 24 | Phase 1/Phase 2 | NULL |
| 637 | EUCTR2017-000574-11-LT (EUCTR) | 30/01/2018 | 31/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;United States;Portugal;Serbia;Estonia;Slovakia | ||
| 638 | EUCTR2017-000574-11-HU (EUCTR) | 23/01/2018 | 27/10/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 639 | EUCTR2017-002231-41-PL (EUCTR) | 17/01/2018 | 13/10/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 640 | EUCTR2017-002182-21-PL (EUCTR) | 17/01/2018 | 13/10/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 641 | EUCTR2016-003190-17-GR (EUCTR) | 16/01/2018 | 15/11/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 642 | EUCTR2016-003123-32-GR (EUCTR) | 16/01/2018 | 08/11/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 940 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 643 | EUCTR2016-003191-50-GR (EUCTR) | 16/01/2018 | 16/11/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | France;Puerto Rico;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 644 | NCT03901235 (ClinicalTrials.gov) | January 15, 2018 | 4/3/2019 | MSC Intratissular Injection in Crohn Disease Patients | Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells | Efficacy and Safety | Biological: Mesenchymal Stromal Cells | University of Liege | Centre Hospitalier Universitaire de Liege | Recruiting | 18 Years | N/A | All | 60 | Phase 1/Phase 2 | Belgium |
| 645 | EUCTR2016-003191-50-NL (EUCTR) | 15/01/2018 | 08/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Serbia;United States;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Korea, Republic of;Bosnia and Herzegovina;Latvia;Denmark;Puerto Rico;France;Italy;Chile;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Belarus;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 646 | EUCTR2017-002182-21-BE (EUCTR) | 10/01/2018 | 14/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 647 | EUCTR2017-002231-41-BE (EUCTR) | 10/01/2018 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 648 | EUCTR2016-003191-50-DE (EUCTR) | 09/01/2018 | 20/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan;Serbia;United States;Sweden;Romania;Croatia;Brazil;Canada;Mexico;Czech Republic;Korea, Republic of;Bosnia and Herzegovina;Latvia;Denmark;Puerto Rico;France;Italy;Chile;Ukraine;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Belarus | ||
| 649 | EUCTR2016-003190-17-DE (EUCTR) | 09/01/2018 | 19/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 650 | EUCTR2016-003123-32-DE (EUCTR) | 09/01/2018 | 19/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 651 | EUCTR2017-003017-25-HU (EUCTR) | 08/01/2018 | 13/11/2017 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527(JNJ-40346527) Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | ||
| 652 | EUCTR2017-000574-11-BG (EUCTR) | 04/01/2018 | 24/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Israel;Russian Federation;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil | ||
| 653 | EUCTR2016-003190-17-LT (EUCTR) | 29/12/2017 | 17/10/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 654 | EUCTR2016-000522-18-NL (EUCTR) | 28/12/2017 | 03/07/2017 | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively - a treatment strategy. - REDUCE-RISKincd-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: humira INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine Product Name: imuran INN or Proposed INN: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: methotrexate Product Name: methotrexate Product Code: L01BA INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBDNet | NULL | Not Recruiting | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Canada;Poland;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 655 | EUCTR2017-000574-11-AT (EUCTR) | 22/12/2017 | 30/10/2017 | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 656 | EUCTR2016-003179-23-DE (EUCTR) | 19/12/2017 | 14/02/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 657 | EUCTR2017-002182-21-FR (EUCTR) | 18/12/2017 | 15/12/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 658 | EUCTR2017-002182-21-DE (EUCTR) | 18/12/2017 | 13/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 659 | NCT03104413 (ClinicalTrials.gov) | December 18, 2017 | 4/4/2017 | A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's Disease | Drug: placebo for risankizumab IV;Drug: risankizumab SC;Drug: risankizumab IV | AbbVie | NULL | Completed | 16 Years | 80 Years | All | 618 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom;American Samoa;Brazil;Hungary;Turkey |
| 660 | EUCTR2017-002231-41-DE (EUCTR) | 18/12/2017 | 14/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 661 | EUCTR2017-000574-11-SK (EUCTR) | 13/12/2017 | 21/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2453 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 662 | NCT03345849 (ClinicalTrials.gov) | December 7, 2017 | 15/11/2017 | A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies | Crohn's Disease | Drug: Upadacitinib;Drug: Placebo for Upadacitinib | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 524 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Belarus |
| 663 | NCT02974322 (ClinicalTrials.gov) | December 1, 2017 | 23/11/2016 | A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Withdrawn | 12 Years | N/A | All | 0 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic |
| 664 | NCT03345836 (ClinicalTrials.gov) | November 29, 2017 | 15/11/2017 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy | Crohn's Disease | Other: Matching placebo for upadacitinib;Drug: upadacitinib | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 625 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;American Samoa;Belarus;Ukraine |
| 665 | NCT02559713 (ClinicalTrials.gov) | November 29, 2017 | 23/9/2015 | Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease | An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | Female | 11 | Phase 4 | United States |
| 666 | EUCTR2016-003191-50-GB (EUCTR) | 28/11/2017 | 24/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 667 | EUCTR2016-003153-15-DE (EUCTR) | 28/11/2017 | 13/04/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 668 | EUCTR2016-003123-32-GB (EUCTR) | 28/11/2017 | 20/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 669 | EUCTR2016-003190-17-GB (EUCTR) | 28/11/2017 | 20/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Belarus;Portugal;Hong Kong;Taiwan | ||
| 670 | NCT03362736 (ClinicalTrials.gov) | November 27, 2017 | 30/11/2017 | An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease | An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | NULL | No longer available | 18 Years | N/A | All | Brazil | ||
| 671 | NCT03261206 (ClinicalTrials.gov) | November 20, 2017 | 22/8/2017 | Stopping Aminosalicylate Therapy in Inactive Crohn's Disease | Stopping Aminosalicylate Therapy in Inactive Crohn's Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial | Crohn Disease;Remission | Other: 5-ASA Withdrawal | Alimentiv Inc. | Academic Medical Organization of Southwestern Ontario | Recruiting | 18 Years | N/A | All | 1580 | Phase 4 | Canada;Italy;Ukraine;United Kingdom |
| 672 | EUCTR2017-002182-21-GB (EUCTR) | 16/11/2017 | 11/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 673 | NCT03537157 (ClinicalTrials.gov) | November 16, 2017 | 15/5/2018 | A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention | A Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease Recurrence | Crohn Disease | Drug: Rifaximin delayed release tablets;Other: Placebo | Alfasigma S.p.A. | Cromsource | Terminated | 18 Years | 75 Years | All | 43 | Phase 2 | Italy |
| 674 | EUCTR2017-002231-41-GB (EUCTR) | 15/11/2017 | 11/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 675 | EUCTR2016-003179-23-IT (EUCTR) | 14/11/2017 | 12/02/2021 | This trial will test the drug filgotinib for the treatment of small bowel Crohn¿s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn¿s Disease (SBCD) - na | Small Bowel Crohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: [GS-6034] INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Czechia;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 676 | EUCTR2016-003190-17-EE (EUCTR) | 13/11/2017 | 30/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 677 | EUCTR2016-003190-17-BG (EUCTR) | 08/11/2017 | 28/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 678 | EUCTR2016-003123-32-BG (EUCTR) | 08/11/2017 | 28/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 679 | EUCTR2016-003191-50-BG (EUCTR) | 08/11/2017 | 27/07/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 680 | NCT03138655 (ClinicalTrials.gov) | November 8, 2017 | 19/4/2017 | Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Takeda Development Center Americas, Inc.;Takeda Development Centre Europe Ltd. | Completed | 2 Years | 17 Years | All | 90 | Phase 2 | United States;Belgium;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom |
| 681 | EUCTR2016-003190-17-NL (EUCTR) | 07/11/2017 | 10/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;New Zealand;Norway;Germany;Bulgaria | ||
| 682 | EUCTR2016-002763-34-NL (EUCTR) | 06/11/2017 | 14/08/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 683 | EUCTR2017-002545-30-GB (EUCTR) | 06/11/2017 | 07/06/2018 | Controlled trial to assess low intensity autologous stem cell transplant in refractory Crohn's Disease | Autologous Stem cell Transplantation In refractory Crohn's disease - Low Intensity Therapy Evaluation - ASTIClite | Refractory Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Trade Name: Filgrastim Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Fludarabine Product Name: Fludarabine INN or Proposed INN: Fludarabine phosphate Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin | Barts Health NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 99 | Phase 3 | United Kingdom | ||
| 684 | NCT03357471 (ClinicalTrials.gov) | November 3, 2017 | 23/11/2017 | Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease | Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease | Drug: e-Device | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 70 | Phase 3 | United States |
| 685 | NCT03167437 (ClinicalTrials.gov) | October 30, 2017 | 24/5/2017 | An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab | An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease and Maintenance Therapy With Ustekinumab | Crohn's Disease | Drug: Vorinostat;Drug: Ustekinumab | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Recruiting | 18 Years | 65 Years | All | 35 | Phase 1/Phase 2 | United States |
| 686 | EUCTR2017-002182-21-HU (EUCTR) | 25/10/2017 | 12/09/2017 | An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease.(Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis orCrohn’s Disease) - Hubble Zoom | Ulcerative Colitis or Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 687 | EUCTR2016-003191-50-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 688 | EUCTR2017-002231-41-HU (EUCTR) | 25/10/2017 | 19/09/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | ||
| 689 | EUCTR2016-003123-32-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 940 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 690 | EUCTR2016-003190-17-ES (EUCTR) | 25/10/2017 | 20/10/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 691 | NCT03495973 (ClinicalTrials.gov) | October 25, 2017 | 28/3/2018 | Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease | Prospective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE) | Crohn Disease | Drug: Ustekinumab | Janssen-Cilag Ltd. | NULL | Completed | 18 Years | N/A | All | 114 | Sweden | |
| 692 | NCT03171246 (ClinicalTrials.gov) | October 23, 2017 | 17/5/2017 | CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease | An Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's Disease | Crohn Disease | Dietary Supplement: Solid food-based intervention | NHS Greater Glasgow and Clyde | University of Glasgow | Unknown status | 6 Years | 65 Years | All | 20 | N/A | United Kingdom |
| 693 | NCT03220243 (ClinicalTrials.gov) | October 19, 2017 | 14/7/2017 | Stem Cell Coated Fistula Plug in Patients With Crohn's RVF | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Rectovaginal Fistulizing Crohn's Disease | Fistula Vagina;Crohn Disease | Drug: MSC-AFP | Mayo Clinic | NULL | Completed | 18 Years | 65 Years | Female | 5 | Phase 1 | United States |
| 694 | EUCTR2015-000555-24-IT (EUCTR) | 16/10/2017 | 18/06/2021 | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel. | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: [MLN0002] INN or Proposed INN: vedolizumab | AMC MEDICAL RESEARCH B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | France;Spain;Netherlands;Italy | ||
| 695 | EUCTR2015-001924-40-HR (EUCTR) | 13/10/2017 | 02/11/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 696 | EUCTR2014-005376-29-HU (EUCTR) | 13/10/2017 | 30/08/2017 | An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's disease | An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Hungary;Belgium;Netherlands | ||
| 697 | EUCTR2016-003123-32-EE (EUCTR) | 10/10/2017 | 28/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 698 | EUCTR2016-003191-50-EE (EUCTR) | 10/10/2017 | 10/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 699 | NCT03194529 (ClinicalTrials.gov) | October 9, 2017 | 19/6/2017 | FMT in Pediatric Crohn's Disease | Safety of FMT in Maintenance of Pediatric Crohn's Disease | Crohn Disease;Pediatric Crohns Disease | Biological: FMT | Children's Hospital Los Angeles | NULL | Completed | 7 Years | 21 Years | All | 9 | Phase 1/Phase 2 | United States |
| 700 | EUCTR2016-002918-43-PT (EUCTR) | 09/10/2017 | 11/08/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | France;Portugal;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 701 | EUCTR2016-003190-17-CZ (EUCTR) | 02/10/2017 | 19/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 702 | EUCTR2016-003191-50-IT (EUCTR) | 19/09/2017 | 06/09/2021 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991 - na | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 912 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 703 | EUCTR2016-003123-32-IT (EUCTR) | 19/09/2017 | 09/09/2021 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease - na | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Other descriptive name: na Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 940 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 704 | EUCTR2016-003190-17-IT (EUCTR) | 19/09/2017 | 01/10/2021 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment - not applicable | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 705 | EUCTR2016-003123-32-SK (EUCTR) | 15/09/2017 | 23/05/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rizankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 940 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 706 | NCT03279081 (ClinicalTrials.gov) | September 15, 2017 | 21/7/2017 | Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) | A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks | Crohn's Disease | Drug: Cx601;Other: Placebo | Tigenix S.A.U. | NULL | Recruiting | 18 Years | N/A | All | 554 | Phase 3 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Puerto Rico;Spain;Sweden;United Kingdom |
| 707 | EUCTR2016-003191-50-CZ (EUCTR) | 13/09/2017 | 21/07/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Bulgaria;Germany;Norway;Japan;New Zealand;Singapore;Poland;Belgium;Argentina;Hungary;Egypt;United Kingdom;Austria;Lithuania;Czechia;Netherlands;South Africa;Australia;Malaysia;Switzerland;Colombia;Russian Federation;Israel;Ireland;Spain;Estonia;United States;Serbia;Sweden | ||
| 708 | JPRN-JapicCTI-184152 | 01/9/2017 | 11/10/2018 | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease | Crohn's disease | Intervention name : Budesonide ( Zentacort Capsules 3mg ) INN of the intervention : Budesonide Dosage And administration of the intervention : Oral | ZERIA Pharmaceutical Co., Ltd. | NULL | recruiting | BOTH | 200 | NA | NULL | ||
| 709 | NCT02872506 (ClinicalTrials.gov) | September 2017 | 16/8/2016 | Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection | Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection | Quality of Life | Drug: Anti TNF;Procedure: ileocecal resection | University Hospital, Lille | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | NULL |
| 710 | EUCTR2016-003123-32-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 711 | EUCTR2016-003190-17-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 712 | EUCTR2016-003191-50-PT (EUCTR) | 28/08/2017 | 21/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 713 | EUCTR2016-003190-17-AT (EUCTR) | 25/08/2017 | 31/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 714 | EUCTR2016-003123-32-AT (EUCTR) | 25/08/2017 | 31/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 715 | EUCTR2016-003190-17-SK (EUCTR) | 23/08/2017 | 24/05/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rizankisumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankisumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankisumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Rizankisumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 716 | ChiCTR-INR-17012532 | 2017-08-23 | 2017-09-01 | The use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's disease | The use of indocyanine green fluorescent angiography to guide the surgical treatment of Crohn's disease: a single-center randomized single-blind cohort study | Crohn's disease | Intervention group:Indocyanine green fluorescent angiography;control group:Physiological saline; | Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 | 70 | Both | Intervention group:40;control group:40; | China | |
| 717 | EUCTR2016-003191-50-SK (EUCTR) | 23/08/2017 | 31/05/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 718 | EUCTR2016-003153-15-CZ (EUCTR) | 21/08/2017 | 13/04/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Belgium;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 719 | EUCTR2016-003191-50-LV (EUCTR) | 18/08/2017 | 25/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; ; or Completed M15-989 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 959 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 720 | EUCTR2016-003191-50-AT (EUCTR) | 03/08/2017 | 31/07/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Japan;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 721 | NCT03234907 (ClinicalTrials.gov) | August 3, 2017 | 26/7/2017 | Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Vedolizumab IV;Drug: Placebo | Takeda | NULL | Completed | 18 Years | 80 Years | All | 215 | Phase 3 | China |
| 722 | EUCTR2016-003153-15-GB (EUCTR) | 01/08/2017 | 10/04/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Czechia;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany | ||
| 723 | EUCTR2016-003123-32-LV (EUCTR) | 31/07/2017 | 01/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 940 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 724 | EUCTR2016-003190-17-LV (EUCTR) | 31/07/2017 | 01/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Slovenia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand | ||
| 725 | EUCTR2015-000852-12-BE (EUCTR) | 31/07/2017 | 24/03/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 18.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 4 | France;United States;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 726 | EUCTR2016-003190-17-DK (EUCTR) | 25/07/2017 | 19/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 727 | NCT03185624 (ClinicalTrials.gov) | July 25, 2017 | 11/6/2017 | Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease | Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial | Crohn Disease | Drug: Rifaximin | Sixth Affiliated Hospital, Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw Hospital | Not yet recruiting | 18 Years | 65 Years | All | 80 | Phase 3 | China |
| 728 | EUCTR2016-003191-50-DK (EUCTR) | 19/07/2017 | 18/07/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan | ||
| 729 | EUCTR2015-000609-38-GB (EUCTR) | 17/07/2017 | 10/05/2018 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 730 | EUCTR2016-003153-15-IT (EUCTR) | 17/07/2017 | 20/11/2020 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn¿s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn¿s Disease - This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as | Perianal Fistulizing Crohn¿s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Czechia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany | ||
| 731 | NCT03169894 (ClinicalTrials.gov) | July 14, 2017 | 24/5/2017 | Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease | Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFa Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFa-Resistant Crohn's Disease [TRaCk LIGHT]) | Crohn Disease | Drug: MDGN-002 | Aevi Genomic Medicine, LLC, a Cerecor company | NULL | Recruiting | 18 Years | 75 Years | All | 8 | Phase 1 | United States |
| 732 | NCT03219359 (ClinicalTrials.gov) | July 12, 2017 | 13/7/2017 | Autologous Stem Cell Transplant for Crohn's Disease | Maintenance in Autologous Stem Cell Transplant for Crohn's Disease (MASCT - CD) | Crohn Disease | Procedure: Autologous stem cell transplant;Drug: Cyclophosphamide;Drug: Thymoglobulin;Drug: Methylprednisolone;Drug: Vedolizumab | Icahn School of Medicine at Mount Sinai | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 733 | EUCTR2016-001956-22-DE (EUCTR) | 04/07/2017 | 28/10/2016 | A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease | A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 1 | France;United States;Canada;Poland;Belgium;Germany | ||
| 734 | EUCTR2016-002918-43-DE (EUCTR) | 03/07/2017 | 13/02/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 735 | NCT03014219 (ClinicalTrials.gov) | July 2017 | 4/1/2017 | Phase 1 Crohn's Pediatric Sub-study of MSC AFP | A Phase I Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease: Pediatric Sub-study | Perianal Fistula | Drug: Only 1 arm: treatment with MSC-AFP | William A. Faubion, M.D. | NULL | Withdrawn | 12 Years | 17 Years | All | 0 | Phase 1 | United States |
| 736 | EUCTR2015-001924-40-PT (EUCTR) | 26/06/2017 | 01/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 737 | EUCTR2016-002763-34-HR (EUCTR) | 26/06/2017 | 12/09/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 738 | JPRN-jRCTs041180126 | 17/06/2017 | 23/03/2019 | CD Alfacalcidol study | The study of effect of Alfacalcidol treatment on Crohn's disease | Crohn's disease | administration of alfacalcidol for patietns with active lesion of small intestine by CE and low 25OHD level. | Nakamura Masanao | NULL | Recruiting | >= 18age old | Not applicable | Both | 36 | Phase 2 | Japan |
| 739 | NCT03267238 (ClinicalTrials.gov) | June 16, 2017 | 24/7/2017 | Fecal Microbial Transplantation in Patients With Crohn's Disease | Fecal Microbial Transplantation in Patients With Crohn's Disease | Crohn Disease | Biological: Fecal Microbial Transplantation | Stony Brook University | NULL | Completed | 7 Years | N/A | All | 9 | Early Phase 1 | United States |
| 740 | NCT03235180 (ClinicalTrials.gov) | June 16, 2017 | 27/7/2017 | Ultrasound Evaluation of Crohn's Disease | Ultrasound Evaluation of Crohn's Disease | Crohn Disease | Drug: Sulfur Hexafluoride;Device: Ultrasound Elastography;Device: Ultrasound Vascularity;Device: Magnetic Resonance Enterography (MRE) | Mayo Clinic | NULL | Enrolling by invitation | 18 Years | N/A | All | 100 | Phase 4 | United States |
| 741 | EUCTR2015-001924-40-BE (EUCTR) | 14/06/2017 | 06/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden;Netherlands;Latvia;Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark | ||
| 742 | EUCTR2016-002918-43-NL (EUCTR) | 14/06/2017 | 02/03/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 743 | EUCTR2015-001924-40-IT (EUCTR) | 12/06/2017 | 23/02/2018 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Other descriptive name: GED-0301 Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Other descriptive name: GED-0301 | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 744 | NCT02764762 (ClinicalTrials.gov) | June 12, 2017 | 5/5/2016 | Triple Combination Therapy in High Risk Crohn's Disease (CD) | An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications | Crohn Disease | Drug: Vedolizumab;Drug: Adalimumab;Drug: Methotrexate | Takeda | NULL | Active, not recruiting | 18 Years | 65 Years | All | 55 | Phase 4 | United States;Canada |
| 745 | EUCTR2016-003153-15-HU (EUCTR) | 08/06/2017 | 13/04/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 19.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;France;Czech Republic;Hungary;Canada;Belgium;Spain;Poland;Austria;Germany;United Kingdom;Italy | ||
| 746 | EUCTR2016-003153-15-PL (EUCTR) | 07/06/2017 | 19/04/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy;United Kingdom | ||
| 747 | EUCTR2015-003759-23-CZ (EUCTR) | 01/06/2017 | 30/06/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 748 | EUCTR2016-002763-34-SE (EUCTR) | 24/05/2017 | 27/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 749 | NCT03185611 (ClinicalTrials.gov) | May 18, 2017 | 11/6/2017 | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease | Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial | Crohn Disease | Drug: Rifaximin;Drug: Azathioprine | Sixth Affiliated Hospital, Sun Yat-sen University | First Affiliated Hospital, Sun Yat-Sen University;Peking Union Medical College Hospital;Xijing Hospital;Shanghai 10th People's Hospital;RenJi Hospital;Sir Run Run Shaw Hospital | Recruiting | 18 Years | 65 Years | All | 120 | Phase 3 | China |
| 750 | NCT03155945 (ClinicalTrials.gov) | May 18, 2017 | 11/5/2017 | Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain | A Randomized, Open-label, Parallel, Phase 2a Study to Determine the Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain | Crohn's Disease;Abdominal Pain | Drug: APD371 | Arena Pharmaceuticals | NULL | Completed | 18 Years | 80 Years | All | 14 | Phase 2 | United States |
| 751 | EUCTR2015-001924-40-GB (EUCTR) | 17/05/2017 | 27/01/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 752 | EUCTR2016-002918-43-FR (EUCTR) | 16/05/2017 | 16/05/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Sweden;Italy;United Kingdom;Germany;Netherlands;Denmark;Belgium;Spain;Slovakia;France;Portugal | ||
| 753 | NCT03105128 (ClinicalTrials.gov) | May 10, 2017 | 4/4/2017 | A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: placebo for risankizumab;Drug: risankizumab IV;Drug: risankizumab SC | AbbVie | NULL | Completed | 16 Years | 80 Years | All | 931 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hong Kong;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Finland;France;Hungary;Turkey |
| 754 | EUCTR2016-000612-14-HR (EUCTR) | 10/05/2017 | 07/06/2017 | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity | Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Belarus;Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 755 | EUCTR2016-002763-34-IS (EUCTR) | 09/05/2017 | 27/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 756 | EUCTR2016-002763-34-GR (EUCTR) | 05/05/2017 | 03/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 757 | EUCTR2015-001924-40-GR (EUCTR) | 05/05/2017 | 20/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 758 | EUCTR2016-003153-15-ES (EUCTR) | 03/05/2017 | 04/05/2017 | This trial will test the drug filgotinib for the treatment of fistulas around the anus (perianal) as a complication of Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease | Perianal Fistulizing Crohn’s Disease MedDRA version: 19.1;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 759 | NCT03172377 (ClinicalTrials.gov) | May 3, 2017 | 29/5/2017 | Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients | Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients | Crohn Disease in Remission;Crohn Disease | Other: Lengthening adalimumab dosing interval | Radboud University | Erasmus Medical Center | Active, not recruiting | 18 Years | N/A | All | 174 | Phase 4 | Netherlands |
| 760 | EUCTR2016-002204-84-BE (EUCTR) | 02/05/2017 | 06/02/2017 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 761 | EUCTR2016-002204-84-PL (EUCTR) | 27/04/2017 | 20/01/2017 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 762 | EUCTR2016-003179-23-PL (EUCTR) | 27/04/2017 | 01/03/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Germany | ||
| 763 | EUCTR2016-003179-23-HU (EUCTR) | 26/04/2017 | 06/03/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 764 | EUCTR2016-002204-84-NL (EUCTR) | 25/04/2017 | 08/12/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 765 | EUCTR2015-001924-40-NL (EUCTR) | 24/04/2017 | 08/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Latvia;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 766 | NCT02994836 (ClinicalTrials.gov) | April 21, 2017 | 24/10/2016 | GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) | Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation | Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Active, not recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain |
| 767 | EUCTR2015-001924-40-FR (EUCTR) | 20/04/2017 | 27/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 768 | NCT03107793 (ClinicalTrials.gov) | April 19, 2017 | 28/3/2017 | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab | Crohn Disease | Drug: Ustekinumab | Janssen-Cilag Ltd. | NULL | Completed | 18 Years | N/A | All | 500 | Phase 3 | Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom |
| 769 | EUCTR2016-002939-15-NL (EUCTR) | 18/04/2017 | 22/02/2017 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Netherlands;Germany;Norway | ||
| 770 | EUCTR2016-003179-23-GB (EUCTR) | 13/04/2017 | 09/02/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 771 | EUCTR2015-001924-40-DE (EUCTR) | 12/04/2017 | 06/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 772 | NCT03046056 (ClinicalTrials.gov) | April 11, 2017 | 6/2/2017 | Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) | Small Bowel Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Completed | 18 Years | 75 Years | All | 78 | Phase 2 | United States;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Spain;Ukraine;United Kingdom;Israel |
| 773 | EUCTR2015-001924-40-HU (EUCTR) | 07/04/2017 | 09/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 774 | EUCTR2015-001924-40-ES (EUCTR) | 07/04/2017 | 10/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 775 | EUCTR2015-003759-23-HU (EUCTR) | 07/04/2017 | 28/02/2017 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 776 | NCT03077412 (ClinicalTrials.gov) | April 6, 2017 | 8/3/2017 | Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease | Fistulizing Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States;Austria;Belgium;Canada;France;Germany;Hungary;Italy;United Kingdom;Czechia;Israel;Poland;Spain |
| 777 | EUCTR2016-003179-23-CZ (EUCTR) | 06/04/2017 | 15/02/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Spain;Ukraine;Austria;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 778 | EUCTR2016-002939-15-DE (EUCTR) | 05/04/2017 | 02/11/2016 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Norway;Netherlands;Germany;Poland;Belgium;Canada;Hungary;Czech Republic;United Kingdom;Austria;Ukraine;Slovakia;United States | ||
| 779 | EUCTR2016-003179-23-FR (EUCTR) | 04/04/2017 | 04/04/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Italy;United States;Spain;Ukraine;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany | ||
| 780 | EUCTR2015-001924-40-DK (EUCTR) | 04/04/2017 | 07/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 781 | EUCTR2016-002918-43-BE (EUCTR) | 03/04/2017 | 02/02/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 782 | EUCTR2015-001924-40-LV (EUCTR) | 31/03/2017 | 02/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 783 | EUCTR2016-002763-34-BE (EUCTR) | 31/03/2017 | 08/08/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 784 | EUCTR2016-000612-14-GR (EUCTR) | 31/03/2017 | 02/02/2017 | BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, non-inferiority trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | Moderately to severely active Crohn’s disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 286 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 785 | EUCTR2015-001924-40-FI (EUCTR) | 30/03/2017 | 28/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 786 | EUCTR2015-001963-37-FI (EUCTR) | 30/03/2017 | 23/02/2017 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 787 | EUCTR2016-002939-15-HU (EUCTR) | 29/03/2017 | 06/01/2017 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Germany;Netherlands;Norway | ||
| 788 | NCT03078803 (ClinicalTrials.gov) | March 28, 2017 | 12/1/2017 | Fecal Transplant for Crohn's Disease | A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease | Crohn Disease | Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo | University of Alberta | University of Calgary;McMaster University | Recruiting | 18 Years | N/A | All | 126 | Phase 2 | Canada |
| 789 | NCT03090139 (ClinicalTrials.gov) | March 28, 2017 | 22/3/2017 | Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets | Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE) | Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel Diseases | Drug: Anti-TNF Therapy | Takeda | NULL | Completed | 18 Years | N/A | All | 1731 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
| 790 | EUCTR2016-002918-43-IT (EUCTR) | 27/03/2017 | 17/06/2021 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn¿s Disease Patients Treated with Ustekinumab - . | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: STELARA Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 791 | EUCTR2016-002763-34-DE (EUCTR) | 27/03/2017 | 27/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 792 | EUCTR2016-002763-34-BG (EUCTR) | 23/03/2017 | 12/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 793 | EUCTR2016-002204-84-AT (EUCTR) | 22/03/2017 | 11/11/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: LY3074828 Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of;Belgium;Canada;Hungary;Czech Republic;France;Switzerland;United Kingdom;Russian Federation;Austria;Ukraine;United States | ||
| 794 | EUCTR2015-001924-40-CZ (EUCTR) | 21/03/2017 | 01/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 795 | EUCTR2016-002918-43-ES (EUCTR) | 20/03/2017 | 25/01/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | Janssen-Cilag International N.V. | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 796 | NCT03009396 (ClinicalTrials.gov) | March 18, 2017 | 26/12/2016 | Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease | An Open Label Study to Assess the Efficacy and Safety of Fixed-Dose Combination RHB-104 in Subjects With Active Crohn's Disease Despite 26 Weeks of Participation in the MAP US RHB-104-01 Study | Crohn Disease | Drug: RHB-104; a fixed-dose combination of 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine | RedHill Biopharma Limited | NULL | Completed | 18 Years | 76 Years | All | 54 | Phase 3 | United States;Canada;Czechia;Israel;New Zealand;Poland;Serbia |
| 797 | NCT02914600 (ClinicalTrials.gov) | March 17, 2017 | 22/9/2016 | Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease | Crohn's Disease | Drug: Filgotinib;Drug: Placebo | Gilead Sciences | Galapagos NV | Enrolling by invitation | 18 Years | N/A | All | 1000 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sri Lanka;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic;Mexico |
| 798 | EUCTR2015-001924-40-SK (EUCTR) | 16/03/2017 | 03/02/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Norway;Germany;Sweden | ||
| 799 | EUCTR2016-002918-43-SE (EUCTR) | 15/03/2017 | 19/01/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 800 | EUCTR2015-001179-36-BG (EUCTR) | 14/03/2017 | 17/01/2017 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | ||
| 801 | EUCTR2016-002763-34-PT (EUCTR) | 13/03/2017 | 05/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 802 | EUCTR2016-002939-15-NO (EUCTR) | 09/03/2017 | 20/03/2019 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Norway;Germany;Netherlands | ||
| 803 | EUCTR2016-000786-24-IT (EUCTR) | 07/03/2017 | 30/11/2016 | Efficacy and safety of thalidomide in pediatric patients with Crohn's disease | Thalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network - Talidomide in Crohn disease in Pediatrics | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: THALIDOMIDE CELGENE - 50 MG CAPSULA RIGIDA - USO ORALE - BLISTER (PVC/PE/ACLAR/ALU) 28 CAPSULE Product Name: INFLIXIMAB | IRCCS Burlo Garofolo | NULL | Not Recruiting | Female: yes Male: yes | 124 | Phase 3 | Italy | ||
| 804 | EUCTR2016-002918-43-GB (EUCTR) | 28/02/2017 | 10/01/2017 | Study to compare 2 treatment strategies in Crohn's Disease patients treated with Ustekinumab | Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Portugal;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 805 | NCT02852694 (ClinicalTrials.gov) | February 28, 2017 | 9/6/2016 | Reduce Risk for Crohn's Disease Patients | Risk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate vs Azathioprine or Adalimumab for Maintaining Remission in Patients at Low or High Risk for Aggressive Disease Course, respectively-a Treatment Strategy | Crohn's Disease | Drug: Methotrexate;Drug: Adalimumab;Drug: Azathioprine / 6 Mercaptopurine | PIBD-Net | European Commission | Recruiting | 6 Years | 17 Years | All | 312 | Phase 4 | France |
| 806 | EUCTR2016-000522-18-IT (EUCTR) | 24/02/2017 | 08/06/2021 | Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease. | Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL | Crohn Disease MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML Product Name: Methotrexate Product Code: N.A Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: N.A Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE Product Name: Azatioprina Product Code: N.A Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE Product Name: Purinethol | UMBERTO I - POLICLINICO DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 4 | France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 807 | EUCTR2016-003797-40-BE (EUCTR) | 23/02/2017 | 28/10/2016 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | ||
| 808 | EUCTR2015-001924-40-AT (EUCTR) | 21/02/2017 | 18/01/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | ||
| 809 | EUCTR2016-003797-40-DE (EUCTR) | 21/02/2017 | 09/11/2016 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 INN or Proposed INN: Not yet available Other descriptive name: APD334 | Arena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | ||
| 810 | EUCTR2016-003179-23-ES (EUCTR) | 21/02/2017 | 20/02/2017 | This trial will test the drug filgotinib for the treatment of small bowel Crohn’s disease. | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) | Small Bowel Crohn’s Disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Ukraine;Israel;Germany;Italy;United Kingdom | ||
| 811 | EUCTR2016-002763-34-SK (EUCTR) | 16/02/2017 | 12/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;Japan;New Zealand;Sweden | ||
| 812 | EUCTR2016-002939-15-SK (EUCTR) | 16/02/2017 | 12/01/2017 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | ||
| 813 | EUCTR2016-002763-34-HU (EUCTR) | 08/02/2017 | 08/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden;Austria;Czechia;Korea, Republic of;Netherlands;South Africa;Australia;Malaysia;France;India;Switzerland;Italy;Sri Lanka;Israel;Russian Federation;Ireland;Ukraine;Spain;Greece;Slovakia;Hong Kong;Taiwan;Portugal;Serbia;United States | ||
| 814 | EUCTR2016-002763-34-CZ (EUCTR) | 08/02/2017 | 16/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 815 | EUCTR2016-002939-15-AT (EUCTR) | 07/02/2017 | 05/01/2017 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Serbia;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Germany;Netherlands;Norway | ||
| 816 | EUCTR2016-002204-84-CZ (EUCTR) | 02/02/2017 | 13/10/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 817 | NCT03755583 (ClinicalTrials.gov) | February 1, 2017 | 18/11/2018 | Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease | Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease | Crohn Disease;Enteral Nutrition;Gastrointestinal Microbiome | Dietary Supplement: Exclusive Enteral Nutrition | Children's Hospital of Fudan University | NULL | Completed | 1 Year | 17 Years | All | 31 | N/A | China |
| 818 | JPRN-jRCTs031180415 | 01/02/2017 | 22/03/2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) | AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy. | Ishikawa Dai | NULL | Recruiting | >= 6age old | Not applicable | Both | 120 | N/A | Japan |
| 819 | EUCTR2016-002204-84-GB (EUCTR) | 01/02/2017 | 30/09/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 820 | EUCTR2016-002763-34-AT (EUCTR) | 31/01/2017 | 15/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden | ||
| 821 | EUCTR2016-002763-34-ES (EUCTR) | 31/01/2017 | 30/01/2017 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 822 | EUCTR2015-001179-36-CZ (EUCTR) | 30/01/2017 | 15/11/2016 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | ||
| 823 | EUCTR2016-001956-22-BE (EUCTR) | 25/01/2017 | 26/10/2016 | A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease | A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 1 | France;United States;Canada;Poland;Belgium;Germany | ||
| 824 | EUCTR2016-000612-14-GB (EUCTR) | 25/01/2017 | 29/09/2016 | BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | Serbia;United States;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 825 | EUCTR2015-001925-18-FI (EUCTR) | 25/01/2017 | 22/12/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 826 | EUCTR2016-002939-15-CZ (EUCTR) | 24/01/2017 | 01/11/2016 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease. | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - English A six week efficacy, safety and tolerability study of V565 in Crohn’s disease (HarbOR study) | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | ||
| 827 | NCT04272788 (ClinicalTrials.gov) | January 24, 2017 | 11/2/2020 | Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease | Association of Breg and Treg With the Clinical Effects of Infliximab in the Treatment of Patients With Crohn's Disease | Crohn Disease | Drug: Infliximab | Second Affiliated Hospital of Wenzhou Medical University | NULL | Completed | 18 Years | N/A | All | 32 | China | |
| 828 | EUCTR2016-002939-15-GB (EUCTR) | 19/01/2017 | 24/07/2020 | A clinical study testing the efficacy and safety of V565 in patients with Crohn's Disease | A Phase 2 study to investigate the efficacy, safety, and tolerability of six weeks treatment with V565 in subjects with active Crohn’s disease. - A six week efficacy, safety and tolerability study of V565 in Crohn's disease (the HarbOR study). | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: V565 Product Code: V565 INN or Proposed INN: not applied for Other descriptive name: V565 | VHsquared Ltd | NULL | Not Recruiting | Female: yes Male: yes | 126 | Phase 2 | United States;Slovakia;Ukraine;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Norway | ||
| 829 | NCT03000101 (ClinicalTrials.gov) | January 19, 2017 | 19/12/2016 | Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease | New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE) | Crohn's Disease;Ulcerative Colitis | Other: 100% pomegranate juice;Other: placebo beverage | IRCCS Azienda Ospedaliero-Universitaria di Bologna | University of Bologna;Conserve Italia;GAT Foods | Active, not recruiting | 18 Years | 80 Years | All | 18 | N/A | Italy |
| 830 | EUCTR2016-002204-84-HU (EUCTR) | 19/01/2017 | 09/11/2016 | A Crohn's Disease study | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo- Controlled Study of LY3074828 in Subjects with Active Crohn’s Disease (SERENITY) | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LY3074828 INN or Proposed INN: Not assigned Other descriptive name: LY3074828 | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Australia;Netherlands;Japan;Moldova, Republic of | ||
| 831 | EUCTR2016-003321-42-NL (EUCTR) | 18/01/2017 | 08/12/2016 | Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease. | Lengthening Adalimumab Dosing Interval in quiescent Crohn’s disease patients: the LADI study. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira (adalimumab) Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Radboud University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 832 | EUCTR2016-000612-14-DE (EUCTR) | 18/01/2017 | 05/09/2016 | BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 3 | Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina;Belarus;Serbia;United States;Greece;Ukraine;Turkey | ||
| 833 | NCT02968108 (ClinicalTrials.gov) | January 18, 2017 | 24/10/2016 | A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease | A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 45 | Phase 1 | United States;Belgium;Canada;France;Germany;Poland |
| 834 | NCT03261102 (ClinicalTrials.gov) | January 17, 2017 | 22/8/2017 | TDM Guided Early Optimization of ADAL in Crohn's Disease | Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study | Crohn Disease;Drug Monitoring;Inflammatory Bowel Diseases | Biological: Adalimumab | waqqas.afif | AbbVie | Recruiting | 18 Years | N/A | All | 200 | N/A | Canada |
| 835 | EUCTR2016-000634-21-PL (EUCTR) | 13/01/2017 | 11/10/2016 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 2 | United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 836 | EUCTR2015-001179-36-SK (EUCTR) | 13/01/2017 | 21/11/2016 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease. - RHB-104-01 | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | ||
| 837 | EUCTR2016-001956-22-PL (EUCTR) | 12/01/2017 | 01/12/2016 | A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease | A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 1 | France;United States;Canada;Belgium;Poland;Germany | ||
| 838 | EUCTR2016-000522-18-DE (EUCTR) | 05/01/2017 | 01/08/2016 | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy | Risk stratified randomized controlled trial in paediatric Crohn's Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively a treatment strategy - REDUCE-RISK in CD-PIBD-TRIAL | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Product Name: Methotrexat INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE | PIBD-Net | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 312 | Phase 3 | France;Hungary;Czech Republic;Canada;Poland;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 839 | EUCTR2016-002763-34-GB (EUCTR) | 04/01/2017 | 21/12/2016 | A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease | Moderately to Severely Active Crohn's Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 840 | NCT02862132 (ClinicalTrials.gov) | January 2017 | 31/7/2016 | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Vedolizumab | Shaare Zedek Medical Center | NULL | Recruiting | N/A | 18 Years | All | 120 | N/A | United States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom |
| 841 | NCT03056664 (ClinicalTrials.gov) | January 2017 | 24/8/2015 | The Role of MSC in the Treatment of Fistulas in Patients With Perianal Crohn's Disease | The Safety and Efficiacy of Local MSC Injection in the Treatment of Fistulas in Patients With Perianal Crohn's Disease | Crohn's Disease;Fistula | Procedure: Routine drainage surgery;Biological: MSC injection 01;Biological: MSC injection 02;Other: placebo | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Not yet recruiting | 18 Years | 65 Years | All | 3 | Phase 2/Phase 3 | NULL |
| 842 | NCT03012542 (ClinicalTrials.gov) | January 2017 | 4/1/2017 | Diet as Essential Therapy (DIET) for Inflammatory Bowel Disease | Randomized Trial of Diet for Crohn's Disease and Impact on Disease Activity and the Microbiome | Crohn Disease | Dietary Supplement: Diet 1;Dietary Supplement: Diet 2 | University of Washington | NULL | Unknown status | 18 Years | N/A | All | 32 | N/A | United States |
| 843 | EUCTR2016-000634-21-IT (EUCTR) | 29/12/2016 | 22/01/2021 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn¿s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn¿s Disease - - | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: - Product Code: JNJ-64304500 INN or Proposed INN: - Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA¿ Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: - | JANSSEN CILAG INTERNATIONAL NV | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 2 | United States;Korea, Democratic People's Republic of;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 844 | EUCTR2015-000555-24-FR (EUCTR) | 28/12/2016 | 03/01/2017 | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel. | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Academic Medical Center Amsterdam | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | France;Spain;Netherlands | ||
| 845 | EUCTR2015-003759-23-DE (EUCTR) | 16/12/2016 | 25/05/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT 494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand | ||
| 846 | EUCTR2016-000612-14-CZ (EUCTR) | 14/12/2016 | 24/10/2016 | BI 695501 versus Humira in patients with active Crohn’s disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity. | BI 695501 versus Humira® in patients with active Crohn’s disease: a randomized, double-blind, multicenter, parallel group, exploratory trial comparing efficacy, endoscopic improvement, safety, and immunogenicity | Moderately to severely active Crohn’s disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cyltezo Product Code: BI 695501 INN or Proposed INN: not available Trade Name: HUMIRA (adalimumab) Product Name: Humira INN or Proposed INN: ADALIMUMAB | Boehringer Ingelheim International GmbH | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Serbia;Greece;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Czech Republic;European Union;Croatia;Germany;Bosnia and Herzegovina | ||
| 847 | NCT02891226 (ClinicalTrials.gov) | December 14, 2016 | 1/9/2016 | A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease | A Phase 2, Multicenter, Randomized, Parallel-Arm, Placebo-Controlled Study of LY3074828 in Subjects With Active Crohn's Disease (SERENITY) | Crohn's Disease | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 75 Years | All | 191 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Hungary;Japan;Netherlands;Poland;Romania;Russian Federation;Switzerland;Ukraine;United Kingdom;Austria;Czech Republic;France |
| 848 | NCT02231814 (ClinicalTrials.gov) | December 2016 | 27/8/2014 | The Crohn's Disease Exclusion Diet With Partial Enteral Nutrition or Alone in Adult Patients With Crohn's Disease | Dietary Therapy Using the Crohn's Disease Exclusion Diet (CDED) With Partial Enteral Nutrition or Alone for Induction and Maintenance of Remission in in Adults With Mild to Moderate Crohn's Disease- A Pilot Study | Crohn's Disease | Dietary Supplement: Crohns Disease Exclusion Diet + PEN;Other: Crohns Disease Exclusion Diet | Prof. Arie Levine | NULL | Completed | 18 Years | 55 Years | All | 40 | N/A | Israel |
| 849 | NCT02976129 (ClinicalTrials.gov) | December 2016 | 23/11/2016 | A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease | Phase 2 Study to Investigate the Efficacy, Safety, and Tolerability of Six Weeks Treatment With V565 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: V565;Drug: Placebo | VHsquared Ltd. | NULL | Unknown status | 18 Years | 80 Years | All | 126 | Phase 2 | United States;Austria;Canada;Czechia;Germany;Hungary;Netherlands;Norway;Poland;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic |
| 850 | NCT02704624 (ClinicalTrials.gov) | December 2016 | 24/2/2016 | Effects of Supplementation of Vitamin D in Patients With Crohn's Disease | The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial | Crohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, Unspecified | Dietary Supplement: Vitamin D;Other: Placebo | Federal University of Juiz de Fora | Fundação de Amparo à Pesquisa do estado de Minas Gerais | Enrolling by invitation | 18 Years | 50 Years | All | 110 | Phase 4 | Brazil |
| 851 | EUCTR2014-003855-76-IT (EUCTR) | 29/11/2016 | 08/06/2021 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 - An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: Etrolizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 852 | EUCTR2014-003824-36-IT (EUCTR) | 29/11/2016 | 08/06/2021 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE - A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: Etrolizumab Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: etrolizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Czechia;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 853 | EUCTR2015-003759-23-GB (EUCTR) | 24/11/2016 | 24/05/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand | ||
| 854 | EUCTR2016-000634-21-HU (EUCTR) | 11/11/2016 | 12/09/2016 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 693 | Phase 2 | United States;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 855 | EUCTR2016-000634-21-GB (EUCTR) | 11/11/2016 | 03/08/2016 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 654 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 856 | EUCTR2016-000634-21-DE (EUCTR) | 08/11/2016 | 07/07/2016 | A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: JNJ-64304500 INN or Proposed INN: JNJ-64304500 Other descriptive name: JNJ-64304500-AAA Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 654 | Phase 2 | United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of | ||
| 857 | EUCTR2015-003759-23-DK (EUCTR) | 04/11/2016 | 24/05/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand | ||
| 858 | EUCTR2015-003759-23-NL (EUCTR) | 03/11/2016 | 06/06/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT 494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand | ||
| 859 | NCT02760615 (ClinicalTrials.gov) | November 1, 2016 | 2/5/2016 | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study | An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab | Takeda | NULL | Withdrawn | 18 Years | 55 Years | All | 0 | Phase 4 | United States |
| 860 | NCT02914561 (ClinicalTrials.gov) | October 31, 2016 | 22/9/2016 | Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease | Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Active, not recruiting | 18 Years | 75 Years | All | 1374 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sri Lanka;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic;Mexico |
| 861 | EUCTR2016-002061-54-IT (EUCTR) | 13/10/2016 | 15/11/2018 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | ||
| 862 | EUCTR2015-003759-23-BE (EUCTR) | 11/10/2016 | 14/07/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Hungary;Czech Republic;Canada;Puerto Rico;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | ||
| 863 | EUCTR2015-000852-12-NL (EUCTR) | 05/10/2016 | 30/05/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 864 | NCT02956538 (ClinicalTrials.gov) | October 2016 | 13/10/2016 | Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide | Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study | Crohn Disease | Drug: Thalidomide;Drug: placebo(for thalidomide) | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Recruiting | 18 Years | 50 Years | Both | 72 | Phase 0 | China |
| 865 | NCT02772965 (ClinicalTrials.gov) | October 2016 | 27/4/2016 | Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy | Pediatric Crohn's Disease | Drug: Methotrexate;Other: Sugar pill (placebo) | University of North Carolina, Chapel Hill | Patient-Centered Outcomes Research Institute;ImproveCareNow (ICN);The Leona M. and Harry B. Helmsley Charitable Trust;Children's Hospital Medical Center, Cincinnati;Grifols Diagnostics Solutions, Inc;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Active, not recruiting | N/A | 20 Years | All | 306 | Phase 3 | United States |
| 866 | NCT02883452 (ClinicalTrials.gov) | September 29, 2016 | 25/8/2016 | A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis | An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis | Crohn's Disease;Ulcerative Colitis (Part 2 Only) | Biological: CT-P13 | Celltrion | NULL | Completed | 18 Years | 75 Years | All | 181 | Phase 1 | Korea, Republic of |
| 867 | NCT02871635 (ClinicalTrials.gov) | September 28, 2016 | 15/8/2016 | BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity | BI 695501 Versus Humira® in Patients With Active Crohn's Disease: a Randomized, Double-blind, Multicenter, Parallel Group, Exploratory Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity | Crohn Disease | Drug: BI 695501;Drug: HUMIRA | Boehringer Ingelheim | NULL | Completed | 18 Years | 80 Years | All | 147 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Israel;Poland;Russian Federation;Serbia;Turkey;Ukraine;United Kingdom |
| 868 | EUCTR2015-001963-37-GR (EUCTR) | 28/09/2016 | 01/06/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 869 | EUCTR2015-003759-23-ES (EUCTR) | 19/09/2016 | 11/08/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT 494 in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Puerto Rico;Canada;Spain;Australia;Israel;New Zealand | ||
| 870 | EUCTR2015-003759-23-SK (EUCTR) | 05/09/2016 | 23/06/2016 | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Denmark;Norway;Germany;Netherlands;New Zealand | ||
| 871 | NCT02877134 (ClinicalTrials.gov) | August 25, 2016 | 19/8/2016 | A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease | A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: JNJ-64304500;Drug: Placebo;Drug: Ustekinumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 388 | Phase 2 | United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Czechia;Italy;Serbia |
| 872 | EUCTR2015-000555-24-ES (EUCTR) | 11/08/2016 | 15/07/2016 | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel. | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Academic Medical Center Amsterdam | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | Spain;Netherlands | ||
| 873 | NCT02630966 (ClinicalTrials.gov) | August 10, 2016 | 11/12/2015 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE) | Crohn's Disease | Drug: Vedolizumab;Drug: Placebo | Takeda | NULL | Completed | 18 Years | 80 Years | All | 34 | Phase 4 | United States;Canada;France;Italy;Netherlands;Spain;United Kingdom;Belgium |
| 874 | NCT02743806 (ClinicalTrials.gov) | August 1, 2016 | 15/4/2016 | Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab | Takeda | NULL | Active, not recruiting | 18 Years | 90 Years | All | 331 | Phase 4 | Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan |
| 875 | NCT02897661 (ClinicalTrials.gov) | August 2016 | 14/8/2016 | Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's Disease | Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease | Crohn's Diseases | Procedure: WMT;Dietary Supplement: EEN | The Second Hospital of Nanjing Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 30 | N/A | China |
| 876 | NCT02765256 (ClinicalTrials.gov) | August 2016 | 2/5/2016 | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease | Crohn's Disease | Drug: Fluconazole;Drug: Vancomycin;Drug: Neomycin;Drug: Ciprofloxacin;Drug: Polyethylene Glycol 3350;Drug: Promethazine;Drug: Fluconazole placebo | University of Pennsylvania | Children's Hospital of Philadelphia;Crohn's and Colitis Foundation | Completed | 18 Years | 75 Years | All | 8 | Phase 2 | United States |
| 877 | NCT02641392 (ClinicalTrials.gov) | July 25, 2016 | 23/12/2015 | A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease | Crohn's Disease | Drug: GED-0301;Other: Placebo | Celgene | NULL | Terminated | 12 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Estonia;Finland;Malaysia;New Zealand;South Africa |
| 878 | EUCTR2015-000852-12-ES (EUCTR) | 20/07/2016 | 20/07/2016 | NCT02630966 | TITLE A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn?s Disease SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE | Fistulizing Crohn?s Disease (CD) MedDRA version: 19.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;United States;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 879 | EUCTR2015-000481-58-NL (EUCTR) | 14/07/2016 | 15/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 880 | EUCTR2015-000852-12-FR (EUCTR) | 13/07/2016 | 15/03/2019 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;France;Canada;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 881 | EUCTR2016-000205-36-DE (EUCTR) | 11/07/2016 | 14/03/2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 | University Hospital Schleswig-Holstein (UKSH) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany | |||
| 882 | EUCTR2016-001638-84-NL (EUCTR) | 08/07/2016 | 17/05/2016 | Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study | Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study - ThiLDA-study | Crohn's disease & Colitis Ulcerosa;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Allopurinol Sandoz 100 mg, tabletten INN or Proposed INN: ALLOPURINOL INN or Proposed INN: ALLOPURINOL | Meander Medical Center | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 883 | EUCTR2015-000852-12-GB (EUCTR) | 07/07/2016 | 30/03/2016 | Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease | A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE | Fistulizing Crohn’s Disease (CD) MedDRA version: 20.0;Level: LLT;Classification code 10075465;Term: Fistulizing Crohn's disease;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio INN or Proposed INN: vedolizumab | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Canada;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 884 | NCT02768532 (ClinicalTrials.gov) | July 1, 2016 | 2/5/2016 | Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease | VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease | Crohn Disease | Drug: Vedolizumab | Centre Hospitalier Universitaire de Saint Etienne | Theradiag;Takeda | Recruiting | 18 Years | N/A | All | 93 | Phase 4 | France |
| 885 | NCT02793778 (ClinicalTrials.gov) | July 2016 | 1/6/2016 | Efficacy of CROWN in Repair and Maintenance of the Intestinal Mucosa in Patients With CD Receiving Anti-TNF Therapy | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy | Crohn's Disease | Drug: CROWN;Drug: CROWN Placebo | Prometheus Laboratories | Nestlé Health Science Spain;Nestec Ltd. | Terminated | 18 Years | 85 Years | All | 42 | Phase 2 | United States |
| 886 | EUCTR2015-000481-58-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 887 | EUCTR2015-000482-31-BE (EUCTR) | 30/06/2016 | 14/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Bosnia and Herzegovina;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;United States;Serbia | ||
| 888 | EUCTR2015-001963-37-BG (EUCTR) | 23/06/2016 | 13/04/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 889 | EUCTR2015-000555-24-NL (EUCTR) | 16/06/2016 | 10/02/2016 | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel. | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio) - REPREVIO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: vedolizumab Other descriptive name: VEDOLIZUMAB | Academic Medical Center Amsterdam | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 4 | Netherlands | ||
| 890 | EUCTR2015-000481-58-DE (EUCTR) | 14/06/2016 | 09/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 891 | EUCTR2015-000482-31-HR (EUCTR) | 13/06/2016 | 06/07/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 892 | EUCTR2016-001278-13-FI (EUCTR) | 08/06/2016 | 15/04/2016 | Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis | Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD | Ulcerative colitis and Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;Classification code 10058815;Term: Crohn's disease acute episode;Classification code 10057035;Term: Crohn's ileocolitis;Classification code 10011405;Term: Crohn's enteritis;Classification code 10011406;Term: Crohn's ileitis;Classification code 10076318;Term: Crohn's disease relapse;Level: PT;Classification code 10011401;Term: Crohn's disease;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10075466;Term: Fistulising Crohn's disease;Classification code 10066678;Term: Acute ulcerative colitis;Classification code 10075465;Term: Fistulizing Crohn's disease;Classification code 10011400;Term: Crohn's colitis;System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | Taina Sipponen | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Finland | ||
| 893 | EUCTR2015-001925-18-GR (EUCTR) | 01/06/2016 | 06/04/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | France;Australia;Denmark;Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 894 | EUCTR2015-000482-31-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 895 | EUCTR2015-000481-58-DK (EUCTR) | 31/05/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 896 | EUCTR2015-000481-58-ES (EUCTR) | 29/05/2016 | 20/04/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn?s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn?s Disease | Crohn s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 897 | EUCTR2015-000482-31-ES (EUCTR) | 29/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn?s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn?s Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 898 | EUCTR2015-000482-31-NL (EUCTR) | 25/05/2016 | 27/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative Colitis Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC Trade Name: Entyvio INN or Proposed INN: - Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 899 | NCT02782663 (ClinicalTrials.gov) | May 18, 2016 | 23/5/2016 | A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease | A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease | Crohn's Disease (CD) | Drug: ABT-494 | AbbVie | NULL | Active, not recruiting | 18 Years | 75 Years | All | 210 | Phase 2 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Romania;Slovakia;Spain;United Kingdom |
| 900 | EUCTR2015-002025-19-IT (EUCTR) | 17/05/2016 | 05/11/2020 | An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 22.1;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: RPC1063 Product Code: [RPC1063] INN or Proposed INN: Ozanimod Product Name: RPC0163 Product Code: [RPC0163] INN or Proposed INN: Ozanimod | CELGENE INTERNATIONAL II SàRL | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Italy | ||
| 901 | EUCTR2015-000609-38-DE (EUCTR) | 10/05/2016 | 28/01/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 902 | EUCTR2015-001925-18-HR (EUCTR) | 09/05/2016 | 06/07/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 903 | EUCTR2015-000482-31-DE (EUCTR) | 09/05/2016 | 09/03/2016 | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;Sweden;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Lithuania;Turkey;Czechia;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Denmark;Australia;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;Serbia;United States | ||
| 904 | EUCTR2015-000482-31-HU (EUCTR) | 09/05/2016 | 22/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 905 | EUCTR2015-001963-37-HR (EUCTR) | 05/05/2016 | 21/06/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;United States;Taiwan;Estonia;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Hungary;United Kingdom;Austria;Turkey;Finland;Bosnia and Herzegovina;Korea, Republic of;Latvia;Netherlands;South Africa;Denmark;Australia;Malaysia;France;Switzerland;Italy;Colombia;Chile;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia | ||
| 906 | EUCTR2015-000482-31-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 907 | EUCTR2015-000481-58-LT (EUCTR) | 04/05/2016 | 18/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 908 | EUCTR2015-001963-37-BE (EUCTR) | 03/05/2016 | 10/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 909 | ChiCTR-OPC-16008655 | 2016-05-01 | 2016-06-16 | Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China | Efficacy and safety of thalidomide for patients with Crohn's Disease: a prospective multicenter observational study from China | Crohn‘s Disease | 1:Thalidomide 75-100mg qd;2:Thalidomide 150-200mg qd;3:Thalidomide 75-100mg qd+MTX 20-25mg /W; | Peking Union Medical College Hospital | NULL | Recruiting | 16 | 70 | Both | 1:90;2:90;3:90; | China | |
| 910 | NCT02538341 (ClinicalTrials.gov) | May 2016 | 18/8/2015 | Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) | Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial) | Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Active, not recruiting | 50 Years | N/A | All | 617 | Phase 2 | United States |
| 911 | EUCTR2015-000609-38-BE (EUCTR) | 21/04/2016 | 25/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 912 | EUCTR2015-001925-18-BG (EUCTR) | 20/04/2016 | 18/03/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 913 | EUCTR2015-000481-58-IT (EUCTR) | 18/04/2016 | 11/02/2021 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as MaintenanceTherapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 824 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 914 | EUCTR2015-000482-31-IT (EUCTR) | 18/04/2016 | 22/01/2021 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn¿s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn¿s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 915 | JPRN-JapicCTI-163220 | 15/4/2016 | 08/04/2016 | A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn's Disease | Ulcerative colitis or Crohn's disease | Intervention name : Vedolizumab SC 108 mg INN of the intervention : Vedolizumab Dosage And administration of the intervention : Group A: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who completed the Maintenance Period (Week 52), or were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6 will receive vedolizumab SC 108 mg Q2W; Group B: Participants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure, or Participants from current study who experience treatment failure while on study will receive vedolizumab SC 108 mg QW. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 746 | Phase 3 | Japan, Refer to Othersection |
| 916 | NCT02620046 (ClinicalTrials.gov) | April 15, 2016 | 19/11/2015 | A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab SC | Takeda | NULL | Active, not recruiting | 18 Years | 80 Years | All | 746 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic |
| 917 | EUCTR2015-001963-37-DK (EUCTR) | 15/04/2016 | 22/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Sweden;Norway;Germany;New Zealand;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria | ||
| 918 | EUCTR2015-001963-37-SK (EUCTR) | 14/04/2016 | 07/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 919 | EUCTR2015-001925-18-SK (EUCTR) | 14/04/2016 | 30/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;United Kingdom;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 920 | EUCTR2015-000481-58-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 921 | EUCTR2015-000482-31-CZ (EUCTR) | 13/04/2016 | 21/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 922 | EUCTR2015-001249-10-IS (EUCTR) | 12/04/2016 | 02/03/2016 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Germany;Iceland;United Kingdom;New Zealand | ||
| 923 | NCT02749630 (ClinicalTrials.gov) | April 11, 2016 | 12/4/2016 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 70 | Phase 1 | Germany;United Kingdom;Canada |
| 924 | EUCTR2015-001963-37-ES (EUCTR) | 08/04/2016 | 03/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn?s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn?s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 925 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 926 | EUCTR2015-000481-58-SE (EUCTR) | 05/04/2016 | 17/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 927 | EUCTR2015-000482-31-SE (EUCTR) | 05/04/2016 | 16/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 928 | EUCTR2015-000609-38-HU (EUCTR) | 04/04/2016 | 24/02/2016 | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovenia;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 929 | NCT02685683 (ClinicalTrials.gov) | April 4, 2016 | 15/2/2016 | Pharmacodynamic and Clinical Outcome Study of Mongersen in Patients With Crohn's Disease | A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: GED-0301 | Celgene | NULL | Terminated | 18 Years | N/A | All | 18 | Phase 2 | Italy |
| 930 | EUCTR2015-001925-18-CZ (EUCTR) | 01/04/2016 | 22/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 931 | EUCTR2015-001963-37-CZ (EUCTR) | 01/04/2016 | 22/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn's disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 932 | NCT02324699 (ClinicalTrials.gov) | April 2016 | 19/12/2014 | Corticosteroids With Vedolizumab in Crohn's Disease | Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial | Crohn's Disease | Drug: Prednisone;Drug: Placebo;Drug: Vedolizumab | Icahn School of Medicine at Mount Sinai | Takeda | Terminated | 18 Years | 70 Years | All | 1 | Phase 4 | United States |
| 933 | EUCTR2015-000481-58-BG (EUCTR) | 31/03/2016 | 16/02/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Phase 3 | United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 934 | EUCTR2015-000609-38-BG (EUCTR) | 30/03/2016 | 15/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | Allergan Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 935 | EUCTR2015-001963-37-PT (EUCTR) | 28/03/2016 | 10/02/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 936 | EUCTR2015-001925-18-PT (EUCTR) | 28/03/2016 | 10/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 937 | EUCTR2015-001925-18-BE (EUCTR) | 25/03/2016 | 20/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden;Serbia;Portugal;United States;Estonia | ||
| 938 | EUCTR2015-000609-38-NL (EUCTR) | 24/03/2016 | 02/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - MEDI2070-LUX | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of | ||
| 939 | EUCTR2015-000482-31-BG (EUCTR) | 23/03/2016 | 16/02/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden | ||
| 940 | EUCTR2015-001963-37-IT (EUCTR) | 23/03/2016 | 23/02/2018 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: Mongersen | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 941 | EUCTR2015-000482-31-GB (EUCTR) | 21/03/2016 | 08/03/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 942 | EUCTR2015-001963-37-GB (EUCTR) | 15/03/2016 | 29/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;United States;Serbia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Pakistan;Finland;Oman;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 943 | EUCTR2015-000481-58-GB (EUCTR) | 14/03/2016 | 08/03/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’ | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Entyvio Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;Denmark;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 944 | EUCTR2015-001925-18-ES (EUCTR) | 07/03/2016 | 04/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn?s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn?s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 945 | EUCTR2012-002702-51-NO (EUCTR) | 07/03/2016 | 03/02/2016 | Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study | Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT | Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima Trade Name: Inflectra Product Name: Inflectra Product Code: EMEA/H/C/002778 | Department of medical gastroenterology, Herlev Hospital | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 946 | EUCTR2015-000609-38-IT (EUCTR) | 04/03/2016 | 21/02/2018 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to SevereCrohn's Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy - nd | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 Other descriptive name: anticorpo monoclonale anti-IL-23 | MEDIMMUNE, LLC | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 947 | EUCTR2015-001925-18-DK (EUCTR) | 04/03/2016 | 06/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 948 | NCT02538354 (ClinicalTrials.gov) | March 2016 | 20/8/2015 | The Effect of Riboflavin in Crohn's Disease | The Effect of Riboflavin Supplementation on Faecalibacterium Prausnitzii in Crohn's Disease | Crohn Disease | Dietary Supplement: Riboflavin supplementation | University Medical Center Groningen | NULL | Completed | 18 Years | 65 Years | All | 70 | N/A | Netherlands |
| 949 | NCT02769494 (ClinicalTrials.gov) | March 2016 | 9/3/2016 | The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer | The Efficacy of Topically Applied Mesalazine Sustained-Release Tablets in Oral Lesions of Crohn's Disease | Crohn's Disease;Oral Ulcer | Drug: Mesalazine Sustained-Release Tablets;Drug: Riboflavin Sodium Phosphate Injection | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 65 Years | Both | 40 | Phase 3 | China |
| 950 | EUCTR2015-000609-38-ES (EUCTR) | 29/02/2016 | 08/02/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn?s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune, Ltd, a wholly owned subsidiary of AstraZeneca UK | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 951 | EUCTR2015-001963-37-DE (EUCTR) | 26/02/2016 | 11/01/2016 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 952 | EUCTR2015-001925-18-GB (EUCTR) | 24/02/2016 | 18/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety o | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | ||
| 953 | EUCTR2015-001963-37-LV (EUCTR) | 18/02/2016 | 01/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 954 | EUCTR2015-001925-18-LV (EUCTR) | 18/02/2016 | 01/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 955 | EUCTR2015-000609-38-CZ (EUCTR) | 15/02/2016 | 29/01/2016 | A Phase 2B study of multiple doses to evaluate the safety and treatment benefits of MEDI2070 in subjects with Crohn's Disease who have failed or are Intolerant to Anti Tumor Necrosis Factor-Alpha Therapy | A Phase 2B Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-Tumor Necrosis Factor-Alpha-Therapy | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 INN or Proposed INN: Not assigned Other descriptive name: Anti-IL-23 monoclonal antibody | MedImmune Limited | NULL | Not Recruiting | Female: yes Male: yes | 342 | Phase 2 | United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of | ||
| 956 | EUCTR2015-001925-18-HU (EUCTR) | 15/02/2016 | 17/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 957 | EUCTR2015-001963-37-HU (EUCTR) | 15/02/2016 | 17/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 958 | EUCTR2015-001963-37-SE (EUCTR) | 10/02/2016 | 17/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 959 | EUCTR2015-001925-18-DE (EUCTR) | 09/02/2016 | 07/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 960 | NCT02186275 (ClinicalTrials.gov) | February 2016 | 4/7/2014 | The Vitamin D in Pediatric Crohn's Disease | Randomized Controlled Trial of High Dose Vitamin D in Children With Newly Diagnosed Crohn's Disease for the Prevention of Relapses | Crohn's Disease | Drug: Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day;Drug: Vitamin D3 800 UI/day then 800 UI/day | St. Justine's Hospital | Canadian Institutes of Health Research (CIHR) | Completed | 9 Years | 18 Years | All | 25 | Phase 3 | Canada |
| 961 | EUCTR2015-001925-18-AT (EUCTR) | 29/01/2016 | 22/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 962 | EUCTR2015-001963-37-AT (EUCTR) | 29/01/2016 | 22/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 963 | EUCTR2015-001693-18-IT (EUCTR) | 29/01/2016 | 07/03/2018 | - | A Phase 2, Open-Label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects with Active Crohn's Disease - GED-0301-CD-005 | Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | INN or Proposed INN: Mongersen Other descriptive name: GED-0301 | CELGENE CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 964 | EUCTR2015-002025-19-PL (EUCTR) | 28/01/2016 | 21/12/2015 | An open-label study to assess improvement in patients with Moderate to Severe Crohn’s Disease taking RPC1063 orally | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 | Celgene International II Sàrl (CIS II), a wholly owned subsidiary of Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine | ||
| 965 | EUCTR2015-001925-18-SE (EUCTR) | 27/01/2016 | 25/11/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 966 | EUCTR2015-000482-31-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Long-term effectiveness and Safety of Vedolizumab SC as a Therapy for Ulcerative Colitis and Crohn's Disease | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects with Ulcerative Colitis and Crohn’s Disease - Vedolizumab SC Long-Term Open-Label Extension Study | Ulcerative ColitisCrohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 692 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Denmark;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 967 | EUCTR2015-000481-58-SK (EUCTR) | 22/01/2016 | 05/01/2016 | Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease | Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Product Name: Vedolizumab SC Product Code: MLN0002 SC INN or Proposed INN: Vedolizumab SC | Takeda Development Centre Europe, Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 824 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Japan;Sweden;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Turkey;Lithuania;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Denmark;Australia;Italy;Israel;Russian Federation;Ukraine;Spain;Slovakia;Estonia;Taiwan;United States;Serbia | ||
| 968 | NCT02742597 (ClinicalTrials.gov) | January 12, 2016 | 21/3/2016 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;Unity Health Toronto;University Health Network, Toronto;Michael Garron Hospital;Providence Healthcare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Active, not recruiting | 18 Years | 80 Years | All | 175 | N/A | Canada |
| 969 | NCT02574637 (ClinicalTrials.gov) | January 5, 2016 | 24/9/2015 | Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease | A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease | Drug: Brazikumab IV Infusion;Drug: Brazikumab SC Injection;Drug: Placebo | Allergan | NULL | Terminated | 18 Years | 80 Years | All | 29 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Russian Federation;Spain;Bulgaria;Czech Republic;Korea, Republic of;Poland;Turkey;United Kingdom |
| 970 | EUCTR2014-003509-13-IT (EUCTR) | 05/01/2016 | 19/01/2021 | Vedolizumab IV in subjects with Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects WithModerately to Severely Active Crohn's Disease Treated With VedolizumabIV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Vedolizumab IV (Entyvio¿) | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Hungary;Canada;Belgium;Poland;Italy | ||
| 971 | NCT02611817 (ClinicalTrials.gov) | January 4, 2016 | 19/11/2015 | Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD) | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Drug: Vedolizumab SC 108 mg;Drug: Placebo;Drug: Vedolizumab IV 300 mg | Takeda | NULL | Completed | 18 Years | 80 Years | All | 644 | Phase 3 | United States;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic;Spain |
| 972 | JPRN-JapicCTI-163386 | 04/1/2016 | 28/09/2016 | Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Crohn's Disease | Intervention name : Vedolizumab SC 108 mg INN of the intervention : Vedolizumab Dosage And administration of the intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: vedolizumab SC 108 mg injection once every 2 weeks (Q2W) starting at Week 6 up to Week 50 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Open-label Induction: vedolizumab IV 300 mg, infusion at Week 0 (Day 1) and Week 2 (Day 15), Double-blind Maintenance: matching placebo to vedolizumab SC injection Q2W starting at Week 6 up to Week 50 | Takeda Pharmaceutical Company Limited | NULL | complete | 18 | 80 | BOTH | 644 | Phase 3 | Japan, Refer to Othersection |
| 973 | ChiCTR1800020305 | 2016-01-01 | 2018-12-23 | A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease | Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI | crohn's disease;K50.900 | Group 2:infliximab + azathioprine;Group 1:infliximab alone; | Department of Gastroenterology, Nanfang Hospital, Southern Medical University | NULL | Recruiting | 12 | 80 | Both | Group 2:41;Group 1:45; | China | |
| 974 | ChiCTR-IIR-16007751 | 2016-01-01 | 2016-01-13 | Clinical study of acupuncture and moxibustion treatment for Cohn's disease | Molecular regulation mechanism of acupuncture and moxibustion therapy in inhibiting epithelial-mesenchymal transition of intestinal fibrosis in Crohn's disease | Crohn's disease | Acupuncture Group:Acupuncture, Moxibustion, Prednisone and azathioprine;Placebo acupuncture group:Placebo acupuncture, moxibustion, Prednisone and azathioprine;Drug Group:Prednisone and azathioprine; | Shanghai Research Institute of Acupuncture and Meridian | NULL | Recruiting | 16 | 70 | Both | Acupuncture Group:40;Placebo acupuncture group:40;Drug Group:40; | I (Phase 1 study) | China |
| 975 | NCT02680756 (ClinicalTrials.gov) | January 2016 | 9/2/2016 | Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD | A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease | Anemia, Iron-Deficiency;Inflammatory Bowel Disease;Crohn's Disease | Drug: Ferric Maltol;Drug: Ferric Carboxy Maltose | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 250 | Phase 3 | United States;Belgium;France;Germany;Hungary;Spain |
| 976 | NCT02532738 (ClinicalTrials.gov) | January 2016 | 23/8/2015 | The Efficiency of MSC in Refractory Crohn's Disease | A Stage II Clinical Trial Comparing the Efficiacy of Routine Treatment Combined With or Without MSC Therapy in Refractory Crohn's Disease | Crohn's Disease | Drug: Routine Treatment of CD;Biological: MSC treatment 01;Biological: MSC treatment 02;Other: NS | Sixth Affiliated Hospital, Sun Yat-sen University | Third Affiliated Hospital, Sun Yat-Sen University;Nanfang Hospital of Southern Medical University | Not yet recruiting | 18 Years | 65 Years | Both | 3 | Phase 2/Phase 3 | NULL |
| 977 | NCT02465944 (ClinicalTrials.gov) | January 2016 | 18/5/2015 | A Pilot Study of FFP104 in Subjects With Crohn's Disease | A Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of FFP104 in the Treatment of Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: FFP104;Drug: Placebo | Fast Forward Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | Both | 24 | Phase 1/Phase 2 | Belgium;Netherlands |
| 978 | EUCTR2015-002025-19-HU (EUCTR) | 30/12/2015 | 29/10/2015 | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy - Open-Label Endoscopic Improvement Trial of RPC1063 for Moderate to Severe Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011402;Term: Crohn's disease (colon);Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0,25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 | Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Italy | ||
| 979 | EUCTR2015-001963-37-EE (EUCTR) | 29/12/2015 | 07/12/2015 | A long-term extension study to evaluate the drug mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, long-term active treatment extension study of mongersen (GED-0301) in subjects with Crohn’s disease - A long-term study to explore the safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 19.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1414 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 980 | EUCTR2015-001925-18-EE (EUCTR) | 29/12/2015 | 07/12/2015 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | ||
| 981 | EUCTR2015-001249-10-GB (EUCTR) | 11/12/2015 | 06/10/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;Italy;New Zealand;United Kingdom | ||
| 982 | NCT02596893 (ClinicalTrials.gov) | December 8, 2015 | 3/11/2015 | Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Terminated | 18 Years | N/A | All | 701 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Bosnia and Herzegovina;Czech Republic;Former Serbia and Montenegro;South Africa |
| 983 | NCT02678052 (ClinicalTrials.gov) | December 1, 2015 | 4/2/2016 | OTIS Vedolizumab Pregnancy Exposure Registry | Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry | Colitis, Ulcerative;Crohn's Disease | Drug: Vedolizumab;Biological: Other Biological Agent | Takeda | NULL | Active, not recruiting | 18 Years | 44 Years | Female | 300 | United States;Canada | |
| 984 | NCT02636517 (ClinicalTrials.gov) | December 2015 | 16/12/2015 | Fecal Microbiome Transplant | Fecal Microbiome Transplant in Pediatric C. Difficile | Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Children's Hospital of Philadelphia | NULL | Active, not recruiting | 3 Years | 21 Years | All | 250 | N/A | United States |
| 985 | EUCTR2014-003240-12-NL (EUCTR) | 27/11/2015 | 21/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 986 | EUCTR2015-001249-10-IT (EUCTR) | 11/11/2015 | 21/02/2018 | An investigational study to assess the safety and effectiveness of a newinvestgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, MulticenterStudy Evaluating the Safety and Efficacy of GS-5745 in Subjects withModerately to Severely Active Crohn's Disease - GS-US-395-1663 | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GS-5745 Product Code: nessuno | GILEAD SCIENCES INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;Italy | ||
| 987 | EUCTR2015-001249-10-DE (EUCTR) | 02/11/2015 | 14/08/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand | ||
| 988 | NCT02597829 (ClinicalTrials.gov) | November 2015 | 27/10/2015 | Does Clinical Response Correlate With Serum Certolizumab Levels? | Does Clinical Response Correlate With Serum Certolizumab Levels? A Prospective Open Label Trial of Adult Patients With Active Crohn's Disease (APOLLO) | Crohn's Disease | Drug: Certolizumab Pegol | Shafran Gastroenterology Center | UCB Pharma;UCB Pharma | Not yet recruiting | 18 Years | 70 Years | Both | 20 | Phase 4 | United States |
| 989 | NCT02622763 (ClinicalTrials.gov) | November 2015 | 1/12/2015 | Intralesional Tolerogenic Dendritic Cells in Crohn's Disease Treatment | Safety and Clinical Efficacy Evaluation of Intralesional Administration of Tolerogenic Dendritic Cells in Patients With Refractory Crohn's Disease | Crohn's Disease | Biological: Tolerogenic Dendritic Cells | Fundacion Clinic per a la Recerca Biomédica | NULL | Terminated | 18 Years | 65 Years | All | 3 | Phase 1 | Spain |
| 990 | NCT02926300 (ClinicalTrials.gov) | November 2015 | 11/11/2015 | Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/2 | Korea, Republic of |
| 991 | EUCTR2015-001834-15-NL (EUCTR) | 30/10/2015 | 11/08/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of | ||
| 992 | EUCTR2014-003240-12-NO (EUCTR) | 19/10/2015 | 08/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 993 | EUCTR2014-005666-29-GB (EUCTR) | 16/10/2015 | 11/09/2015 | A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease | A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease. - A study of Thetanix in young people with stable Crohn's disease | Crohn's disease in young persons MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Thetanix Product Code: B. theta INN or Proposed INN: Colony-purified Bacteroides thetaiotaomicron (B.theta) Other descriptive name: B. theta | 4D Pharma | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 994 | EUCTR2014-004108-31-CZ (EUCTR) | 13/10/2015 | 02/06/2015 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU | Moderately Active Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United Kingdom;Hungary;Czech Republic;Ukraine;Ireland;Russian Federation | ||
| 995 | EUCTR2012-002702-51-FI (EUCTR) | 12/10/2015 | 30/09/2015 | Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study | Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT | Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | Department of medical gastroenterology, Herlev Hospital | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 996 | NCT02531113 (ClinicalTrials.gov) | October 9, 2015 | 20/8/2015 | Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease | A Phase 2, Multi-Center, Open-Label Induction Trial With Extension Period to Access Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients With Moderately to Severely Active Crohn's Disease Receiving Oral RPC1063 as Induction Therapy | Crohn's Disease | Drug: RPC1063 | Celgene | NULL | Completed | 18 Years | 75 Years | All | 69 | Phase 2 | United States;Canada;Hungary;Poland;Ukraine;Italy |
| 997 | NCT02177071 (ClinicalTrials.gov) | October 9, 2015 | 26/6/2014 | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy | A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy | Crohn's Disease | Drug: INFLIXIMAB;Drug: AZATHIOPRINE;Drug: MERCAPTOPURINE;Drug: Methotrexate | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Saint-Louis Hospital, Paris, France | Active, not recruiting | 18 Years | 65 Years | All | 211 | Phase 4 | Australia;Belgium;France |
| 998 | EUCTR2014-003509-13-BE (EUCTR) | 06/10/2015 | 10/07/2015 | Effect of Vedolizumab IV in subjects with Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Vedolizumab IV (Entyvio™) Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Hungary;Canada;Poland;Belgium | ||
| 999 | EUCTR2015-001249-10-CZ (EUCTR) | 01/10/2015 | 14/08/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand | ||
| 1000 | NCT02847884 (ClinicalTrials.gov) | October 2015 | 30/11/2015 | IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study | IDeaL Pilot Study - Infliximab Dose to Level: Pilot Study | Inflammatory Bowel Disease;Crohn's Disease | Biological: Infliximab | University of Alberta | The Hospital for Sick Children;The Children's Hospital of Winnipeg;Alberta Children's Hospital;Provincial Health Services Authority;Children's Hospital of Eastern Ontario | Completed | 2 Years | 17 Years | All | 28 | Canada | |
| 1001 | EUCTR2013-003199-11-BE (EUCTR) | 25/09/2015 | 27/07/2015 | CURE | Changing the coUrse of cRohn's disease with an Early use of adalimumab: The CURE study. - CURE | Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Adalimumab Product Name: Humira | GETAID - Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | France;Belgium | ||
| 1002 | EUCTR2015-001834-15-ES (EUCTR) | 24/09/2015 | 18/06/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Belgium;Spain;Germany;Netherlands;Korea, Republic of | ||
| 1003 | EUCTR2015-001834-15-DE (EUCTR) | 24/09/2015 | 14/08/2015 | A long term extension trial of BI 655066/ABBV-066 (risankizumab) in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066/ABBV-066 (risankizumab), in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: Risankizumab Product Code: BI 655066 90 mg/ml INN or Proposed INN: Risankizumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 1004 | EUCTR2015-001249-10-HU (EUCTR) | 22/09/2015 | 10/08/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn’s Disease | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand | ||
| 1005 | EUCTR2015-001249-10-ES (EUCTR) | 16/09/2015 | 11/09/2015 | An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderate and severe Crohn's disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Crohn?s Disease | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 175 | Phase 2 | United States;Czech Republic;Hungary;Canada;Spain;Australia;South Africa;Iceland;Germany;United Kingdom;New Zealand | ||
| 1006 | NCT02513459 (ClinicalTrials.gov) | September 16, 2015 | 30/7/2015 | A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease | An Open Label, Single Group, Long Term Safety Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Risankizumab 600 mg IV;Drug: Risankizumab 180 mg SC | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 65 | Phase 2 | United States;Belgium;Canada;Germany;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom |
| 1007 | EUCTR2015-001954-14-NL (EUCTR) | 14/09/2015 | 25/08/2015 | Efficacy and safety of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission: the SIMILAR Trial” | SIMILAR Trial: Santeon InflixMab biosimILAr ResearchA randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission. - SIMILAR Trial: Santeon InflixMab biosimILAr Research | ulcerative colitis and Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra 100 mg powder for concentrate for solution for infusion Product Name: Inflectra 100 mg powder for concentrate for solution for infusion Trade Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Name: Remicade 100 mg powder for concentrate for solution for infusion. Product Code: EMEA/H/C/000240 | Santeon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1008 | EUCTR2014-003824-36-DE (EUCTR) | 10/09/2015 | 25/03/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden;Serbia;United States;Estonia;Slovakia | ||
| 1009 | EUCTR2014-003855-76-DE (EUCTR) | 09/09/2015 | 25/03/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1010 | EUCTR2014-003824-36-NL (EUCTR) | 03/09/2015 | 02/04/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1011 | EUCTR2014-003855-76-NL (EUCTR) | 03/09/2015 | 16/04/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1012 | EUCTR2015-001834-15-BE (EUCTR) | 01/09/2015 | 01/07/2015 | A long term extension trial of BI 655066 in patients with moderately to severely active Crohn's disease | An open label, single group, long term safety extension trial of BI 655066, in patients with moderately to severely active Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 62 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Belgium;Germany;Netherlands;Korea, Republic of | ||
| 1013 | NCT03010787 (ClinicalTrials.gov) | September 2015 | 12/12/2016 | A First Time in Human Study in Healthy Volunteers and Patients | A Four Part, Phase 1, First Time in Human, Single Centre Study in Healthy Male Subjects, Patient Volunteers With Crohn's Disease and in Healthy Patient Volunteers With a Terminal Ileostomy | Crohn's Disease | Drug: V565;Drug: Placebo | VHsquared Ltd. | NULL | Completed | 18 Years | 65 Years | All | 47 | Phase 1 | United Kingdom |
| 1014 | NCT02417974 (ClinicalTrials.gov) | September 2015 | 1/4/2015 | Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) | Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) | Crohn's Disease | Biological: Fecal Microbiota Transplant (FMT) | Boston Medical Center | Brigham and Women's Hospital;Beth Israel Deaconess Medical Center;Massachusetts Institute of Technology | Terminated | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 1015 | NCT02522169 (ClinicalTrials.gov) | September 2015 | 3/5/2015 | TOPIT; Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease | Verbessertes Therapiemanagement für pädiatrische CED-Patienten Mit Chronisch-entzündlicher Darmerkrankung: Eine Randomisierte Multizentrische Studie, Welche Die Effektivität Einer Talspiegel-gesteuerten Infliximab-Erhaltungsphase Mit Dem herkömmlichen Dosierungsregime Vergleicht Trough Level Optimized Pediatric Inflammatory Bowel Disease Therapy: A Randomized Multicenter Study Comparing Effectiveness of Trough Level Optimized Infliximab Maintenance Therapy With Standard Dosing Regimen of Pediatric Patients With Crohn's Disease | Pediatric Crohns Disease | Drug: Infliximab | Klinikum Westbrandenburg GmbH | NULL | Not yet recruiting | 6 Years | 17 Years | Both | 120 | N/A | NULL |
| 1016 | EUCTR2014-004108-31-HU (EUCTR) | 27/08/2015 | 28/04/2015 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately Active Crohn’s Disease - MAP EU | Moderately Active Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Slovakia;Belgium;Spain;Ukraine;Ireland;Russian Federation;Netherlands;Germany;United Kingdom | ||
| 1017 | EUCTR2014-003240-12-PL (EUCTR) | 21/08/2015 | 09/06/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators orAnti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1018 | EUCTR2014-003509-13-PL (EUCTR) | 18/08/2015 | 12/06/2015 | Effect of Vedolizumab IV in subjects with Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Vedolizumab IV (Entyvio™) Product Name: Vedolizumab IV Product Code: MLN0002 Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Hungary;Canada;Belgium;Poland | ||
| 1019 | NCT02499783 (ClinicalTrials.gov) | August 17, 2015 | 14/7/2015 | Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein | Crohn's Disease | Biological: adalimumab;Other: placebo | AbbVie | NULL | Completed | 18 Years | 70 Years | All | 205 | Phase 3 | China |
| 1020 | EUCTR2014-003824-36-SE (EUCTR) | 12/08/2015 | 27/01/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1021 | EUCTR2014-003855-76-SE (EUCTR) | 12/08/2015 | 27/01/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1022 | EUCTR2012-002702-51-SE (EUCTR) | 10/08/2015 | 10/06/2015 | Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study | Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT | Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima | Department of medical gastroenterology S, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 1023 | EUCTR2014-004887-39-PL (EUCTR) | 08/08/2015 | 07/07/2015 | A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis | Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC). MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: SB5 INN or Proposed INN: ADALIMUMAB Product Code: SB5 INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd | NULL | Not Recruiting | Female: yes Male: yes | Poland | ||||
| 1024 | NCT02538679 (ClinicalTrials.gov) | August 7, 2015 | 20/8/2015 | A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Techniques | A Comparison of Ultrasound Guided Transversus Abdominis Plane Nerve Block Technique Versus Laparoscopic Transversus Abdominis Plane Nerve Block Technique Versus No Block on Postoperative Opioid Consumption After Major Colorectal Surgery | Crohn's Disease;Inflammatory Bowel Disease;Postoperative Pain | Other: Placebo;Drug: US TAP Bupivacaine/Epinephrine;Drug: Lap TAP Bupivacaine/Epinephrine | Cedars-Sinai Medical Center | NULL | Completed | 18 Years | 90 Years | All | 127 | N/A | NULL |
| 1025 | EUCTR2014-003824-36-RO (EUCTR) | 05/08/2015 | 05/10/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Romania;Germany;New Zealand;Sweden | ||
| 1026 | NCT02452151 (ClinicalTrials.gov) | August 2015 | 20/5/2015 | Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial | Santeon InflixMab biosimILAr Research A Randomized, Controlled, Double Blind, Phase 4 Noninferiority Trial to Assess Efficacy of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission. | Colitis, Ulcerative;Crohn's Disease | Drug: Infliximab-Biosimilar;Drug: Infliximab-Innovator | Onze Lieve Vrouwe Gasthuis | Santeon | Not yet recruiting | 18 Years | N/A | Both | 300 | Phase 4 | NULL |
| 1027 | NCT02193750 (ClinicalTrials.gov) | August 2015 | 16/7/2014 | Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease | Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial | Crohn's Disease | Dietary Supplement: Placebo;Dietary Supplement: Moderate Oligosaccharide Group;Dietary Supplement: High Oligosaccharide Group | University of British Columbia | The Alfred;Melbourne Health | Terminated | 19 Years | N/A | All | 24 | N/A | Australia;Canada |
| 1028 | NCT02389790 (ClinicalTrials.gov) | August 2015 | 10/3/2015 | Extension Study of MT-1303 in Subjects With Crohn's Disease | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease Who Have Completed the MT 1303-E13 Study | Crohn's Disease | Drug: MT-1303 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 65 Years | All | 46 | Phase 2 | Czechia;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine;Czech Republic |
| 1029 | EUCTR2014-003855-76-BE (EUCTR) | 29/07/2015 | 19/05/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1030 | EUCTR2015-001179-36-PL (EUCTR) | 24/07/2015 | 01/06/2015 | Study to evaluate whether a fixed-dose of RHB-104 is safe and effective in subjects suffering from moderate to Severely Crohn’s disease. Subjects will be separated in two groups that will be treated in parallel to receive study drug or placebo. Neither the treating physician nor the subject will be aware of the actual treatment received. | A Phase III Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: RHB-104 INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: Rifabutin Other descriptive name: RIFABUTIN INN or Proposed INN: Clofazimine Other descriptive name: CLOFAZIMINE | RedHill Biopharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 324 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Czech Republic;Slovakia;Canada;Poland;Romania;Australia;Israel;Bulgaria;New Zealand | ||
| 1031 | EUCTR2014-003824-36-BE (EUCTR) | 17/07/2015 | 27/05/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1032 | EUCTR2014-003240-12-IT (EUCTR) | 16/07/2015 | 28/02/2018 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. - n/a | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg Other descriptive name: A-1293543.74 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1033 | EUCTR2014-002311-41-GB (EUCTR) | 14/07/2015 | 30/06/2015 | A prospective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheraPy and infliximab monothErapy in Crohn's disease patients in sustained steroid-free remission on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy (SPARE) - SPARE | Luminal Crohn's disease patients in steroid free remission for at least 6 months and on combination therapy with infliximab and antimetabolites for at least 1 year MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: Remicade Product Name: INFLIXIMAB Trade Name: Imuran Product Name: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate Trade Name: Mercaptopurine Product Name: Mercaptopurine | University of Edinburgh | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | France;Belgium;Germany;United Kingdom;Sweden | |||
| 1034 | EUCTR2014-003855-76-LV (EUCTR) | 02/07/2015 | 02/03/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1035 | EUCTR2014-003824-36-LV (EUCTR) | 02/07/2015 | 26/02/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | Bulgaria;Germany;New Zealand;Sweden;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of | ||
| 1036 | NCT02646683 (ClinicalTrials.gov) | July 2015 | 27/8/2015 | A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study | An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study (LOw Countries VEdolizumab in CD Study) | Crohn Disease | Drug: vedolizumab | Geert D'Haens | Takeda | Recruiting | 18 Years | 80 Years | All | 260 | Phase 4 | Belgium;Hungary;Netherlands |
| 1037 | NCT02269358 (ClinicalTrials.gov) | July 2015 | 30/9/2014 | Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation | Phase 4, Open Lable Non Randomized un Controlled Study. Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation | Crohn's Disease | Drug: METHOTREXATE | Prof. Arie Levine | NULL | Completed | 8 Years | 18 Years | All | 22 | Phase 4 | Israel |
| 1038 | EUCTR2014-003855-76-AT (EUCTR) | 30/06/2015 | 26/05/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1039 | EUCTR2014-005376-29-NL (EUCTR) | 29/06/2015 | 08/01/2015 | An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease. | An open-label observational phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Netherlands | ||
| 1040 | EUCTR2012-004222-25-GR (EUCTR) | 25/06/2015 | 26/06/2015 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2;Phase 3 | United States;Morocco;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Tunisia | ||
| 1041 | EUCTR2014-003509-13-CZ (EUCTR) | 25/06/2015 | 27/04/2015 | Effect of Vedolizumab IV in subjects with Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Vedolizumab IV (Entyvio™) Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Hungary;Czech Republic;Canada;Belgium;Poland | ||
| 1042 | EUCTR2014-003824-36-HR (EUCTR) | 24/06/2015 | 01/10/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1043 | EUCTR2014-003855-76-HR (EUCTR) | 24/06/2015 | 01/10/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Sweden;New Zealand;Germany;Bulgaria;Croatia;Romania;Brazil | ||
| 1044 | EUCTR2014-003240-12-ES (EUCTR) | 24/06/2015 | 27/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1045 | EUCTR2014-003824-36-SK (EUCTR) | 23/06/2015 | 04/05/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A Phase III, Randomized, Double-Blind, Placebo-Controlled, MulticenterStudy to Evaluate the Efficacy and Safety of Etrolizumab as an Inductionand Maintenance Treatment for Patients with Moderately to Severely ActiveCrohn´s Disease | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1046 | EUCTR2014-003855-76-SK (EUCTR) | 23/06/2015 | 07/05/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | An open-label extension and safety monitoring study of patients with moderately to severely active Crohn`s disease previously enrolled in the Etrolizumab phase III protocol GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1047 | EUCTR2014-003240-12-SK (EUCTR) | 22/06/2015 | 09/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1048 | EUCTR2014-003240-12-DE (EUCTR) | 22/06/2015 | 25/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1049 | EUCTR2014-003240-12-BE (EUCTR) | 19/06/2015 | 18/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1050 | EUCTR2014-003855-76-HU (EUCTR) | 15/06/2015 | 23/03/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1051 | EUCTR2014-003824-36-HU (EUCTR) | 15/06/2015 | 23/03/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1052 | EUCTR2014-001050-41-DE (EUCTR) | 12/06/2015 | 15/12/2014 | Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2 | A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2 | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: Humira | Robarts Clinical Trials | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 4 | United States;Canada;Germany;United Kingdom | ||
| 1053 | EUCTR2014-003240-12-DK (EUCTR) | 10/06/2015 | 31/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Denmark;Australia;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1054 | NCT02403323 (ClinicalTrials.gov) | June 8, 2015 | 26/3/2015 | Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144 | An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144 | Crohn Disease | Drug: Etrolizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | N/A | All | 900 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Luxembourg;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic |
| 1055 | EUCTR2013-004034-15-BE (EUCTR) | 04/06/2015 | 05/01/2015 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1056 | EUCTR2014-005376-29-BE (EUCTR) | 02/06/2015 | 03/02/2015 | An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease. | An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD | Active Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab | Academic Medical Center, Gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 4 | Belgium;Netherlands | ||
| 1057 | EUCTR2014-001645-24-PL (EUCTR) | 29/05/2015 | 06/05/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1058 | EUCTR2014-003824-36-ES (EUCTR) | 27/05/2015 | 27/03/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE | Crohn`s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Lithuania;Turkey;Austria;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of;Serbia;United States;Estonia;Slovakia;Spain;Ukraine | ||
| 1059 | EUCTR2014-003824-36-AT (EUCTR) | 27/05/2015 | 21/04/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Australia;South Africa;Latvia;Netherlands;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Czech Republic;Hungary;United Kingdom;Austria;Lithuania;Turkey;Korea, Republic of;France;Italy;Switzerland;Russian Federation;Israel;Ukraine;Spain;Slovakia;Estonia;Serbia;United States | ||
| 1060 | EUCTR2014-003855-76-ES (EUCTR) | 27/05/2015 | 27/03/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN?S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Latvia;New Zealand;Korea, Republic of | ||
| 1061 | EUCTR2014-003824-36-CZ (EUCTR) | 20/05/2015 | 31/03/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1062 | EUCTR2014-003509-13-HU (EUCTR) | 15/05/2015 | 13/04/2015 | Vedolizumab IV in subjects with Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease | Crohn's Disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Vedolizumab IV (Entyvio™) Product Name: Vedolizumab IV Product Code: MLN0002 | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Hungary;Canada;Belgium;Poland | ||
| 1063 | EUCTR2010-020137-10-LT (EUCTR) | 13/05/2015 | 12/03/2015 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1064 | EUCTR2014-003855-76-CZ (EUCTR) | 11/05/2015 | 12/05/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1065 | EUCTR2014-003240-12-HU (EUCTR) | 11/05/2015 | 25/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1066 | EUCTR2013-004034-15-FR (EUCTR) | 07/05/2015 | 22/06/2015 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1067 | EUCTR2014-003240-12-CZ (EUCTR) | 04/05/2015 | 07/05/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT- 494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 1068 | NCT02256462 (ClinicalTrials.gov) | May 1, 2015 | 26/9/2014 | Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial | Pediatric Crohn's Disease AdalImumab Level-based Optimization Treatment (PAILOT) Trial | Crohn's Disease | Drug: Adalimumab | Schneider Children's Medical Center, Israel | NULL | Completed | 6 Years | 17 Years | All | 82 | Phase 4 | Israel |
| 1069 | NCT02413047 (ClinicalTrials.gov) | May 2015 | 6/3/2015 | Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator | A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate | Indiana University | NULL | Terminated | 18 Years | 80 Years | All | 3 | N/A | United States |
| 1070 | NCT02423460 (ClinicalTrials.gov) | May 2015 | 12/4/2015 | Threonine Requirement in IBD Adults and Healthy Adult Controls | Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology | Ulcerative Colitis;Crohn's Disease;Healthy | Other: Threonine | Nestlé | The Hospital for Sick Children;Mount Sinai Hospital, Canada | Completed | 18 Years | 40 Years | Male | 86 | N/A | Canada |
| 1071 | NCT02405442 (ClinicalTrials.gov) | April 30, 2015 | 27/3/2015 | Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease | A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: Andecaliximab;Drug: Placebo | Gilead Sciences | NULL | Terminated | 18 Years | 75 Years | All | 187 | Phase 2 | United States;Australia;Canada;Czechia;France;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Czech Republic;Iceland |
| 1072 | NCT02539368 (ClinicalTrials.gov) | April 22, 2015 | 22/7/2015 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease | POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD) | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease | Drug: CT-P13;Drug: Remicade | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Completed | 18 Years | N/A | All | 2565 | Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland | |
| 1073 | EUCTR2014-003855-76-FR (EUCTR) | 17/04/2015 | 25/06/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Switzerland;France;Hungary;Mexico;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Latvia;New Zealand;Korea, Republic of | ||
| 1074 | EUCTR2014-003824-36-FR (EUCTR) | 17/04/2015 | 25/06/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Croatia;Germany;New Zealand;Sweden | ||
| 1075 | EUCTR2014-003855-76-EE (EUCTR) | 15/04/2015 | 17/02/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1250 | Phase 3 | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1076 | EUCTR2014-003824-36-EE (EUCTR) | 15/04/2015 | 17/02/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1250 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1077 | EUCTR2014-002557-19-NL (EUCTR) | 10/04/2015 | 03/11/2014 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy | ||
| 1078 | EUCTR2014-003855-76-LT (EUCTR) | 10/04/2015 | 18/02/2015 | An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease | AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144 | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Sweden | ||
| 1079 | EUCTR2014-003824-36-LT (EUCTR) | 10/04/2015 | 18/02/2015 | A Phase III study to assess whether etrolizumab is a safe and effective treatment for patients with moderately to severely active Crohn's disease | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB AS AN INDUCTION AND MAINTENANCE TREATMENT FOR PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE | Crohn`s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Product Name: Etrolizumab Product Code: Ro 549-0261/F08-02 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Sweden | ||
| 1080 | EUCTR2014-005702-37-NL (EUCTR) | 08/04/2015 | 12/02/2015 | Early infliximab use in kids with Crohn's disease (TISKids) | Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids) | Crohn's disease;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Other descriptive name: Inflectra | Erasmus Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Netherlands | ||
| 1081 | NCT02367183 (ClinicalTrials.gov) | April 8, 2015 | 13/2/2015 | A Randomized, Double-blind, Study to Explore the Effect of GED-0301 in Subjects With Active Crohn's Disease | A Randomized, Double-blind, Multicenter Study to Explore the Effect of GED-0301 on Endoscopic and Clinical Outcomes in Subjects With Active Crohn's Disease. | Crohn Disease | Drug: GED-0301;Drug: Placebo | Celgene | NULL | Completed | 18 Years | N/A | All | 64 | Phase 1 | United States;Australia;Canada;Hungary;Slovakia |
| 1082 | NCT02675153 (ClinicalTrials.gov) | April 1, 2015 | 21/1/2016 | To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture | Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture | Crohn's Diseases | Drug: Rapamycin | The Second Hospital of Nanjing Medical University | NULL | Recruiting | 18 Years | N/A | All | 15 | N/A | China |
| 1083 | NCT02517684 (ClinicalTrials.gov) | April 2015 | 1/7/2015 | Top-down Infliximab Study in Kids With Crohn's Disease | Top-down Infliximab Study in Kids With Crohn's Disease | Crohn's Disease | Drug: Infliximab;Drug: Prednisolone;Other: Exclusive enteral nutrition;Drug: Azathioprine | Erasmus Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development;Hospira, now a wholly owned subsidiary of Pfizer | Active, not recruiting | 3 Years | 17 Years | All | 100 | Phase 4 | Belgium;Finland;Netherlands;Denmark;Italy;Poland |
| 1084 | NCT02580617 (ClinicalTrials.gov) | April 2015 | 15/10/2015 | A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's Disease | A Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's Disease | Crohn's Disease | Biological: ALLO-ASC | Anterogen Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 9 | Phase 1 | Korea, Republic of |
| 1085 | NCT02851134 (ClinicalTrials.gov) | April 2015 | 7/6/2016 | Search for New Genetic Mutations Major Effect in Crohn's Disease | Search for New Genetic Mutations Major Effect in Crohn's Disease | Crohn Disease | Genetic: genetic analysis;Biological: blood and stools samples | University Hospital, Lille | NULL | Completed | 5 Years | 80 Years | All | 20 | France | |
| 1086 | NCT02208310 (ClinicalTrials.gov) | April 2015 | 1/8/2014 | Trial of High Dose Vitamin D in Patient's With Crohn's Disease | A Randomized Controlled Trial of High-Dose Vitamin D in Crohn's Disease | Crohn's Disease;Vitamin D Deficiency | Drug: Cholecalciferol 10,000 IU;Drug: Cholecalciferol 400 IU | University of Michigan | Crohn's and Colitis Foundation | Terminated | 18 Years | 75 Years | All | 11 | Phase 4 | United States |
| 1087 | EUCTR2013-004034-15-IT (EUCTR) | 31/03/2015 | 03/10/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1088 | NCT02425111 (ClinicalTrials.gov) | March 30, 2015 | 26/3/2015 | Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease | An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV | Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | 80 Years | All | 101 | Phase 3 | United States;Belgium;Canada;Czechia;France;Hungary;Italy;Poland;Czech Republic |
| 1089 | EUCTR2014-002556-77-PL (EUCTR) | 30/03/2015 | 20/01/2015 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | ||
| 1090 | EUCTR2014-002557-19-PL (EUCTR) | 30/03/2015 | 21/01/2015 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | ||
| 1091 | EUCTR2014-002556-77-NL (EUCTR) | 26/03/2015 | 03/11/2014 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Germany;Netherlands;Japan;Italy | ||
| 1092 | NCT02674308 (ClinicalTrials.gov) | March 24, 2015 | 29/1/2016 | Entyvio (Vedolizumab) Long Term Safety Study | Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis and Crohn's Disease | Drug: Vedolizumab;Other: Other Biologic Agents | Takeda | NULL | Completed | 18 Years | N/A | All | 5302 | United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom | |
| 1093 | NCT02394028 (ClinicalTrials.gov) | March 20, 2015 | 27/2/2015 | A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Etrolizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 1150 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czech Republic;Luxembourg;Sweden |
| 1094 | NCT03306446 (ClinicalTrials.gov) | March 17, 2015 | 21/6/2015 | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab | CD | Drug: Start adalimumab in monotherapy | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Active, not recruiting | 18 Years | 75 Years | All | 203 | Phase 4 | Belgium;France |
| 1095 | NCT02365649 (ClinicalTrials.gov) | March 17, 2015 | 16/2/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | Crohn's Disease | Drug: Placebo;Drug: ABT-494 | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 220 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom;United States |
| 1096 | EUCTR2014-001644-38-PL (EUCTR) | 13/03/2015 | 30/12/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1097 | EUCTR2013-004034-15-DK (EUCTR) | 06/03/2015 | 27/10/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1098 | NCT02378688 (ClinicalTrials.gov) | March 2015 | 27/2/2015 | Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: MT-1303;Drug: Placebo | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 18 Years | 65 Years | Both | 78 | Phase 2 | Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Slovakia;Ukraine |
| 1099 | NCT02392286 (ClinicalTrials.gov) | March 2015 | 12/3/2015 | Corticosteroid Dosage for Crohn's Disease Flare | A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares | Crohn's Disease;Inflammatory Bowel Disease | Drug: Corticosteroid | Yale University | NULL | Terminated | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 1100 | NCT01836289 (ClinicalTrials.gov) | March 2015 | 17/4/2013 | High-dose Cyclophosphamide for Severe Refractory Crohn Disease | High-dose Cyclophosphamide for Severe Refractory Crohn Disease | Crohn's Disease;Crohn Disease | Drug: High-dose Cyclophosphamide | Johns Hopkins University | NULL | Withdrawn | 18 Years | 100 Years | All | 0 | Phase 1/Phase 2 | United States |
| 1101 | EUCTR2013-002902-29-NL (EUCTR) | 12/02/2015 | 25/02/2014 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655066 10 mg/ml Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Name: BI 655066 90 mg/ml Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of | ||
| 1102 | EUCTR2014-001645-24-DE (EUCTR) | 09/02/2015 | 01/10/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1103 | EUCTR2013-004034-15-DE (EUCTR) | 09/02/2015 | 29/08/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1104 | EUCTR2014-001644-38-DE (EUCTR) | 02/02/2015 | 18/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1105 | NCT02321280 (ClinicalTrials.gov) | February 2015 | 11/12/2014 | The Efficacy of Denosumab in Active Crohn's Disease | Denosumab (A Monoclonal Antibody to Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL) in Crohn's Disease | Crohn Disease | Drug: Denosumab | University of Manitoba | University of Toronto;McMaster University | Completed | 18 Years | 80 Years | All | 2 | Phase 1/Phase 2 | Canada |
| 1106 | NCT02061163 (ClinicalTrials.gov) | February 2015 | 6/2/2014 | Contrast-Enhanced Ultrasound in Human Crohn's Disease | Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease | Crohn's Disease | Device: Contrast Enhanced Ultrasound;Drug: Optison | University of Michigan | NULL | Withdrawn | 10 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States |
| 1107 | EUCTR2013-004034-15-GB (EUCTR) | 27/01/2015 | 29/08/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1108 | EUCTR2014-002556-77-SK (EUCTR) | 20/01/2015 | 03/11/2014 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | ||
| 1109 | EUCTR2014-002557-19-SK (EUCTR) | 20/01/2015 | 03/11/2014 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy | ||
| 1110 | EUCTR2013-001746-33-FR (EUCTR) | 14/01/2015 | 22/06/2015 | A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1111 | EUCTR2013-001746-33-BE (EUCTR) | 12/01/2015 | 03/04/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab Doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1112 | EUCTR2014-001645-24-CZ (EUCTR) | 09/01/2015 | 30/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc subsidiary of Valeant Pharmaceuticals International Inc | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1113 | EUCTR2014-001644-38-CZ (EUCTR) | 09/01/2015 | 19/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. subsidiary of Valeant Pharmaceuticals International In | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1114 | EUCTR2014-002557-19-IT (EUCTR) | 03/01/2015 | 10/11/2014 | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy | ||
| 1115 | EUCTR2014-002556-77-IT (EUCTR) | 03/01/2015 | 11/11/2014 | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy | ||
| 1116 | NCT02272868 (ClinicalTrials.gov) | January 2015 | 16/10/2014 | Fecal Microbial Transplant in Pediatric Crohn's Disease | Fecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control Study | Crohn's Disease | Biological: Fecal Microbial transplant;Drug: Normal Saline;Drug: rifaximin+omeprazole+miralax | Seattle Children's Hospital | NULL | Terminated | 12 Years | 21 Years | All | 7 | Phase 1/Phase 2 | United States |
| 1117 | NCT02335281 (ClinicalTrials.gov) | January 2015 | 7/1/2015 | Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Procedure: FMT;Drug: Mesalazine | Yanling Wei | NULL | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China |
| 1118 | EUCTR2013-002902-29-DE (EUCTR) | 22/12/2014 | 08/08/2014 | Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: Risankizumab 10 mg/ml INN or Proposed INN: Risankizumab Product Code: Risankizumab 90 mg/ml INN or Proposed INN: Risankizumab | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 1119 | NCT02201693 (ClinicalTrials.gov) | December 12, 2014 | 17/7/2014 | Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease | Randomised Trial Comparing 12 Months of Cyclic Enteral Nutrition to Supplementary Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease | Crohn's Disease | Dietary Supplement: MODULEN IBD | Assistance Publique - Hôpitaux de Paris | GETAID Pediatric | Completed | 6 Years | 18 Years | All | 100 | N/A | France |
| 1120 | EUCTR2013-004034-15-AT (EUCTR) | 11/12/2014 | 12/11/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1121 | EUCTR2013-004034-15-SK (EUCTR) | 10/12/2014 | 13/10/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1122 | EUCTR2013-002838-20-BE (EUCTR) | 09/12/2014 | 15/09/2014 | The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease | The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: D-CURA Product Name: D-Cura INN or Proposed INN: Cholecalciferol Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM) | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | Belgium;Netherlands | ||
| 1123 | EUCTR2014-001892-30-HU (EUCTR) | 08/12/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's disease | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease | Crohn’s Disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Germany;United Kingdom;Russian Federation;France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine | ||
| 1124 | EUCTR2014-001644-38-FR (EUCTR) | 08/12/2014 | 22/06/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1125 | EUCTR2014-001295-65-AT (EUCTR) | 01/12/2014 | 19/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 1126 | EUCTR2014-001295-65-IT (EUCTR) | 01/12/2014 | 27/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 1127 | NCT02255370 (ClinicalTrials.gov) | December 2014 | 19/9/2014 | Curcumin Associated With Thiopurin in the Prevention of Post-op Recurrence in Crohn Disease | Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease | Crohn's Disease | Drug: Curcumin | University Hospital, Clermont-Ferrand | 3i nature;Naturopôle Nutrition santé | Completed | 18 Years | N/A | All | 61 | Phase 3 | France |
| 1128 | NCT02249078 (ClinicalTrials.gov) | December 2014 | 23/9/2014 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease | A Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: E6011;Drug: Placebo | Eisai Inc. | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1 | NULL |
| 1129 | NCT02327221 (ClinicalTrials.gov) | December 2014 | 23/12/2014 | Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease | A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease | Crohn Disease | Drug: Ovasave;Drug: Placebo | TxCell | NULL | Terminated | 18 Years | 70 Years | All | 32 | Phase 2 | Austria;Belgium;France;Germany;Italy;United Kingdom |
| 1130 | EUCTR2014-001295-65-BE (EUCTR) | 28/11/2014 | 17/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and parallel-group study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (Ova-Treg)) in patients with active refractory Crohn's Disease (Crohn's And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 117 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 1131 | EUCTR2013-001746-33-NL (EUCTR) | 28/11/2014 | 22/04/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands;Germany | ||
| 1132 | EUCTR2014-002557-19-CZ (EUCTR) | 27/11/2014 | 30/09/2014 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | ||
| 1133 | EUCTR2014-002556-77-CZ (EUCTR) | 27/11/2014 | 30/09/2014 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Israel;Netherlands;Germany;Japan;Italy | ||
| 1134 | EUCTR2014-001295-65-DE (EUCTR) | 25/11/2014 | 19/11/2014 | Phase II study evaluating Ovasave, a cell therapy, in patient with active Crohn's Disease | A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29 | Moderately to severely active Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Ovasave INN or Proposed INN: Ova-Treg Other descriptive name: Autologous ovalbumin-specific type 1 regulatory T lymphocytes expanded population | TxCell | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 2 | Belgium;Austria;Germany;Italy | ||
| 1135 | EUCTR2013-004034-15-ES (EUCTR) | 25/11/2014 | 22/09/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Denmark | ||
| 1136 | EUCTR2014-001892-30-BE (EUCTR) | 24/11/2014 | 18/09/2014 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate Crohn's disease | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Disease | Crohn’s Disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Other descriptive name: GLPG1205 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Russian Federation;Germany;United Kingdom | ||
| 1137 | EUCTR2014-002557-19-HU (EUCTR) | 18/11/2014 | 09/10/2014 | A clinical study to assess the safety and clinical effects of MT-1303 in subjects with moderate to severe active Crohn’s Disease who have completed the main MT-1303-E13 study | A Phase II, Open-label, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects with Moderate to Severe Active Crohn’s Disease who have Completed the MT-1303-E13 Study | Subjects with moderate to severe crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy | ||
| 1138 | EUCTR2014-001645-24-HU (EUCTR) | 18/11/2014 | 24/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1139 | EUCTR2014-002556-77-HU (EUCTR) | 18/11/2014 | 09/10/2014 | A clinical study to assess the safety, tolerability and clinical effects of MT 1303 in subjects with moderate to severe active Crohn’s Disease | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease | Subjects with moderate to severe crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: MT-1303 Product Code: MT-1303 INN or Proposed INN: MT-1303 | Mitsubishi Tanabe Pharma Corporation (MTPC) | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Poland;Israel;Netherlands;Germany;Japan;Italy | ||
| 1140 | EUCTR2014-001645-24-FR (EUCTR) | 18/11/2014 | 22/06/2015 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 18.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1141 | EUCTR2014-001644-38-HU (EUCTR) | 18/11/2014 | 17/09/2014 | A Study to Assess Treatment Efficacy and Safety of Rifaximin DR Twice Daily in Subjects with Active Crohn's Disease for 52 weeks. | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease | Treatment of active Crohn’s disease MedDRA version: 17.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin Delayed Release (DR) INN or Proposed INN: RIFAXIMIN | Salix Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 660 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Israel;Germany | ||
| 1142 | NCT02453607 (ClinicalTrials.gov) | November 17, 2014 | 21/5/2015 | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | The Impact of 6MP Metabolite Levels on Infliximab Pharmacokinetics and Anti-infliximab Antibodies in Crohn's Disease | Inflammatory Bowel Disease;Crohn's Disease | Drug: Infliximab;Drug: thiopurine | Ernest Seidman | University of Toronto;University of Calgary;University of Alberta | Recruiting | 18 Years | 70 Years | All | 225 | N/A | Canada |
| 1143 | EUCTR2014-000261-51-FR (EUCTR) | 04/11/2014 | 28/08/2015 | Randomized, controlled, double bind study, comparing curcumin to placebo, associated with thiopurines, in the the prevention of post-operative Crohn's desease relapse | POPCUR : a randomized, controlled, double bind study, comparing curcuma to placebo, associated with thiopurines, in the prevention of post-operative Crohn's disease recurrence - POPCUR | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Curcuma Other descriptive name: CURCUMA LONGA RHIZOMA | CHU de Clermont-Ferrand | NULL | Not Recruiting | Female: yes Male: yes | 122 | Phase 3 | France | ||
| 1144 | NCT02426567 (ClinicalTrials.gov) | November 2014 | 17/4/2015 | The Impact of Crohn's Disease-TReatment-with-EATing Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria | An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity | Crohn's Disease;Dietary Modification | Other: Exclusive Enteral Nutrition (EEN);Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet) | University of Glasgow | NULL | Completed | 18 Years | N/A | Both | 28 | N/A | United Kingdom |
| 1145 | EUCTR2013-004497-10-RO (EUCTR) | 31/10/2014 | 02/06/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 1146 | NCT02240108 (ClinicalTrials.gov) | October 28, 2014 | 11/9/2014 | One Year Study of Rifaximin Delayed Release (DR) in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Terminated | 18 Years | N/A | All | 81 | Phase 3 | United States |
| 1147 | EUCTR2013-001746-33-DK (EUCTR) | 23/10/2014 | 15/05/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1148 | EUCTR2013-001746-33-DE (EUCTR) | 08/10/2014 | 01/04/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses forInduction and Maintenance Therapy in Subjects with Moderately toSeverely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1149 | EUCTR2013-004034-15-HU (EUCTR) | 07/10/2014 | 25/08/2014 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability ofRepeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Ukraine;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany | ||
| 1150 | NCT02148640 (ClinicalTrials.gov) | October 2014 | 23/5/2014 | The NOR-SWITCH Study | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic | Drug: Innovator infliximab;Drug: Biosimilar infliximab | Diakonhjemmet Hospital | South-Eastern Norway Regional Health Authority | Completed | 18 Years | N/A | All | 482 | Phase 4 | Norway |
| 1151 | EUCTR2014-003141-10-BE (EUCTR) | 29/09/2014 | 26/09/2014 | Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie. | Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie. | Crohn's disease or colitis ulcerosa MedDRA version: 17.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: UrsoFalk® 250 mg tabletten. Product Name: UrsoFalk INN or Proposed INN: ursodeoxycholic acid Other descriptive name: URSODEOXYCHOLIC ACID | Ghent University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 4 | Belgium | ||
| 1152 | NCT02096861 (ClinicalTrials.gov) | September 19, 2014 | 24/3/2014 | Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease | Crohn's Disease | Biological: CT-P13;Biological: Remicade | Celltrion | Pfizer | Completed | 18 Years | 75 Years | All | 220 | Phase 3 | United States |
| 1153 | EUCTR2013-004497-10-GB (EUCTR) | 16/09/2014 | 23/05/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1154 | EUCTR2013-004497-10-DK (EUCTR) | 11/09/2014 | 02/06/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1155 | EUCTR2013-001746-33-IT (EUCTR) | 09/09/2014 | 10/04/2014 | A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1156 | NCT02154425 (ClinicalTrials.gov) | September 2014 | 30/5/2014 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
| 1157 | NCT02332356 (ClinicalTrials.gov) | September 2014 | 4/1/2015 | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease | Crohn Disease | Drug: azathioprine or adalimumab and infliximab | Tokyo Medical and Dental University | NULL | Recruiting | 16 Years | 65 Years | All | 100 | Phase 3 | Japan |
| 1158 | NCT02240121 (ClinicalTrials.gov) | August 21, 2014 | 11/9/2014 | One Year Study of Rifaximin Delayed Release (DR) Tablets in Crohn's Disease | A Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission With Endoscopic Response at 16 Weeks Followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: Rifaximin EIR;Drug: Placebo | Bausch Health Americas, Inc. | Salix Pharmaceuticals, Inc. a division of Bausch Health US, LLC | Terminated | 18 Years | N/A | All | 80 | Phase 3 | United States |
| 1159 | EUCTR2013-005629-21-HU (EUCTR) | 14/08/2014 | 11/06/2014 | Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease | Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease | Crohn’s disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab (Remicade): 100 mg of lyophilized infliximab INN or Proposed INN: INFLIXIMAB | First Department of Medicine, University of Szeged | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Hungary | ||||
| 1160 | NCT02185014 (ClinicalTrials.gov) | August 12, 2014 | 7/7/2014 | Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115 | A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 252 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;United States |
| 1161 | EUCTR2014-002056-40-NO (EUCTR) | 12/08/2014 | 13/06/2014 | A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH | Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858 MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning | Diakonhjemmet Hospital AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Norway | ||||
| 1162 | EUCTR2013-003199-11-FR (EUCTR) | 12/08/2014 | 26/03/2018 | CURE | Changing the coUrse of cRohn’s disease with an Early use of adalimumab: CURE STUDY - CURE | Crohn's disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: ADALIMUMAB Product Name: HUMIRA | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | France;Belgium | ||
| 1163 | EUCTR2013-004497-10-NL (EUCTR) | 06/08/2014 | 03/06/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1164 | EUCTR2013-004497-10-IT (EUCTR) | 01/08/2014 | 27/05/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1165 | NCT02000362 (ClinicalTrials.gov) | August 2014 | 7/11/2013 | Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD) | An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease | Crohn's Disease | Biological: Stem cells | Kang Stem Biotech Co., Ltd. | NULL | Recruiting | 19 Years | 70 Years | All | 24 | Phase 1/Phase 2 | Korea, Republic of |
| 1166 | EUCTR2013-004497-10-ES (EUCTR) | 25/07/2014 | 27/05/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn´s Disease | Active Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1167 | EUCTR2013-004497-10-BE (EUCTR) | 16/07/2014 | 12/05/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 18.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Denmark;Germany;Netherlands;Korea, Republic of | ||
| 1168 | EUCTR2013-001746-33-CZ (EUCTR) | 10/07/2014 | 15/05/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Netherlands | ||
| 1169 | EUCTR2013-004497-10-HU (EUCTR) | 02/07/2014 | 22/05/2014 | Demonstrating the non-inferiority in efficacy and safety of CT-P13 compared to Remicade in patients with active Crohn's Disease. | A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess the Safety of CT-P13 Compared to Remicade in Patients With Active Crohn’s Disease | Active Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB | Celltrion, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 214 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Netherlands;Germany;Korea, Republic of | ||
| 1170 | NCT02199561 (ClinicalTrials.gov) | July 2014 | 22/7/2014 | Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease | A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease | Crohn's Disease | Biological: Fecal Microbiota Transplant | University of Alberta | NULL | Completed | 18 Years | 65 Years | Both | 3 | Phase 1/Phase 2 | Canada |
| 1171 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 1172 | EUCTR2013-001746-33-ES (EUCTR) | 23/06/2014 | 25/04/2014 | A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1173 | EUCTR2013-001746-33-HU (EUCTR) | 18/06/2014 | 23/04/2014 | A Blinded Study to Evaluate the Efficacy and Safety of Two Adalimumab Doses in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | United States;Slovakia;Spain;Austria;Israel;Switzerland;France;Hungary;Czech Republic;European Union;Canada;Belgium;Denmark;Netherlands | |||
| 1174 | EUCTR2013-001746-33-SK (EUCTR) | 10/06/2014 | 15/04/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Netherlands;Germany;Denmark;Belgium;Canada;European Union;Czech Republic;Hungary;France;Italy;Switzerland;Israel;Austria;Spain;Slovakia;United States | ||
| 1175 | EUCTR2013-001746-33-AT (EUCTR) | 05/06/2014 | 15/05/2014 | A Blinded Study to Evaluate Higher Versus Standard Adalimumab doses for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;France;Czech Republic;Hungary;European Union;Canada;Belgium;Denmark;Germany;Netherlands | ||
| 1176 | NCT02179372 (ClinicalTrials.gov) | June 2014 | 29/6/2014 | Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases | Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases | Ulcerative Colitis;Crohn's Disease | Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo) | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | NULL | Completed | 18 Years | 80 Years | Both | 60 | N/A | Italy |
| 1177 | NCT02164877 (ClinicalTrials.gov) | June 2014 | 13/6/2014 | Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease | A Randomized, Controlled Study of Soluble Dietary Fiber on Bacterial Translocation in Adults Patients With Crohn's Disease | Crohn's Disease | Drug: pectin | Jinling Hospital, China | NULL | Terminated | 17 Years | 40 Years | All | 3 | Phase 2 | China |
| 1178 | NCT02148718 (ClinicalTrials.gov) | June 2014 | 23/5/2014 | Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease | Rapidity of Onset of Response to Adalimumab in Luminal Crohn's Disease (RAPIDA Study) | Moderate to Severe Crohn's Disease | Biological: adalimumab | AbbVie | Laboratorio Echevarne;Pivotal S.L. | Completed | 18 Years | 75 Years | All | 100 | Phase 4 | Spain |
| 1179 | NCT02065570 (ClinicalTrials.gov) | May 1, 2014 | 17/2/2014 | Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration | Crohn's Disease | Drug: Adalimumab;Drug: Placebo | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 514 | Phase 3 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic |
| 1180 | NCT02148185 (ClinicalTrials.gov) | May 2014 | 20/5/2014 | Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease | A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: MT-1303 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 65 Years | Both | 1 | Phase 1 | Japan |
| 1181 | NCT01881464 (ClinicalTrials.gov) | May 2014 | 11/6/2013 | Anti TNF a Improves Endothelial Dysfunction in IBD Patients | Anti TNF a Improves Endothelial Dysfunction in IBD Patients | Crohn's Disease | Device: Endopath from Itamar medical - FDA approved device.;Drug: Anti TNF Alfa. | Carmel Medical Center | NULL | Recruiting | 18 Years | 40 Years | Both | 20 | Israel | |
| 1182 | EUCTR2012-004222-25-SK (EUCTR) | 28/04/2014 | 09/01/2014 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Morocco;Slovakia;Greece;Belgium;Spain;Tunisia;India | ||
| 1183 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 1184 | EUCTR2013-004781-34-ES (EUCTR) | 16/04/2014 | 25/02/2014 | Rapidity of response to adalimumab treatment in patients with Crohn´s Disease. | Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study. | Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: ADALIMUMAB INN or Proposed INN: ADALIMUMAB | AbbVie Farmacéutica S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 4 | Spain | ||
| 1185 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1186 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 1187 | EUCTR2013-002857-32-PL (EUCTR) | 02/04/2014 | 03/02/2014 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Hungary;Czech Republic;Belgium;Poland;Romania;Russian Federation;Germany;United Kingdom | |||
| 1188 | EUCTR2013-001029-17-NL (EUCTR) | 01/04/2014 | 17/05/2013 | Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration | Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 1189 | NCT01960426 (ClinicalTrials.gov) | April 2014 | 25/9/2013 | Evaluation of Health Costs and Resource Utilization | A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease. | Ulcerative Colitis;Crohn's Disease | Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug | University of Western Ontario, Canada | Prometheus Laboratories | Terminated | 18 Years | N/A | Both | 51 | Phase 4 | United States |
| 1190 | NCT02913508 (ClinicalTrials.gov) | April 2014 | 22/9/2016 | Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease | A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab intravenous injection;Drug: Vedolizumab subcutaneous injection | Takeda | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 2 | NULL |
| 1191 | EUCTR2013-002857-32-GB (EUCTR) | 18/03/2014 | 05/11/2013 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | ||
| 1192 | EUCTR2011-000722-30-SE (EUCTR) | 17/03/2014 | 13/02/2014 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1193 | NCT02039063 (ClinicalTrials.gov) | March 14, 2014 | 9/1/2014 | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease | Crohn's Disease | Drug: E6011 10 mg/kg;Drug: E6011 15 mg/kg;Drug: E6011 2 mg/kg;Drug: E6011 5 mg/kg | EA Pharma Co., Ltd. | NULL | Completed | 20 Years | 64 Years | All | 28 | Phase 1/Phase 2 | Japan |
| 1194 | EUCTR2013-002651-15-NL (EUCTR) | 03/03/2014 | 18/09/2013 | Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood. | Adjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot - ILIST-study | Crohns diseaseUlcerative colitis MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade (infliximab) Product Name: infliximab | Zon MW | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 1195 | NCT02088944 (ClinicalTrials.gov) | March 2014 | 13/3/2014 | a Single-center Registered Clinical Research of Chinese Patients With Moderate to Severe Crohn's Disease | Serological C Reactive Protein or Erythrocyte Sedimentation Rate | Drug: Infliximab | Nanfang Hospital of Southern Medical University | NULL | Not yet recruiting | 18 Years | 75 Years | Both | 142 | N/A | NULL | |
| 1196 | NCT02108821 (ClinicalTrials.gov) | March 2014 | 21/3/2014 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh;Stanford University | Completed | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
| 1197 | NCT02281916 (ClinicalTrials.gov) | March 2014 | 28/10/2014 | Safety Study of P28GST Treatment in Crohn's Disease Patients | Safety Study of P28GST Treatment in Crohn's Disease Patients, a Multicenter Phase 2 Clinical Trial | Crohn's Ileocolitis | Drug: P28GST | University Hospital, Lille | National Research Agency, France;Institut National de la Santé Et de la Recherche Médicale, France | Completed | 18 Years | N/A | All | 10 | Phase 2 | France |
| 1198 | EUCTR2013-002857-32-DE (EUCTR) | 20/02/2014 | 30/10/2013 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | ||
| 1199 | NCT01986127 (ClinicalTrials.gov) | February 14, 2014 | 9/10/2013 | Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients | A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients | Crohn's Disease | Drug: Adalimumab;Drug: placebo | Sara Varea | Hospital Clinic of Barcelona | Terminated | 18 Years | N/A | All | 26 | Phase 3 | Spain |
| 1200 | NCT02060318 (ClinicalTrials.gov) | February 11, 2014 | 10/2/2014 | Regulatory T-cells and Crohn's Disease | The Effect of Infliximab Therapy in Crohn Patients on Regulatory T-cells | Crohn Disease | Drug: Infliximab | Hvidovre University Hospital | NULL | Completed | 18 Years | N/A | All | 47 | N/A | Denmark |
| 1201 | EUCTR2013-002857-32-BE (EUCTR) | 03/02/2014 | 07/11/2013 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | |||
| 1202 | EUCTR2013-002902-29-IE (EUCTR) | 03/02/2014 | 28/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 1203 | NCT01783106 (ClinicalTrials.gov) | February 1, 2014 | 31/1/2013 | Antibiotics and Hydroxychloroquine in Crohn's | A Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease | Crohn's Disease | Drug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: Budesonide | Royal Liverpool University Hospital | National Association for Colitis and Crohn's Disease;National Institute for Health Research, United Kingdom | Completed | 18 Years | N/A | All | 59 | Phase 2 | United Kingdom |
| 1204 | NCT02048618 (ClinicalTrials.gov) | February 2014 | 27/1/2014 | Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease | Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration | Crohn's Disease | Drug: GLPG0634;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 75 Years | Both | 175 | Phase 2 | Belgium;Czech Republic;France;Germany;Hungary;Poland;Romania;Russian Federation;United Kingdom |
| 1205 | NCT01932658 (ClinicalTrials.gov) | February 2014 | 28/6/2013 | Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment | Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment | Crohn's Disease | Biological: Hematopoietic stem cell transplantation | University of California, Los Angeles | NULL | Withdrawn | 7 Years | 70 Years | Both | 0 | Phase 0 | United States |
| 1206 | NCT02031276 (ClinicalTrials.gov) | February 2014 | 16/12/2013 | Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy | Crohn Disease | Drug: risankizumab IV;Drug: risankizumab SC;Drug: Placebo | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States |
| 1207 | JPRN-JapicCTI-142402 | 28/1/2014 | 27/12/2013 | Phase III study of MLN0002 (300 mg) in treatment of Crohn's disease | Phase III, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe Crohn's disease | Crohn's disease | Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Vedolizumab (300 mg) administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Vedolizumab Placebo administered by intravenous infusion at Weeks 0, 2, and 6 and every 8 weeks thereafter. | Takeda Pharmaceutical Company Limited | NULL | complete | 15 | 80 | BOTH | 157 | Phase 3 | Japan |
| 1208 | NCT02038920 (ClinicalTrials.gov) | January 28, 2014 | 15/1/2014 | Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease | Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease | Crohn's Disease | Drug: Vedolizumab;Drug: Vedolizumab placebo | Takeda | NULL | Completed | 15 Years | 80 Years | All | 157 | Phase 3 | Japan |
| 1209 | EUCTR2013-002857-32-CZ (EUCTR) | 21/01/2014 | 04/11/2013 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | ||
| 1210 | EUCTR2012-005226-29-PL (EUCTR) | 16/01/2014 | 19/09/2013 | Antibiotic therapy for children with active Crohn's disease | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: azithromycin Trade Name: metronidazole Product Name: metronidazole Product Name: azithromycin Product Name: azithromycin | Erasmus MC | Hospital S. Joao;University hospital Brussel;Jagiellonian University Medical College | Not Recruiting | Female: yes Male: yes | 70 | Portugal;United States;Canada;Belgium;Poland;Israel;Netherlands | |||
| 1211 | EUCTR2013-002857-32-HU (EUCTR) | 16/01/2014 | 04/11/2013 | A Study to Investigate the Efficacy and Safety of the study drug, GLPG0634, in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration | Crohn’s Disease With Evidence of Mucosal Ulceration MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0634 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 180 | France;Czech Republic;Hungary;Poland;Belgium;Romania;Russian Federation;Germany;United Kingdom | |||
| 1212 | EUCTR2013-002902-29-ES (EUCTR) | 09/01/2014 | 05/12/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of | ||
| 1213 | EUCTR2013-002902-29-BE (EUCTR) | 09/01/2014 | 20/09/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 1214 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 1215 | NCT04606017 (ClinicalTrials.gov) | January 1, 2014 | 25/10/2020 | Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease | Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study | Crohn Disease;Vitamin D Deficiency;Vitamin D Supplement | Drug: Caltrate Pill | Second Affiliated Hospital of Wenzhou Medical University | NULL | Completed | 18 Years | N/A | All | 70 | China | |
| 1216 | NCT02044952 (ClinicalTrials.gov) | January 2014 | 19/1/2014 | Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission | Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission | Inflammatory Bowel Diseases;Crohn's Disease;Gastrointestinal Diseases;Digestive System Diseases;Intestinal Diseases | Drug: Mesalazine, Tripterygium glycosides | Zhu Weiming | NULL | Recruiting | 18 Years | 75 Years | Both | 40 | Phase 2/Phase 3 | China |
| 1217 | NCT02019602 (ClinicalTrials.gov) | January 2014 | 18/12/2013 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | All | 37 | Phase 1 | United States;France;Netherlands;Switzerland |
| 1218 | NCT02349594 (ClinicalTrials.gov) | January 2014 | 16/1/2015 | Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease | Modulation of Immune Function by Parenteral Fish Oil in Patients With Crohn's Disease and High Inherent Tumor Necrosis Factor-alpha Production: a Randomized, Single Blinded, Cross-over Study | Crohn Disease | Drug: Omegaven 10%;Drug: Intralipid 20% | Radboud University | NULL | Completed | 18 Years | 70 Years | Both | 6 | Phase 4 | Netherlands |
| 1219 | NCT02615288 (ClinicalTrials.gov) | January 2014 | 23/11/2015 | High Dose Vitamin D3 in Crohn's Disease | Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study | Crohn's Disease | Dietary Supplement: Vitamin D3 | McMaster University | Canadian Association of Gastroenterology | Completed | 18 Years | 70 Years | Both | 40 | N/A | NULL |
| 1220 | EUCTR2012-005226-29-PT (EUCTR) | 20/12/2013 | 24/09/2013 | Antibiotic therapy for children with active Crohn's disease | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: azithromycin INN or Proposed INN: azithromycin Other descriptive name: AZITHROMYCIN Trade Name: metronidazole Product Name: metronidazole INN or Proposed INN: METRONIDAZOLE Other descriptive name: Metronidazole | Centro Hospitalar de São João E.P.E. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Portugal;Canada;Poland;Belgium;Israel;Netherlands | ||
| 1221 | EUCTR2013-002902-29-GB (EUCTR) | 10/12/2013 | 26/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 1222 | EUCTR2011-001332-29-AT (EUCTR) | 02/12/2013 | 07/11/2013 | The degradation and elimination of Infliximab | Pharmacokinetics of Infliximab | Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remicade | Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 1223 | NCT02015793 (ClinicalTrials.gov) | December 2013 | 13/12/2013 | Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease | A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein | Crohn's Disease | Biological: Adalimumab;Biological: Placebo for adalimumab | AbbVie | NULL | Completed | 18 Years | 70 Years | All | 30 | Phase 2 | China |
| 1224 | EUCTR2010-023034-23-SE (EUCTR) | 29/11/2013 | 01/11/2013 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1225 | EUCTR2012-004222-25-BE (EUCTR) | 26/11/2013 | 14/01/2013 | Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's disease | A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease | Crohn's disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Central African Republic;Slovakia;Greece;Spain;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;South Africa;Netherlands;Tunisia;Germany | ||
| 1226 | EUCTR2011-000722-30-AT (EUCTR) | 19/11/2013 | 15/10/2013 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1227 | EUCTR2013-002838-20-NL (EUCTR) | 12/11/2013 | 06/09/2013 | The effect of Vitamin D to prevent post-operative relapse of Crohn's Disease | The effect of Vitamin D3 to prevent post-operative relapse of Crohn’s Disease: a placebo-controlled randomized trial (DETECT) - DETECT | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: InVita D3 INN or Proposed INN: Colecalciferol Other descriptive name: CHOLECALCIFEROL CONCENTRATE | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 3 | Belgium;Netherlands | ||
| 1228 | EUCTR2011-003622-27-NL (EUCTR) | 30/10/2013 | 19/02/2013 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib Other descriptive name: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Sweden | ||
| 1229 | EUCTR2010-023034-23-AT (EUCTR) | 10/10/2013 | 20/08/2013 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1230 | NCT02859675 (ClinicalTrials.gov) | October 7, 2013 | 28/7/2016 | Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease | Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease | Crohn's Disease;Olfactogustatory Perception | Other: triangular test;Biological: blood sampling;Other: Questionnaires | Centre Hospitalier Universitaire Dijon | NULL | Recruiting | 18 Years | 60 Years | Female | 75 | France | |
| 1231 | EUCTR2012-001723-12-ES (EUCTR) | 07/10/2013 | 14/08/2013 | adalimumab intralesional in intestinal strictures of Crohn's disease patients | A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients | Crohn disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Humira Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Fundació Clínic per a la Recerca Biomèdica | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | Spain | ||
| 1232 | NCT01674413 (ClinicalTrials.gov) | October 2013 | 16/8/2012 | Calprotectin-Directed Humira® Maintenance Therapy (CADHUM) | Calprotectin-Directed Humira® Maintenance Therapy, a Double-blind, Double-dummy, Randomized Controlled Trial in Crohn's Disease | Crohn's Disease | Drug: Adalimumab;Drug: Adalimumab PRN;Drug: Placebo | Peter Higgins | AbbVie | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States |
| 1233 | NCT02538757 (ClinicalTrials.gov) | October 2013 | 18/8/2015 | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE) | Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Active, not recruiting | 50 Years | N/A | All | 125 | Phase 2 | United States |
| 1234 | EUCTR2012-000645-13-BE (EUCTR) | 09/09/2013 | 16/07/2013 | Infliximab as firsdt treatment instead of second line treatment in Crohns disease | Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Belgium;Netherlands | |||
| 1235 | JPRN-JapicCTI-142426 | 01/9/2013 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | Crohn's Disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : adalimumab 80mg every other week Control intervention name : null | AbbVie GK | NULL | 15 | BOTH | 28 | Phase 3 | NULL | |||
| 1236 | NCT01958827 (ClinicalTrials.gov) | September 2013 | 4/10/2013 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: Adalimumab | AbbVie | NULL | Completed | 15 Years | N/A | All | 28 | Phase 3 | Japan |
| 1237 | NCT01951326 (ClinicalTrials.gov) | September 2013 | 19/9/2013 | Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease | A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: RHB-104;Drug: Placebo | RedHill Biopharma Limited | NULL | Completed | 18 Years | 75 Years | All | 331 | Phase 3 | United States;Australia;Bulgaria;Canada;Czechia;Israel;New Zealand;Poland;Serbia;Slovakia;Czech Republic |
| 1238 | EUCTR2011-001754-28-HR (EUCTR) | 22/08/2013 | 28/08/2014 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Czech Republic;Hungary;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1239 | EUCTR2013-002932-25-NL (EUCTR) | 21/08/2013 | 25/07/2013 | A randomized clinical trial: treatment of perianal fistulas in Crohn's disease | Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 1240 | EUCTR2011-003622-27-HR (EUCTR) | 20/08/2013 | 28/08/2014 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1241 | EUCTR2011-001733-16-HR (EUCTR) | 19/08/2013 | 28/08/2014 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1242 | EUCTR2013-000971-34-DK (EUCTR) | 01/08/2013 | 01/08/2013 | High dose vitamin D treatment in Crohn's disease affects the gut immune cells | Mucosal immune regulation by high dose vitamin D treatment in Crohn’s disease - MirViDiC | Active Crohn's Disease in colon and/or terminal ileum MedDRA version: 19.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Dekristol 20.000 ie INN or Proposed INN: cholecalciferol Other descriptive name: CHOLECALCIFEROL Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB | Jørgen Agnholt | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark | ||
| 1243 | NCT01523106 (ClinicalTrials.gov) | August 2013 | 18/1/2012 | L-carnitine to Treat Fatigue Associated With Crohn's Disease | L-carnitine to Treat Fatigue Associated With Crohn's Disease | Crohn's Disease;Fatigue | Drug: L-carnitine;Other: Placebo | University of California, San Francisco | NULL | Withdrawn | 18 Years | 70 Years | Both | 0 | N/A | United States |
| 1244 | EUCTR2013-001212-30-NL (EUCTR) | 04/07/2013 | 18/06/2013 | Immune modulation by parenteral Fish oil in patients with Crohn’s disease | Modulation of immune function by parenteral fish oil in patients with Crohn’s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Omegaven Trade Name: Intralipid 10% | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | |||||
| 1245 | ChiCTR-DDT-14004999 | 2013-07-01 | 2014-07-17 | Endoscopic Ultrasonography (EUS) Helps Differentiate Crohn's Disease from Intestinal Tuberculosis | Endoscopic Ultrasonography (EUS) Helps Differentiate Crohn's Disease from Intestinal Tuberculosis | Crohn's disease and intestinal tuberculosis | Gold Standard:;Index test:; | West China Hospital, Sichuan University | NULL | Completed | 16 | 41 | Both | Target condition:0;Difficult condition:0 | China | |
| 1246 | NCT01864616 (ClinicalTrials.gov) | July 2013 | 22/5/2013 | The Impact of Vitamin D on Disease Activity in Crohn's Disease | Crohn Disease | Dietary Supplement: Vitamin D3 | University of Saskatchewan | Dania Alrefai;Dr.Jennifer Jones;Dr.Hani Jawa;Dr.Wael El-matary;Saudi Arabian Cultural Bureau | Terminated | 16 Years | 70 Years | All | 9 | N/A | Canada;Saudi Arabia | |
| 1247 | NCT01915927 (ClinicalTrials.gov) | July 2013 | 31/7/2013 | Stem Cell Fistula Plug in Perianal Crohn's Disease | A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease. | Perianal Crohn's Disease | Drug: MSC-AFP | William A. Faubion, M.D. | NULL | Completed | 18 Years | 65 Years | All | 20 | Phase 1 | United States |
| 1248 | NCT01947010 (ClinicalTrials.gov) | July 2013 | 9/9/2013 | Pneumococcal Vaccination of Crohn Patients | Pneumococcal Vaccination of Crohn Patients - A Randomized, Non-blinded Phase 4 Clinical Trial With the Purpose of Investigating the Immune Response Against Two Different Pneumococcal Vaccines in Patients With Crohn's Disease | Crohns Disease | Biological: Prevenar 13;Biological: Pneumovax | Statens Serum Institut | Hvidovre University Hospital;Herlev Hospital | Completed | 18 Years | N/A | Both | 151 | Phase 4 | Denmark |
| 1249 | NCT02887287 (ClinicalTrials.gov) | July 2013 | 29/8/2016 | Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease | Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment | Drug: EEN | Sun Yat-sen University | NULL | Completed | 18 Years | 60 Years | Both | 48 | N/A | China | |
| 1250 | EUCTR2010-022383-12-BG (EUCTR) | 13/06/2013 | 20/05/2013 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1251 | EUCTR2010-022384-35-BG (EUCTR) | 13/06/2013 | 28/05/2013 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1252 | EUCTR2011-003622-27-AT (EUCTR) | 04/06/2013 | 18/03/2013 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1253 | EUCTR2011-002817-12-BG (EUCTR) | 03/06/2013 | 20/05/2013 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand | |||
| 1254 | NCT01827631 (ClinicalTrials.gov) | May 27, 2013 | 5/4/2013 | Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects | Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects | Crohn's Disease | Drug: GSK1605786 capsule | GlaxoSmithKline | NULL | Completed | 18 Years | 45 Years | All | 21 | Phase 1 | China |
| 1255 | NCT01847170 (ClinicalTrials.gov) | May 2013 | 2/5/2013 | Impact of Fecal Biotherapy (FBT) on Microbial Diversity in Patients With Moderate to Severe Inflammatory Bowel Disease | Crohn's Disease | Biological: Fecal Microbial Transplantation | Beth Israel Deaconess Medical Center | The Broad Foundation;Brigham and Women's Hospital | Completed | 18 Years | N/A | All | 22 | Phase 1 | United States | |
| 1256 | NCT02073526 (ClinicalTrials.gov) | May 2013 | 9/1/2014 | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Infliximab, adalimumab, certolizumab pegol | Oslo University Hospital | NULL | Completed | 18 Years | N/A | Both | 1230 | N/A | Norway |
| 1257 | NCT02233062 (ClinicalTrials.gov) | May 2013 | 1/9/2014 | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Patients With Crohn's Disease | Impact of Exclusive Enteral Nutrition Therapy on Sperm Quality of Male Patients With Crohn's Disease | Crohn's Disease | Dietary Supplement: Exclusive Enteral Nutrition Therapy | Jinling Hospital, China | NULL | Completed | 18 Years | 40 Years | Male | 12 | N/A | China |
| 1258 | EUCTR2012-005226-29-BE (EUCTR) | 26/04/2013 | 14/03/2013 | Antibiotic therapy for children with active Crohn's disease | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: azithromycin Trade Name: metronidazole Product Name: metronidazole | Wolfson Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Portugal;United States;Canada;Poland;Belgium;Israel;Netherlands | |||
| 1259 | EUCTR2012-002432-93-BG (EUCTR) | 24/04/2013 | 05/03/2013 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria;United States;Serbia | |||
| 1260 | EUCTR2011-002817-12-NL (EUCTR) | 19/04/2013 | 07/11/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1261 | EUCTR2012-004098-26-DE (EUCTR) | 17/04/2013 | 03/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 1262 | EUCTR2012-004098-26-FR (EUCTR) | 10/04/2013 | 25/09/2015 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 1263 | NCT02676622 (ClinicalTrials.gov) | April 2013 | 21/4/2013 | Autologous Stem Cell Transplant for Refractory Crohn's Disease | A Pilot Study of Autologous Hematopoietic Stem Cell Transplantation With Post-Transplant Ultra Low-Dose IL-2 for Refractory Crohn's Disease | Crohn's Disease | Drug: mobilization of stem cells to prepare for Leukapheresis;Other: Leukapheresis- Collection of stem cells;Drug: Preparative regimen 4-6 weeks after Leukapheresis;Other: Stem Cell Transplant;Drug: Low-dose IL-2 administration | Nationwide Children's Hospital | NULL | Withdrawn | 12 Years | 29 Years | All | 0 | Phase 2 | NULL |
| 1264 | NCT01804166 (ClinicalTrials.gov) | March 21, 2013 | 1/2/2013 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | NULL | Completed | N/A | N/A | All | 1 | Phase 4 | United States |
| 1265 | EUCTR2011-002640-27-DE (EUCTR) | 08/03/2013 | 23/08/2012 | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis) | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY | ACTIVE CROHN'S DISEASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: 40 mg INN or Proposed INN: NA Other descriptive name: GED-0301 Product Name: GED-0301 Product Code: 10 mg INN or Proposed INN: NA Other descriptive name: GED-0301 | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Germany;Italy | ||
| 1266 | NCT01826188 (ClinicalTrials.gov) | March 2013 | 28/3/2013 | Combined THC and CBD Drops for Treatment of Crohn's Disease | Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial | Crohn's Disease | Drug: THC 5mg/ml and CBS 50mg/ml;Drug: Placebo | Meir Medical Center | NULL | Completed | 20 Years | 85 Years | All | 50 | Phase 1/Phase 2 | Israel |
| 1267 | NCT01810185 (ClinicalTrials.gov) | March 2013 | 11/3/2013 | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Low dose naltrexone;Drug: Placebo | Santa Barbara Cottage Hospital | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |
| 1268 | NCT01828190 (ClinicalTrials.gov) | March 2013 | 8/4/2013 | The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers | Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers | Crohn's Disease;Perianal Fistulas | Other: Hyperbaric oxygen | Assaf-Harofeh Medical Center | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | N/A | Israel |
| 1269 | NCT01769755 (ClinicalTrials.gov) | March 2013 | 15/1/2013 | A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease | Crohns Disease | Biological: PDA001;Drug: Vehicle Controlled Placebo | Celularity Incorporated | NULL | Completed | 18 Years | 75 Years | All | 14 | Phase 1 | United States |
| 1270 | NCT01817972 (ClinicalTrials.gov) | March 2013 | 19/3/2013 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Certolizumab pegol;Drug: Azathioprine | Gastroenterology Research of America | UCB Pharma | Not yet recruiting | 18 Years | 70 Years | Both | 65 | Phase 3 | United States |
| 1271 | NCT01809275 (ClinicalTrials.gov) | March 2013 | 8/3/2013 | Safety and Treatment Effect of QBECO in Moderate to Severe Crohn's Disease | A Phase 1/2 Randomized, Placebo-Controlled, Double-Blind Study of the Induction of Clinical Response and Remission by QBECO in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Drug: QBECO;Drug: Placebo | Qu Biologics Inc. | NULL | Completed | 18 Years | N/A | Both | 68 | Phase 1/Phase 2 | Canada |
| 1272 | EUCTR2012-004098-26-IT (EUCTR) | 25/02/2013 | 11/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active,moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 inSubjects with Moderate to Severe Crohn's Disease Who Have Failed or AreIntolerant to Anti-tumor Necrosis Factor-alpha Therapy - MEDI 2070 | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Product Code: MEDI2070 Other descriptive name: anticorpo monoclonale anti IL-23 | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy;France;United States;Hungary;Czech Republic;Canada | ||
| 1273 | EUCTR2012-002867-86-DK (EUCTR) | 13/02/2013 | 12/02/2013 | Prevention of serious pneumococcal infections in people with Crohn's disease | Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac | Crohn's Disease MedDRA version: 15.1;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Pnemovax Product Name: Pneumovax Trade Name: Prevenar 13 Product Name: Prevenar 13 | Statens Serum Institut | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 1274 | EUCTR2012-004098-26-HU (EUCTR) | 11/02/2013 | 11/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Czech Republic;Hungary;Canada;Spain;Poland;Germany;Italy | ||
| 1275 | EUCTR2012-004098-26-CZ (EUCTR) | 08/02/2013 | 07/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn's disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn’s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Spain;Poland;Germany;Italy | ||
| 1276 | EUCTR2012-002432-93-PL (EUCTR) | 06/02/2013 | 09/01/2013 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Bulgaria | |||
| 1277 | NCT01768858 (ClinicalTrials.gov) | February 5, 2013 | 14/1/2013 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Completed | 18 Years | 99 Years | All | 96 | Austria | |
| 1278 | EUCTR2011-002817-12-DE (EUCTR) | 05/02/2013 | 06/11/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan | |||
| 1279 | NCT01714726 (ClinicalTrials.gov) | February 1, 2013 | 24/10/2012 | Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn's Disease | Drug: MEDI2070;Drug: placebo | Allergan | NULL | Completed | 18 Years | 65 Years | All | 121 | Phase 2 | United States;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Spain;Czech Republic |
| 1280 | NCT01540292 (ClinicalTrials.gov) | February 1, 2013 | 22/2/2012 | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders | Crohn's Disease | Biological: Mesenchymal Stem Cells (MSC) | University of Liege | NULL | Terminated | 18 Years | 75 Years | All | 13 | Phase 1/Phase 2 | Belgium |
| 1281 | NCT01802593 (ClinicalTrials.gov) | February 2013 | 24/12/2012 | Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure | Phase 4, Open Label Multicenter Randomized Controlled Trial. Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Immunomodulator Failure | Crohn's Disease | Drug: AZATHIOPRINE or METHOTREXATE | Prof. Arie Levine | NULL | Terminated | 6 Years | 18 Years | Both | 20 | Phase 4 | Israel |
| 1282 | NCT01751152 (ClinicalTrials.gov) | February 2013 | 13/12/2012 | A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease | A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's Disease | Inflammation;Crohn's Disease | Drug: NNC0114-0006;Drug: placebo | Novo Nordisk A/S | NULL | Completed | 18 Years | 75 Years | All | 53 | Phase 2 | United States;Bulgaria;Czech Republic;Poland;Slovakia;Spain;Russian Federation;Serbia |
| 1283 | NCT01765998 (ClinicalTrials.gov) | February 2013 | 6/1/2013 | The Effect of Probiotics on Exacerbation of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation (Crohn's Disease) and Markers of Inflammation | Crohn's Disease | Drug: Probiotic;Drug: Placebo | The Baruch Padeh Medical Center, Poriya | NULL | Not yet recruiting | 18 Years | 60 Years | Both | 60 | Phase 4 | Israel |
| 1284 | NCT01874015 (ClinicalTrials.gov) | February 2013 | 6/6/2013 | Transplantation of Bone Marrow Mesenchymal Stem Cell in Crohn's Disease | Transplantation of Bone Marrow Mesenchymal Stem Cell in Moderate to Severe Fistulizing Crohn's Disease | Crohn's Disease | Biological: mesenchymal cell transplantation;Biological: mesenchymal cell and fibroblast injection | Royan Institute | NULL | Recruiting | 18 Years | 65 Years | All | 10 | Phase 1 | Iran, Islamic Republic of |
| 1285 | NCT01696942 (ClinicalTrials.gov) | February 2013 | 25/9/2012 | Cimzia Versus Mesalamine for Crohn's Recurrence | Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine | Crohn's Disease | Drug: Cimzia;Drug: Mesalamine | Milton S. Hershey Medical Center | UCB Pharma | Terminated | 18 Years | N/A | All | 10 | Phase 4 | United States |
| 1286 | NCT02010762 (ClinicalTrials.gov) | February 2013 | 10/12/2013 | The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease | The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease: a Placebo-controlled Randomized Trial | Crohn's Disease | Drug: Vitamin D;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | NULL | Completed | 18 Years | N/A | All | 142 | Phase 4 | Netherlands |
| 1287 | EUCTR2012-002432-93-SK (EUCTR) | 29/01/2013 | 28/03/2013 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohns disease MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Russian Federation | |||
| 1288 | EUCTR2012-004098-26-ES (EUCTR) | 28/01/2013 | 22/01/2013 | Evaluation of efficacy and safety of MEDI2070 in patients with active, moderate-to-severe Crohn´s disease. | A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects with Moderate to Severe Crohn´s Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy | Crohn´s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MEDI2070 INN or Proposed INN: Not available Other descriptive name: Anti-IL-23 monoclonal antibody | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Germany;Italy | ||
| 1289 | EUCTR2012-002432-93-CZ (EUCTR) | 18/01/2013 | 05/09/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohns disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Russian Federation;Bulgaria | |||
| 1290 | EUCTR2011-002817-12-CZ (EUCTR) | 09/01/2013 | 08/11/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s DiseaseRandomizované, dvojite zaslepené klinické hodnocení aktivní lécby pro navození klinické odpovedi a/nebo remise pri podávání GSK1605786A pacientum se stredne težkou až težkou aktivní Crohnovou chorobou. | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Japan;New Zealand | |||
| 1291 | EUCTR2012-002030-37-BE (EUCTR) | 08/01/2013 | 05/09/2012 | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT | Crohn’s Disease (CD) and Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-00547659 Other descriptive name: Anti-MAdCAM antibody | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 1292 | EUCTR2012-000529-31-NL (EUCTR) | 07/01/2013 | 22/01/2013 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom | ||
| 1293 | NCT01817426 (ClinicalTrials.gov) | January 2013 | 29/8/2012 | Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission | Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission: A Multi-center, Double Blinded, Randomized, Placebo Controlled Study | Crohn Disease | Drug: Infliximab;Other: Placebo | Copenhagen University Hospital at Herlev | NULL | Completed | 18 Years | N/A | All | 115 | Phase 4 | Denmark;Finland;Norway;Sweden |
| 1294 | NCT02501291 (ClinicalTrials.gov) | January 2013 | 20/5/2015 | Thalidomide in Treating Crohn's Disease | Thalidomide in Inducing and Maintaining Remission of Crohn's Disease | Crohn's Disease | Drug: Thalidomide | First Affiliated Hospital, Sun Yat-Sen University | NULL | Completed | 18 Years | 75 Years | Both | 47 | Phase 2 | China |
| 1295 | NCT01880307 (ClinicalTrials.gov) | January 2013 | 7/6/2013 | Infliximab Top-down in Pediatric Crohn | Infliximab Top-down Study in Kids With Crohn's Disease | Crohn's Disease | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolon | Erasmus Medical Center | University of Roma La Sapienza;University Hospital, Brussels | Terminated | 3 Years | 17 Years | Both | 13 | Phase 4 | Italy;Netherlands |
| 1296 | EUCTR2011-000722-30-IT (EUCTR) | 30/12/2012 | 19/12/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-04236921 INN or Proposed INN: PF-04236921 Other descriptive name: IMP will be labeled as PF-04236921 106mg/vial, Clonal SC lyophilized form | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 180 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Australia;Denmark;New Zealand;Sweden | |||
| 1297 | EUCTR2011-002817-12-DK (EUCTR) | 19/12/2012 | 30/11/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden | ||
| 1298 | EUCTR2012-000529-31-DE (EUCTR) | 17/12/2012 | 01/10/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | ||
| 1299 | EUCTR2011-002817-12-HU (EUCTR) | 13/12/2012 | 06/11/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1300 | NCT01696396 (ClinicalTrials.gov) | December 4, 2012 | 27/9/2012 | Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Abrilumab;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 254 | Phase 2 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Netherlands;Switzerland;United Kingdom;Czech Republic |
| 1301 | NCT01752790 (ClinicalTrials.gov) | December 2012 | 12/12/2012 | Efficacy and Safety of Top-down Therapy in Pediatric Crohn's Disease | Efficacy and Safety of Infliximab as First-line Therapy in Pediatric Crohn's Disease: a Randomized, Controlled, Open-label Trial | Pediatric Crohn's Disease | Drug: Top-down;Drug: Step-up | University of Roma La Sapienza | NULL | Withdrawn | 6 Years | 18 Years | Both | 0 | Phase 4 | Italy |
| 1302 | NCT01820247 (ClinicalTrials.gov) | December 2012 | 25/3/2013 | Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission | Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission | Crohn's Disease | Drug: enteral nutrition;Drug: Tripterygium glycosides | Zhu Weiming | NULL | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China |
| 1303 | NCT01757964 (ClinicalTrials.gov) | December 2012 | 22/12/2012 | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CD | Biological: Bacteriotherapy | David Suskind | Seattle Children's Hospital | Completed | 12 Years | 21 Years | All | 13 | Phase 1 | United States |
| 1304 | NCT01735461 (ClinicalTrials.gov) | December 2012 | 22/11/2012 | Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients | Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection | Kidney Calculi;Crohn's Disease | Dietary Supplement: Calcium Carbonate | University of British Columbia | University of Texas Southwestern Medical Center | Recruiting | 19 Years | N/A | All | 40 | N/A | Canada |
| 1305 | NCT01078935 (ClinicalTrials.gov) | December 2012 | 1/3/2010 | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation | The Effect of Probiotics on Bowel Disease | Crohn's Disease;Ulcerative Colitis | Dietary Supplement: probiotics;Dietary Supplement: placebo | The Baruch Padeh Medical Center, Poriya | Ministry of Health, Israel | Not yet recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | NULL |
| 1306 | NCT01349920 (ClinicalTrials.gov) | November 28, 2012 | 5/5/2011 | Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143) | An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD) | Crohn Disease | Drug: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 60 Years | All | 15 | Moldova, Republic of;United Kingdom | |
| 1307 | EUCTR2012-002432-93-ES (EUCTR) | 16/11/2012 | 02/10/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn?s disease | Crohns disease MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | United States;Serbia;Hungary;Czech Republic;Slovakia;Poland;Spain;Bulgaria;Russian Federation | |||
| 1308 | EUCTR2011-001733-16-NL (EUCTR) | 15/11/2012 | 22/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib (CP-690,550) Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1309 | EUCTR2011-001754-28-NL (EUCTR) | 15/11/2012 | 27/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib (CP-690,550) | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1310 | EUCTR2012-000529-31-HU (EUCTR) | 13/11/2012 | 04/10/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 16.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Czech Republic;Hungary;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | ||
| 1311 | EUCTR2011-000722-30-CZ (EUCTR) | 12/11/2012 | 21/03/2012 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1312 | EUCTR2011-003622-27-CZ (EUCTR) | 12/11/2012 | 03/04/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1313 | EUCTR2011-001733-16-CZ (EUCTR) | 12/11/2012 | 22/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1314 | EUCTR2011-001754-28-CZ (EUCTR) | 12/11/2012 | 15/02/2012 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1315 | EUCTR2010-023034-23-CZ (EUCTR) | 12/11/2012 | 26/06/2012 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1316 | EUCTR2012-000529-31-BE (EUCTR) | 09/11/2012 | 19/09/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | ||
| 1317 | EUCTR2012-002432-93-HU (EUCTR) | 08/11/2012 | 25/09/2012 | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy and safety of NNC0114-0006 in subjects with active Crohn’s disease | Crohns disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: 0114-0006B INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 114 | United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Bulgaria | |||
| 1318 | NCT01823029 (ClinicalTrials.gov) | November 2012 | 25/3/2013 | Oxidative Stress and Inflammation Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia | Crohn's Disease | Drug: erythropoietin;Drug: enteral nutrition.;Drug: injection of iron | Jinling Hospital, China | Ministry of Health, China | Completed | 18 Years | 75 Years | Both | 387 | N/A | China | |
| 1319 | EUCTR2012-000529-31-CZ (EUCTR) | 18/10/2012 | 21/09/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | United States;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom | ||
| 1320 | EUCTR2012-000645-13-NL (EUCTR) | 17/10/2012 | 12/07/2012 | Infliximab as first treatment instead of second line treatment in Crohns disease | Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Belgium;Netherlands;Italy | |||
| 1321 | EUCTR2012-000529-31-DK (EUCTR) | 10/10/2012 | 26/09/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Austria;Denmark;Netherlands;Germany;United Kingdom | ||
| 1322 | EUCTR2012-000529-31-AT (EUCTR) | 09/10/2012 | 03/10/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Phase 2 | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | ||
| 1323 | EUCTR2011-004763-72-NL (EUCTR) | 04/10/2012 | 30/05/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Germany;Netherlands;Korea, Republic of | ||
| 1324 | EUCTR2011-006084-22-GB (EUCTR) | 04/10/2012 | 15/08/2012 | Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment | Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab | Royal Liverpool University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 0 | United Kingdom | |||
| 1325 | NCT01562951 (ClinicalTrials.gov) | October 2012 | 13/3/2012 | Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants | cAlprotectin and hsCRP as Markers of a New Diagnostic-therapeutic strAtegy That Assesses muCosal Activity to individuaLize Treatment and Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants | Crohn's Disease;Mucosal Inflammation | Drug: ADALIMUMAB;Drug: Placebo | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Abbott;TFS Trial Form Support | Terminated | 18 Years | 75 Years | Both | 15 | Phase 3 | Belgium;France;Spain |
| 1326 | NCT01823042 (ClinicalTrials.gov) | October 2012 | 25/3/2013 | The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD) | A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD). | Crohn's Disease | Drug: azathioprine+enteral nutrition;Drug: Azathioprine | Jinling Hospital, China | NULL | Recruiting | 18 Years | 75 Years | Both | 100 | N/A | China |
| 1327 | NCT01692808 (ClinicalTrials.gov) | October 2012 | 17/9/2012 | Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease | Bioavailability of Vitamin D in Children and Adolescents With Crohn's Disease. | Crohn's Disease | Drug: Vitamin D3 3000 UI daily;Drug: Vitamin D3 4000 UI daily | St. Justine's Hospital | NULL | Completed | 10 Years | 18 Years | Both | 20 | Phase 2 | Canada |
| 1328 | NCT01596894 (ClinicalTrials.gov) | October 2012 | 12/4/2012 | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease | A Randomized, Single Blinded, Controlled, Multi Center Phase 4 Study for Induction of Remission in Active Pediatric Crohn's Disease, Using 2 Months Antibiotic Course of Azithromycin Combined With Metronidazole vs. Metronidazole Alone. | Crohn's Disease | Drug: Azithromycin + Metronidazole;Drug: Metronidazole | Prof. Arie Levine | NULL | Completed | 5 Years | 17 Years | All | 73 | Phase 4 | Israel |
| 1329 | EUCTR2012-000529-31-GB (EUCTR) | 27/09/2012 | 21/09/2012 | A study to find out more about the effect of AMG 181 in people with moderate to severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 INN or Proposed INN: AMG 181 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 252 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Hungary;Czech Republic;Canada;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom | ||
| 1330 | EUCTR2010-024638-48-BG (EUCTR) | 26/09/2012 | 03/10/2012 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Portugal;United States;Serbia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of | ||
| 1331 | EUCTR2012-002702-51-DK (EUCTR) | 24/09/2012 | 01/08/2012 | Discontinuation of biologic therapy (infliximab) in patients with Crohn’s disease during sustained complete absence of disease activity: A Nordic multi-center, double blinded, randomized, placebo controlled study | Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT | Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Remsima Product Name: Remsima | Department of medical gastroenterology S, Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 1332 | EUCTR2010-023437-30-BG (EUCTR) | 18/09/2012 | 17/07/2012 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA | Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | ||
| 1333 | EUCTR2011-004763-72-GB (EUCTR) | 13/09/2012 | 25/06/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01+ UK-specific Amendment 04 (dated 23-Apr-12) | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Hong Kong;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1334 | EUCTR2011-006064-43-IT (EUCTR) | 13/09/2012 | 05/03/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks. ADMIRE-CD study. - ADIMIRE-CD study | Perianal fistulising Crohn's disease MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 milion cells/ml suspension for injection. Cx601 Product Code: Cx601 INN or Proposed INN: NA Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extractd from adipose tissue (eASCs) | CELLERIX S.A. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy | ||
| 1335 | NCT01632462 (ClinicalTrials.gov) | September 2012 | 25/6/2012 | A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease | A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease | Crohn's Disease | Drug: VSL#3 | Federico II University | NULL | Recruiting | 5 Years | 17 Years | Both | 30 | Phase 4 | Italy |
| 1336 | EUCTR2011-003622-27-DE (EUCTR) | 20/08/2012 | 30/03/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE - | Crohn's Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Netherlands Antilles;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1337 | EUCTR2011-000854-44-LV (EUCTR) | 10/08/2012 | 19/06/2012 | A clinical study for treatment of Crohns Disease with the new drug substance TRK-170. The study consists of two parts and are conducted at servral hopsitals in Europe. Patients in the study may receive placebo (drug with no effect) but either the doctor or the patient will know during the study. | A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn’s Disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Czech Republic;Hungary;Poland;Bulgaria;Norway;Latvia;Sweden | |||
| 1338 | EUCTR2011-005846-36-DK (EUCTR) | 31/07/2012 | 31/07/2012 | Bloodflow measurements in stenotic inflammatory bowel disease. | Safe evaluation of obstructive crohns disease using bloodflow Time-intensity curves and Elastography correlated to Neutrocytes and collagen counts and biomechanical properties Obtained in Stenotic Intestine after Surgery (STENOSIS) - STENOSIS | Crohns Disease undergoing elective surgery for intestinal stenosis. MedDRA version: 14.1;Level: PT;Classification code 10058829;Term: Elective surgery;System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;Classification code 10022699;Term: Intestinal stenosis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: SonoVue INN or Proposed INN: sulphur hexafluoride Other descriptive name: SULFUR HEXAFLUORIDE | Gastroenterology MIDT | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Denmark | ||
| 1339 | EUCTR2011-005886-19-DK (EUCTR) | 31/07/2012 | 31/07/2012 | Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) | Correlation between intestinal blOod flow assessed by magNetic resonance imaging and ulTRASound Techniques (CONTRAST) - CONTRAST | Crohns Disease with active disease MedDRA version: 14.1;Level: PT;Classification code 10059696;Term: Scan with contrast;System Organ Class: 10022891 - Investigations MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10028049;Term: MRI;Classification code 10045434;Term: Ultrasound scan;System Organ Class: 10022891 - Investigations;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: SonoVue INN or Proposed INN: sulphur hexafluoride Other descriptive name: SULFUR HEXAFLUORIDE | Gastroenterology MIDT | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Denmark | ||
| 1340 | EUCTR2011-002517-11-BG (EUCTR) | 18/07/2012 | 27/06/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | France;Serbia;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany | ||
| 1341 | NCT01570348 (ClinicalTrials.gov) | July 17, 2012 | 2/4/2012 | Crohn's Allogeneic Transplant Study | Allogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 Study | Crohn Disease | Procedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body Irradiation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI);National Institutes of Health (NIH) | Terminated | 18 Years | 60 Years | All | 2 | Phase 2 | United States |
| 1342 | EUCTR2011-004763-72-IT (EUCTR) | 16/07/2012 | 03/09/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) | Crohn’s Disease MedDRA version: 15.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 Other descriptive name: anti-IL-6 mAb | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;India;Czech Republic;Hungary;European Union;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1343 | EUCTR2011-004763-72-CZ (EUCTR) | 11/07/2012 | 21/05/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of;United States | ||
| 1344 | EUCTR2011-003622-27-BG (EUCTR) | 11/07/2012 | 19/05/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1345 | EUCTR2010-022382-10-AT (EUCTR) | 10/07/2012 | 24/04/2012 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden | |||
| 1346 | EUCTR2011-004763-72-DE (EUCTR) | 04/07/2012 | 27/04/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12);Pharmacogenetics Blood Sample Amendment 01 | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1347 | EUCTR2011-006064-43-NL (EUCTR) | 03/07/2012 | 05/07/2012 | Study to assess efficacy and safety of stem cells derived from allogeneic adipose tissue for the treatment of perianal fistulas in patients with Crohn's disease. | A phase III, randomised, double blind, parallel group, placebo controlled, multicentre study to assess efficacy and safety of expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of perianal fistulising Crohn’s disease over a period of 24 weeks and an extended follow-up period up to 52 weeks. ADMIRE-CD study. - ADMIRE-CD study | Perianal fistulising Crohn´s disease MedDRA version: 16.0;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Allogenic eASCs 5 million/ml suspension for injection. Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesemchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A. Unipersonal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Germany;Netherlands;Italy | ||
| 1348 | NCT01576471 (ClinicalTrials.gov) | July 2012 | 10/4/2012 | Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo | A Phase II Study to Evaluate the Efficacy and Safety of 12 Weeks of Treatment With Oral CNDO 201 Trichuris Suis Ova Suspension (TSO) as Compared to Placebo, Followed by a 12 Week Open-label Treatment Period in Patients With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Biological: Trichuris suis ova (TSO);Biological: Placebo | Coronado Biosciences, Inc. | NULL | Completed | 18 Years | 65 Years | All | 250 | Phase 2 | United States |
| 1349 | NCT01659762 (ClinicalTrials.gov) | July 2012 | 6/8/2012 | A Phase I Study Evaluating Autologous Bone Marrow Derived Mesenchymal Stromal for Crohn's Disease. | A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow Derived Mesenchymal Stromal (MSC) Cells in Adults With Moderate to Severe Crohn's Disease. | Crohn's Disease | Biological: autologous mesenchymal stromal cell | Emory University | Atlanta Clinical and Translational Science Institute;Atlanta Clinical and Translational Science Institute | Completed | 18 Years | 65 Years | Both | 16 | Phase 1 | United States |
| 1350 | NCT01629628 (ClinicalTrials.gov) | July 2012 | 19/6/2012 | Adalimumab for the Management of Post-operative Crohn's Disease (CD) | An Investigator Initiated Prospective, Single Center, Randomized, Open Label Study to Assess the Efficacy of Adalimumab for the Maintenance of Remission in Post-operative CD Patients | Crohn Disease | Drug: Adalimumab;Drug: 6 Mercaptopurine | Tel-Aviv Sourasky Medical Center | Abbott | Not yet recruiting | 18 Years | 70 Years | Both | 100 | Phase 3 | Israel |
| 1351 | EUCTR2011-004763-72-HU (EUCTR) | 26/06/2012 | 26/04/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1352 | NCT00692939 (ClinicalTrials.gov) | June 26, 2012 | 3/6/2008 | Autologous Stem Cell Transplantation for Crohn's Disease | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Pediatric and Adult Patients With Severe Crohn's Disease | Crohn's Disease | Biological: autologous CD34-selected peripheral blood stem cells transplant;Drug: Alemtuzumab;Drug: ATG;Drug: Melphalan;Drug: Thiotepa;Drug: Rituximab;Drug: Cyclophosphamide;Drug: G-CSF;Drug: Mesna | Paul Szabolcs | NULL | Recruiting | 10 Years | 60 Years | All | 20 | Phase 1/Phase 2 | United States |
| 1353 | EUCTR2011-003038-14-NL (EUCTR) | 21/06/2012 | 31/05/2012 | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX | Luminal active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: INFLIXIMAB Product Name: INFLIXIMAB INN or Proposed INN: INFLIXIMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Netherlands | |||
| 1354 | EUCTR2010-022382-10-ES (EUCTR) | 20/06/2012 | 11/05/2012 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn's Disease | Subjects with Moderately-to-Severely Active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;South Africa;Norway;Netherlands;Germany;New Zealand;Japan;Sweden;Korea, Republic of | ||
| 1355 | EUCTR2012-000729-28-ES (EUCTR) | 13/06/2012 | 17/04/2012 | Imaging study in patients with Crohn`s Disease | MULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY | Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease MedDRA version: 14.1;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | Product Name: / Product Code: / INN or Proposed INN: ÁCIDO GADOBÉNICO Other descriptive name: NA | Genentech, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Belgium;France;Spain;United States | |||
| 1356 | EUCTR2011-004820-37-ES (EUCTR) | 13/06/2012 | 15/02/2012 | Experimental study in humans to evaluate the efficacy and safety of bloodproducts rich in proteins for the treatment of anal fistulas in Crohn'spatients | Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients | Perianal fistulas in Crohn's Disease Patients MedDRA version: 14.1;Level: LLT;Classification code 10068659;Term: Perianal fistula;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Other descriptive name: HUMAN PLASMA FOR FRACTIONATION | Fundación FISEVI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Spain | |||
| 1357 | EUCTR2009-017998-37-BE (EUCTR) | 08/06/2012 | 11/04/2012 | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy. | Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease. MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia 200 mg solution for injection Product Name: Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL | Ghent University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium | ||
| 1358 | EUCTR2011-003622-27-SE (EUCTR) | 07/06/2012 | 09/02/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden | |||
| 1359 | EUCTR2010-023437-30-PL (EUCTR) | 06/06/2012 | 08/05/2012 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA | Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1360 | EUCTR2011-006127-38-ES (EUCTR) | 05/06/2012 | 15/02/2012 | Experimental study in humans to evaluate the efficacy and safety of blood products rich in proteins for the treatment of anal fistulas in Crohn's patients without subsidiary drug treatment. | Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot in processed with PRGF-system technology, in the treatment of anal fistulas in Crohn's patients with no concomitant therapy with second-line drugs. | Perianal fistulas in Crohn's Disease Patients MedDRA version: 14.1;Level: PT;Classification code 10002156;Term: Anal fistula;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Product Name: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) INN or Proposed INN: Plasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI) Other descriptive name: HUMAN PLASMA FOR FRACTIONATION | Fundación FISEVI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Spain | |||
| 1361 | EUCTR2011-003622-27-GR (EUCTR) | 05/06/2012 | 24/05/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden | ||
| 1362 | EUCTR2011-001754-28-DE (EUCTR) | 05/06/2012 | 17/10/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1363 | EUCTR2010-024638-48-PL (EUCTR) | 04/06/2012 | 09/05/2012 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017, United States | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Serbia;Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 1364 | EUCTR2011-000854-44-BG (EUCTR) | 01/06/2012 | 07/05/2012 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hospitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 INN or Proposed INN: Not available Product Name: TRK-170 Product Code: TRK-170 INN or Proposed INN: Not available | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden | |||
| 1365 | NCT01181765 (ClinicalTrials.gov) | June 2012 | 12/8/2010 | The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy | The Efficacy of Open Label Infliximab for the Induction and Maintenance of Mucosal Healing in Small Bowel Crohn's Disease Assessed Through Wireless Camera Endoscopy (the ICE Study) | Crohn's Disease | Biological: Infliximab 5 mg/kg body weight infused over 2 hours | Janssen Inc. | NULL | Completed | 18 Years | N/A | Both | 1 | Phase 4 | Canada |
| 1366 | NCT02445547 (ClinicalTrials.gov) | June 2012 | 13/5/2015 | Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease | Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease: A Randomized Controlled Clinical Trial | Crohn Disease | Other: UC-MSCs by peripheral intravenous infusion;Drug: received hormone maintenance therapy | Fuzhou General Hospital | Shaanxi Provincial People's Hospital | Completed | 18 Years | 70 Years | All | 82 | Phase 1/Phase 2 | China |
| 1367 | NCT01624376 (ClinicalTrials.gov) | June 2012 | 14/6/2012 | Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105. | Fistulizing Crohn's Disease | Drug: DLX105;Drug: Placebo | Delenex Therapeutics AG | NULL | Completed | 18 Years | 65 Years | Both | 18 | Phase 2 | Switzerland |
| 1368 | NCT01564823 (ClinicalTrials.gov) | June 2012 | 31/1/2012 | Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease | Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease | Crohn´s Disease | Drug: Metronidazole;Drug: Azathioprine;Drug: Adalimumab | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Effice Servicios Para la Investigacion S.L. | Completed | 18 Years | N/A | Both | 86 | Phase 3 | Spain |
| 1369 | NCT01442025 (ClinicalTrials.gov) | June 2012 | 20/9/2011 | Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease | A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease | Crohn's Disease | Drug: Infliximab | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Completed | 18 Years | N/A | Both | 121 | Phase 4 | France |
| 1370 | NCT01545050 (ClinicalTrials.gov) | June 2012 | 1/3/2012 | Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-945429 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Placebo matching with BMS-945429;Biological: BMS-945429 | CSL Behring | NULL | Terminated | 18 Years | N/A | All | 72 | Phase 2 | United States;Austria;Canada;Czechia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Switzerland;Taiwan;United Kingdom;Australia;Brazil;Czech Republic;Russian Federation;Singapore |
| 1371 | NCT01635621 (ClinicalTrials.gov) | June 2012 | 3/7/2012 | A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's Disease | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Olokizumab (OKZ);Drug: Placebo | UCB BIOSCIENCES GmbH | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | Bulgaria;Czech Republic;Germany;Hungary;Poland |
| 1372 | EUCTR2011-001754-28-BG (EUCTR) | 29/05/2012 | 07/05/2012 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 18.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1373 | EUCTR2011-001733-16-BG (EUCTR) | 29/05/2012 | 30/03/2012 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1374 | EUCTR2011-004763-72-AT (EUCTR) | 25/05/2012 | 27/04/2012 | Phase IIB Dose Ranging Study of BMS-945429 in subjects with moderate to severe Crohn’s Disease | A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12)+ Pharmacogenetics Blood Sample Amendment 01 | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: Anti-Interleukin-6 Monoclonal Antibody Other descriptive name: anti-IL-6 mAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 2 | United States;Hong Kong;Taiwan;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Singapore;Australia;Netherlands;Germany;Korea, Republic of | ||
| 1375 | EUCTR2010-022382-10-SK (EUCTR) | 22/05/2012 | 12/04/2012 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Slovakia;Spain;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;South Africa;Netherlands;Germany;Norway;Japan;New Zealand;Korea, Republic of;Sweden | |||
| 1376 | EUCTR2010-022384-35-SK (EUCTR) | 16/05/2012 | 13/04/2012 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1377 | EUCTR2011-003622-27-HU (EUCTR) | 10/05/2012 | 21/03/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE | Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Ukraine;United States;Greece;Spain;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1378 | NCT01387594 (ClinicalTrials.gov) | May 2012 | 30/6/2011 | Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs | A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA) | Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis | Procedure: lumbar puncture;Drug: lumbar puncture | Shire | NULL | Completed | 18 Years | 75 Years | All | 49 | Phase 1 | Austria;Belgium;France;Germany;Netherlands |
| 1379 | EUCTR2011-002517-11-CZ (EUCTR) | 23/04/2012 | 25/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Hungary;Czech Republic;Germany | |||
| 1380 | EUCTR2011-002817-12-SK (EUCTR) | 19/04/2012 | 13/04/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Germany;France;Hong Kong;Austria;Sweden;South Africa;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Hungary;Switzerland;Netherlands;Chile;Norway;Italy;Israel;United Kingdom;Russian Federation;Slovakia;Ukraine;Taiwan;Denmark;Argentina;Estonia;China;Spain;Japan | |||
| 1381 | EUCTR2011-003622-27-ES (EUCTR) | 17/04/2012 | 16/02/2012 | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASE | A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN?S DISEASE | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Sweden | ||
| 1382 | EUCTR2010-022758-18-BE (EUCTR) | 16/04/2012 | 07/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1383 | EUCTR2010-022760-12-BE (EUCTR) | 16/04/2012 | 07/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1384 | EUCTR2011-000722-30-GB (EUCTR) | 12/04/2012 | 06/05/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1385 | EUCTR2010-023589-39-DE (EUCTR) | 10/04/2012 | 16/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 1386 | EUCTR2011-001733-16-DE (EUCTR) | 10/04/2012 | 18/10/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tofacitinib Product Code: CP-690,550-10 INN or Proposed INN: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Czech Republic;Hungary;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1387 | EUCTR2011-000854-44-CZ (EUCTR) | 04/04/2012 | 12/01/2012 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden | |||
| 1388 | EUCTR2010-022760-12-NL (EUCTR) | 04/04/2012 | 13/07/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Phase 3 | Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1389 | EUCTR2011-001754-28-GR (EUCTR) | 02/04/2012 | 16/02/2012 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden;Croatia;Canada;Czech Republic;Hungary;France;India;Israel;Austria;Ukraine;Spain;Greece;Slovakia;United States | |||
| 1390 | NCT01470599 (ClinicalTrials.gov) | April 2012 | 27/10/2011 | A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease | A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease | Crohn's Disease | Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | 76 Years | All | 150 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;Czech Republic |
| 1391 | NCT01369667 (ClinicalTrials.gov) | April 2012 | 7/6/2011 | Vitamin D Supplementation in Adult Crohn's Disease | Vitamin D and Immunomodulation: Effects in Crohn's Disease | Crohn's Disease | Dietary Supplement: Vitamin D3;Other: Placebo | University of Dublin, Trinity College | Queen Mary University of London | Completed | 18 Years | 75 Years | Both | 117 | Phase 4 | Ireland |
| 1392 | NCT01556672 (ClinicalTrials.gov) | April 2012 | 15/3/2012 | Adalimumab-psoriasis and Small Bowel Lesions | Open-label Study on Small Bowel Lesions Suggestive of Crohn's Disease in Patients With Moderate to Severe Plaque Psoriasis Treated With Adalimumab | Plaque Psoriasis;Crohn's Disease | Drug: Adalimumab;Device: Capsule endoscopy | Innovaderm Research Inc. | Abbott;Abbott | Completed | 18 Years | 80 Years | Both | 100 | Phase 4 | Canada |
| 1393 | NCT01877577 (ClinicalTrials.gov) | April 2012 | 11/6/2013 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | NULL | Completed | 18 Years | N/A | Both | 30 | N/A | United States |
| 1394 | EUCTR2011-003038-14-BE (EUCTR) | 30/03/2012 | 03/01/2012 | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE | A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX | Luminal active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: INFLIXIMAB Product Name: INFLIXIMAB INN or Proposed INN: INFLIXIMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Belgium;Netherlands | |||
| 1395 | EUCTR2010-022384-35-PT (EUCTR) | 29/03/2012 | 18/01/2012 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1396 | EUCTR2011-002817-12-PT (EUCTR) | 29/03/2012 | 18/01/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1397 | EUCTR2010-022383-12-PT (EUCTR) | 29/03/2012 | 18/01/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1398 | EUCTR2010-022382-10-IT (EUCTR) | 28/03/2012 | 02/03/2012 | A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to-Severely Active Crohn's Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigatethe Efficacy and Safety of GSK1605786A in the Treatment of Subjectswith Moderately-to Severely Active Crohn's Disease | Subjects with Moderately-to-Severely Active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: NA Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;South Africa;Norway;Germany;Netherlands;Japan;New Zealand;Sweden | |||
| 1399 | EUCTR2010-022384-35-IT (EUCTR) | 28/03/2012 | 02/03/2012 | A 25 month study of a potential new medicine (GSK1605786A) for thetreatment of Crohn's disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A inSubjects with Crohn's Disease - Open label extension study | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: NA Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand;Japan;Sweden | |||
| 1400 | EUCTR2010-022383-12-IT (EUCTR) | 28/03/2012 | 02/03/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study toInvestigate the Efficacy and Safety of GSK1605786A in the Maintenanceof Remission in Subjects with Crohn's Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: NA Other descriptive name: NA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Estonia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Japan;Sweden | |||
| 1401 | EUCTR2010-022384-35-ES (EUCTR) | 27/03/2012 | 11/01/2012 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn's disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn's Disease - Open label extension study | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1402 | EUCTR2010-022383-12-ES (EUCTR) | 27/03/2012 | 11/01/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn's Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1403 | EUCTR2011-002817-12-ES (EUCTR) | 27/03/2012 | 11/01/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn's Disease | Moderately-to-Severely Active Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1404 | EUCTR2011-002517-11-HU (EUCTR) | 26/03/2012 | 09/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany | |||
| 1405 | EUCTR2011-002981-19-PL (EUCTR) | 21/03/2012 | 12/01/2012 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's Disease.Revised Protocol 043 incorporating Protocol Amendment 05Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.1;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;France;Hungary;Belgium;Poland;South Africa | ||
| 1406 | EUCTR2010-024638-48-BE (EUCTR) | 19/03/2012 | 25/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 1407 | EUCTR2010-022384-35-AT (EUCTR) | 13/03/2012 | 27/12/2011 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;New Zealand;Sweden | |||
| 1408 | EUCTR2011-000722-30-BE (EUCTR) | 12/03/2012 | 05/09/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 160 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1409 | EUCTR2010-023034-23-BE (EUCTR) | 12/03/2012 | 05/09/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1410 | EUCTR2011-005966-39-BE (EUCTR) | 08/03/2012 | 12/12/2011 | Therapeutic effect of mesenchymal cells in patients suffering from a disease characterized by a severe inflammation and/or in whom the immune system attacks their own tissues. | Mesenchymal stem cell therapy for the treatment of severe or refractory inflammatory and/or autoimmune disorders. | Crohn's disease MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.0;Level: PT;Classification code 10064147;Term: Gastrointestinal inflammation;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mesenchymal stem cells Product Code: MSC | CHU-ULg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Belgium | |||
| 1411 | EUCTR2010-022383-12-SK (EUCTR) | 07/03/2012 | 12/04/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1412 | EUCTR2011-002981-19-HU (EUCTR) | 06/03/2012 | 27/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | France;United States;Hungary;Belgium;Poland;South Africa | ||
| 1413 | EUCTR2010-022384-35-EE (EUCTR) | 01/03/2012 | 06/02/2012 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | ||
| 1414 | EUCTR2010-022383-12-EE (EUCTR) | 01/03/2012 | 06/02/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1415 | EUCTR2011-002817-12-EE (EUCTR) | 01/03/2012 | 06/02/2012 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | Greece;United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;New Zealand | |||
| 1416 | NCT01647412 (ClinicalTrials.gov) | March 2012 | 19/7/2012 | Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease | Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial | Crohn's Disease | Drug: Growth Hormone;Dietary Supplement: Nutraceutical Combination;Other: Exclusion Diet;Other: Placebo Growth Hormone | Columbia University | NULL | Withdrawn | 10 Years | 17 Years | Both | 0 | Phase 2 | United States |
| 1417 | NCT01957423 (ClinicalTrials.gov) | March 2012 | 24/9/2013 | Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients. | Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy. | Crohn's Disease | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | N/A | N/A | Both | 41 | N/A | Brazil |
| 1418 | NCT02450513 (ClinicalTrials.gov) | March 2012 | 12/5/2015 | Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study | Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study | Crohn's Disease | Drug: Adalimumab | Universitaire Ziekenhuizen Leuven | NULL | Recruiting | 18 Years | 65 Years | Both | 30 | N/A | Belgium |
| 1419 | NCT01580670 (ClinicalTrials.gov) | March 2012 | 3/4/2012 | Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease | Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Crohn's Disease | Pediatric Crohn's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 6 Years | 17 Years | All | 14 | Phase 3 | Japan |
| 1420 | NCT01393899 (ClinicalTrials.gov) | March 2012 | 12/7/2011 | The Safety And Efficacy Of Maintenance Therapy With CP-690,550 | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 180 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;Croatia;India |
| 1421 | EUCTR2011-002517-11-DE (EUCTR) | 22/02/2012 | 02/11/2011 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany | |||
| 1422 | EUCTR2010-024638-48-DE (EUCTR) | 22/02/2012 | 30/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 1423 | EUCTR2010-022383-12-PL (EUCTR) | 15/02/2012 | 11/01/2012 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1424 | EUCTR2010-022384-35-PL (EUCTR) | 15/02/2012 | 11/01/2012 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1425 | EUCTR2011-002981-19-BE (EUCTR) | 14/02/2012 | 14/12/2011 | Induction and Maintenance Study of BMS-936557 in Patients with Moderate to Severely Active Crohn’s Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Crohn's DiseaseRevised Protocol 03 incorporating Protocol Amendment 04;Pharmacogenetics Blood Sample Amendment 01 | CROHN’S DISEASE MedDRA version: 16.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 MedDRA version: 16.0;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Human anti-IP10 monoclonal antibody Product Code: BMS-936557 INN or Proposed INN: Human anti-IP10 monoclonal antibody Other descriptive name: MDX-1100 | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | France;United States;Hungary;Poland;Belgium;South Africa | ||
| 1426 | EUCTR2011-001754-28-ES (EUCTR) | 02/02/2012 | 07/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn?s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE | Crohn's disease MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1427 | NCT01514240 (ClinicalTrials.gov) | February 2012 | 10/1/2012 | Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase III Study to Assess Efficacy and Safety of D9421-C 9 mg Versus Mesalazine 3 g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Drug: D9421-C capsule 3 mg;Drug: Mesalazine tablets | AstraZeneca | NULL | Completed | 15 Years | 130 Years | All | 123 | Phase 3 | Japan |
| 1428 | EUCTR2010-024638-48-NO (EUCTR) | 31/01/2012 | 01/06/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Portugal;Serbia;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Norway;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 1429 | EUCTR2011-001754-28-AT (EUCTR) | 26/01/2012 | 21/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1430 | EUCTR2011-002817-12-AT (EUCTR) | 26/01/2012 | 28/12/2011 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1431 | EUCTR2010-022383-12-AT (EUCTR) | 26/01/2012 | 29/12/2011 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;Switzerland;Denmark;Australia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 1432 | EUCTR2011-001733-16-AT (EUCTR) | 26/01/2012 | 21/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1433 | EUCTR2011-001733-16-HU (EUCTR) | 24/01/2012 | 14/11/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 16.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Norway;Germany;Japan;Korea, Republic of;Sweden | |||
| 1434 | EUCTR2011-005678-47-IT (EUCTR) | 19/01/2012 | 21/12/2011 | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. | A phase II multi-center, randomized, double-blind, controlled vs placebo, long-term extension study to evaluate the safety and tolerability of 40 mg GED-0301for the maintainance of Crohn’s disease in remission. - IGON 2 | CROHN'S DISEASE IN REMISSION PHASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 1435 | EUCTR2010-020137-10-HU (EUCTR) | 12/01/2012 | 22/11/2011 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Sweden | ||
| 1436 | EUCTR2011-003966-34-ES (EUCTR) | 10/01/2012 | 13/10/2011 | Biomarkers in diagnosis & treatment of patients with Crohn?s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn?s disease treated with immunosuppressants - not applicable | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Spain | |||
| 1437 | EUCTR2011-001754-28-HU (EUCTR) | 10/01/2012 | 17/11/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 17.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib Product Code: CP-690,550-10 Other descriptive name: Tofacitinib | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Greece;Spain;Ukraine;Austria;Israel;France;Hungary;Czech Republic;Canada;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Japan;Sweden;Korea, Republic of | |||
| 1438 | EUCTR2010-022383-12-GR (EUCTR) | 09/01/2012 | 14/12/2011 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Estonia;Hong Kong;Taiwan;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1439 | EUCTR2011-002817-12-GR (EUCTR) | 09/01/2012 | 14/12/2011 | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission with GSK1605786A in Subjects with Moderately-to-Severely Active Crohn’s Disease | Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 900 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1440 | EUCTR2010-022384-35-GR (EUCTR) | 09/01/2012 | 27/12/2011 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Estonia;Taiwan;Hong Kong;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1441 | EUCTR2011-001733-16-GR (EUCTR) | 09/01/2012 | 14/12/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Croatia;Romania;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1442 | EUCTR2011-001733-16-ES (EUCTR) | 23/12/2011 | 28/10/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn?s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE | Crohn's disease MedDRA version: 14.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1443 | EUCTR2010-022759-42-IS (EUCTR) | 22/12/2011 | 29/10/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1444 | EUCTR2011-000722-30-HU (EUCTR) | 14/12/2011 | 21/10/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1445 | EUCTR2008-005237-30-SE (EUCTR) | 14/12/2011 | 16/08/2011 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP | Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Italy;United States;Sweden | |||
| 1446 | EUCTR2010-022760-12-BG (EUCTR) | 14/12/2011 | 11/11/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Phase 3 | Brazil;Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1447 | EUCTR2010-022382-10-HU (EUCTR) | 14/12/2011 | 11/10/2011 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Japan;Sweden | |||
| 1448 | EUCTR2010-022384-35-HU (EUCTR) | 14/12/2011 | 11/10/2011 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | |||
| 1449 | EUCTR2011-001754-28-SE (EUCTR) | 14/12/2011 | 19/10/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for maintenance therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 108 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Australia;South Africa;Croatia;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1450 | EUCTR2010-022383-12-HU (EUCTR) | 14/12/2011 | 11/10/2011 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | |||
| 1451 | EUCTR2011-003966-34-BE (EUCTR) | 06/12/2011 | 11/10/2011 | Biomarkers in diagnosis & treatment of patients with Crohn’s disease treated with immunosuppressants | The ADACAL Study: cAlprotectin and hsCRP as markers of a new Diagnostic-therapeutic strAtegy that assesses muCosal Activity to individuaLize treatment and improve the prognosis of patients with Crohn’s disease treated with immunosuppressants | Crohn's disease (CD) is an inflammatory disease of the intestines that primarily causes abdominal pain, diarrhea, vomiting, or weight loss.;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Spain;Belgium | ||
| 1452 | EUCTR2010-022759-42-BG (EUCTR) | 02/12/2011 | 11/11/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 612 | Phase 3 | Korea, Republic of;New Zealand;Japan;Germany;Netherlands;Iceland;South Africa;Bulgaria;Australia;Croatia;Brazil;Canada;European Union;Hungary;United Kingdom;Italy;Russian Federation;Israel;Spain;United States | ||
| 1453 | EUCTR2011-003743-22-IT (EUCTR) | 01/12/2011 | 08/03/2012 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entocort INN or Proposed INN: BUDESONIDE | ASTRAZENECA | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Canada;Germany;Italy | ||
| 1454 | EUCTR2010-023437-30-NO (EUCTR) | 01/12/2011 | 01/06/2011 | Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Serbia;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Norway;Germany;Netherlands;Sweden | ||
| 1455 | EUCTR2010-022759-42-NL (EUCTR) | 01/12/2011 | 13/07/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 612 | Phase 3 | United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Germany;Netherlands;Japan;New Zealand;Korea, Republic of | ||
| 1456 | NCT01792388 (ClinicalTrials.gov) | December 2011 | 19/12/2012 | Vitd and Barrier Function in IBD | Vitamin D and Its Effects on Inflammation and Intestinal Permeability in Crohn's Disease in Remission | Crohn's Disease | Dietary Supplement: Vitamin D;Dietary Supplement: Soya Bean oil | University of Dublin, Trinity College | University of Calgary;Queen Mary University of London | Completed | 18 Years | 70 Years | Both | 30 | Phase 4 | Ireland |
| 1457 | NCT01505855 (ClinicalTrials.gov) | December 2011 | 2/1/2012 | Efficacy Study of Pneumococcal Vaccination in Crohn's Disease | Serological Response to Pneumococcal Vaccination in Crohn's Disease: A Prospective Multicenter Study | Crohn's Disease | Drug: 23-valent polysaccharide pneumococcal vaccine | Kyunghee University Medical Center | Wonju Severance Christian Hospital;Seoul National University Hospital;Asan Medical Center;Soonchunhyang University Hospital;Ewha Womans University;Kosin University Gospel Hospital;Chung-Ang University Hospital;Inje University;The Catholic University of Korea;Keimyung University Dongsan Medical Center;Korea University;Wonkwang University;Severance Hospital;Konkuk University Hospital | Completed | 18 Years | N/A | Both | 197 | Phase 4 | Korea, Republic of |
| 1458 | NCT01453946 (ClinicalTrials.gov) | December 2011 | 14/10/2011 | Safety and Maintenance Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Padagis LLC | NULL | Completed | 5 Years | 17 Years | All | 55 | Phase 3 | United States;Canada;Germany;Italy;Poland |
| 1459 | NCT01438151 (ClinicalTrials.gov) | December 2011 | 20/9/2011 | Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease | Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease | Crohn's Disease | Drug: Remicade | Shradha Agarwal | Prometheus Laboratories | Terminated | 7 Years | N/A | All | 11 | N/A | United States |
| 1460 | NCT01466374 (ClinicalTrials.gov) | December 2011 | 3/11/2011 | Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease | A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: BMS-936557 (Anti-IP-10 Antibody) | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | Both | 121 | Phase 2 | United States;Belgium;France;Hungary;Israel;Poland;Puerto Rico;South Africa |
| 1461 | NCT01496053 (ClinicalTrials.gov) | December 2011 | 15/12/2011 | Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study | Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract | Oslo University Hospital | ImmunoPharma AS | Completed | 18 Years | 60 Years | All | 100 | Phase 2/Phase 3 | Norway |
| 1462 | NCT01991314 (ClinicalTrials.gov) | December 2011 | 18/11/2013 | Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate | Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue | Ulcerative Colitis;Crohn's Disease | Drug: Ferrous sulphate | Queen Mary University of London | NULL | Completed | 13 Years | 80 Years | All | 90 | Phase 4 | United Kingdom |
| 1463 | EUCTR2010-023034-23-DE (EUCTR) | 21/11/2011 | 14/07/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1464 | EUCTR2011-001733-16-SE (EUCTR) | 17/11/2011 | 19/10/2011 | A randomized, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the safety and efficacy of CP-690,550 for induction therapy in subjects with moderate to severe Crohn’s disease | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 FOR INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE | Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: CP-690,550-10 | Pfizer Inc.235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;India;France;Hungary;Czech Republic;Canada;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;Germany;Norway;Japan;Korea, Republic of;Sweden | |||
| 1465 | EUCTR2010-023437-30-DE (EUCTR) | 16/11/2011 | 26/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA | Crohn's Disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of | |||
| 1466 | EUCTR2010-024638-48-NL (EUCTR) | 11/11/2011 | 08/06/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Canada;Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 1467 | EUCTR2010-023437-30-NL (EUCTR) | 11/11/2011 | 08/06/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden | |||
| 1468 | NCT01536418 (ClinicalTrials.gov) | November 11, 2011 | 16/2/2012 | An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease | A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: GSK1605786A | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 255 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;China;Czech Republic;Ireland;South Africa |
| 1469 | EUCTR2011-000854-44-PL (EUCTR) | 09/11/2011 | 12/08/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 510 | Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden | |||
| 1470 | EUCTR2011-000722-30-IE (EUCTR) | 02/11/2011 | 13/05/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1471 | NCT01434693 (ClinicalTrials.gov) | November 2011 | 13/9/2011 | Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease | A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease | Crohn's Disease | Biological: Trichuris suis ova;Other: Placebo | Coronado Biosciences, Inc. | NULL | Completed | 18 Years | 55 Years | All | 36 | Phase 1 | United States |
| 1472 | NCT01540942 (ClinicalTrials.gov) | November 2011 | 23/2/2012 | Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | A Randomized, Controlled, Open-label Study to Investigate the Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease | Crohn's Disease | Dietary Supplement: nutrition treat;Other: surgery | Jinling Hospital, China | NULL | Completed | 18 Years | 75 Years | Both | 91 | N/A | China |
| 1473 | NCT01218360 (ClinicalTrials.gov) | November 2011 | 7/10/2010 | Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484) | Observational Study on Disease Severity, Evaluation Tools and the Long Term Impact of Each Treatment Strategy in the Daily Clinical Practice in Patients With Moderate to Severe Active Crohn's Disease (Protocol P06484) | Crohn Disease | Drug: Physician standard-of-care | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | Both | 71 | N/A | Greece |
| 1474 | NCT01442363 (ClinicalTrials.gov) | November 2011 | 26/9/2011 | A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease | Perianal Crohn's Disease | Drug: BLI-1300 low dose;Drug: BLI-1300 high dose;Drug: placebo | Braintree Laboratories | NULL | Terminated | 18 Years | N/A | Both | 8 | Phase 2 | United States | |
| 1475 | NCT01444092 (ClinicalTrials.gov) | November 2011 | 28/9/2011 | Safety Study of Entocort for Children With Crohn's Disease | A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease | Drug: Entocort | Padagis LLC | NULL | Completed | 5 Years | 17 Years | All | 123 | Phase 3 | United States;Canada;Germany;Italy;Poland |
| 1476 | EUCTR2011-000722-30-DK (EUCTR) | 25/10/2011 | 17/10/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden | ||
| 1477 | EUCTR2011-000722-30-GR (EUCTR) | 24/10/2011 | 19/08/2011 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 | A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II) - ANDANTE II | Crohn’s disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1478 | EUCTR2010-022758-18-GB (EUCTR) | 21/10/2011 | 02/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1479 | EUCTR2010-022759-42-GB (EUCTR) | 21/10/2011 | 02/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 612 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 1480 | EUCTR2010-022760-12-GB (EUCTR) | 21/10/2011 | 02/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;New Zealand;Japan | ||
| 1481 | EUCTR2010-023034-23-IT (EUCTR) | 21/10/2011 | 29/12/2011 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS(ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-04236921 INN or Proposed INN: PF-04236921 Other descriptive name: IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''. | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Greece;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1482 | EUCTR2010-022758-18-IE (EUCTR) | 17/10/2011 | 08/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1483 | EUCTR2010-022760-12-IE (EUCTR) | 17/10/2011 | 08/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Japan;New Zealand;Germany;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands | ||
| 1484 | EUCTR2010-022760-12-FR (EUCTR) | 13/10/2011 | 23/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand | ||
| 1485 | NCT01433432 (ClinicalTrials.gov) | October 2011 | 12/9/2011 | Open Label Extension Study to Protocol C2/13/DR-6MP-02 | Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study | Crohn's Disease | Drug: 80 mg DR-6MP | Teva GTC | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2 | Israel |
| 1486 | NCT01393626 (ClinicalTrials.gov) | October 2011 | 11/7/2011 | A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: CP-690,550 | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 280 | Phase 2 | United States;Australia;Austria;Bulgaria;Canada;Croatia;Czech Republic;France;Germany;Greece;Hungary;Israel;Japan;Korea, Republic of;Netherlands;South Africa;Spain;Ukraine;India;Romania;Sweden |
| 1487 | EUCTR2010-024638-48-SK (EUCTR) | 29/09/2011 | 11/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 1488 | EUCTR2010-023437-30-SK (EUCTR) | 29/09/2011 | 11/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA) - OPERA | Crohn's Disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Portugal;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Norway;Germany;Korea, Republic of;Sweden | |||
| 1489 | EUCTR2010-023034-23-HU (EUCTR) | 20/09/2011 | 10/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1490 | NCT01489943 (ClinicalTrials.gov) | September 19, 2011 | 1/12/2011 | A Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects | A Single Centre, Single Sequence, Open-Label, Repeat-Dose Study to Investigate the Effect of GSK1605786 on Hepatic Cytochrome P450, and BCRP and OATP1B1 Transport in Healthy Adult Subjects | Crohn's Disease | Drug: GSK1605786 500 mg;Drug: Midazolam 3 mg;Drug: Pioglitazone 15 mg;Drug: Omeprazole 40 mg;Drug: Rosuvastatin 10 mg | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 24 | Phase 1 | United States |
| 1491 | EUCTR2010-023034-23-GB (EUCTR) | 15/09/2011 | 16/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1492 | EUCTR2010-022759-42-ES (EUCTR) | 13/09/2011 | 27/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1493 | EUCTR2010-022760-12-DE (EUCTR) | 13/09/2011 | 26/05/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1310 | Phase 3 | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1494 | NCT01369355 (ClinicalTrials.gov) | September 13, 2011 | 7/6/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease;Colitis;IBD;Inflammatory Bowel Disease | Drug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12w | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 99 Years | All | 1282 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Czech Republic |
| 1495 | EUCTR2011-000854-44-HU (EUCTR) | 06/09/2011 | 02/06/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 609 | Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Sweden | |||
| 1496 | EUCTR2010-023437-30-PT (EUCTR) | 02/09/2011 | 26/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden | ||
| 1497 | EUCTR2010-024638-48-PT (EUCTR) | 02/09/2011 | 26/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 1498 | EUCTR2010-022760-12-ES (EUCTR) | 02/09/2011 | 03/11/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn?s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn?s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand | ||
| 1499 | EUCTR2010-022758-18-ES (EUCTR) | 01/09/2011 | 22/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Hungary;Germany;European Union;Ireland;Italy;Austria;South Africa;Australia;Brazil;Israel;Czech Republic;United Kingdom;New Zealand;Serbia;Canada;Iceland;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States | ||
| 1500 | NCT01388933 (ClinicalTrials.gov) | September 2011 | 5/7/2011 | A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease | A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease | Crohn's Disease | Drug: TU-100;Drug: Matching Placebo | Tsumura USA | INC Research | Terminated | 18 Years | 75 Years | Both | 79 | Phase 2 | United States |
| 1501 | EUCTR2010-023034-23-DK (EUCTR) | 30/08/2011 | 11/07/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden | |||
| 1502 | EUCTR2010-022759-42-DE (EUCTR) | 29/08/2011 | 26/05/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 612 | Phase 3 | United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 1503 | EUCTR2010-022758-18-DE (EUCTR) | 24/08/2011 | 26/05/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1504 | EUCTR2010-022758-18-CZ (EUCTR) | 22/08/2011 | 08/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1505 | EUCTR2010-022760-12-CZ (EUCTR) | 17/08/2011 | 08/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;New Zealand;Japan;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;France;Italy;Russian Federation;Israel;Ireland;Spain;Serbia;United States | ||
| 1506 | EUCTR2010-022758-18-DK (EUCTR) | 15/08/2011 | 25/07/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1507 | EUCTR2010-022760-12-DK (EUCTR) | 15/08/2011 | 26/08/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1508 | EUCTR2010-023797-39-GB (EUCTR) | 12/08/2011 | 16/07/2011 | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate INN or Proposed INN: Iron sulphate Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection INN or Proposed INN: iron(III)- hydroxide dextran complex | Barts Health NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1509 | EUCTR2010-022759-42-HU (EUCTR) | 09/08/2011 | 10/08/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 | Moderately to severely active Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 612 | Phase 3 | United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of | ||
| 1510 | EUCTR2010-022759-42-IT (EUCTR) | 09/08/2011 | 23/01/2012 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | JANSSEN-CILAG INTERNATIONAL N.V. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Spain;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1511 | EUCTR2010-022760-12-IT (EUCTR) | 09/08/2011 | 30/03/2012 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Phase 3 | Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1512 | EUCTR2010-022760-12-HU (EUCTR) | 09/08/2011 | 08/07/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1513 | EUCTR2010-022758-18-IT (EUCTR) | 09/08/2011 | 22/06/2012 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: USTEKINUMAB | JANSSEN-CILAG INTERNATIONAL N.V. | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1514 | EUCTR2010-018431-18-CZ (EUCTR) | 08/08/2011 | 19/05/2011 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 1515 | EUCTR2011-000854-44-BE (EUCTR) | 04/08/2011 | 20/04/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 2 | Latvia;Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria | ||
| 1516 | EUCTR2010-023589-39-GB (EUCTR) | 02/08/2011 | 19/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Austria;Germany;United Kingdom | ||
| 1517 | EUCTR2010-022758-18-HU (EUCTR) | 02/08/2011 | 10/08/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of | ||
| 1518 | EUCTR2010-022760-12-IS (EUCTR) | 02/08/2011 | 08/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1275 | Phase 3 | Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1519 | NCT01352221 (ClinicalTrials.gov) | August 2011 | 10/5/2011 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 2) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Crohn's Disease | Drug: ST10;Drug: Placebo oral capsule | Shield Therapeutics | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | Austria;United Kingdom |
| 1520 | NCT02619552 (ClinicalTrials.gov) | August 2011 | 28/10/2015 | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Crohn's Disease;IBD | Drug: Anti-TNF;Drug: Steroids | University of Maryland, Baltimore | Vanderbilt University;Milton S. Hershey Medical Center;Mercy Medical Center | Completed | 18 Years | N/A | All | 50 | United States | |
| 1521 | EUCTR2010-022760-12-AT (EUCTR) | 28/07/2011 | 01/06/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI | Moderately to severely active Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 1310 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Serbia;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan | ||
| 1522 | EUCTR2010-022758-18-AT (EUCTR) | 28/07/2011 | 01/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Stelara Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 703 | Phase 3 | Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of | ||
| 1523 | EUCTR2010-022215-19-GB (EUCTR) | 21/07/2011 | 23/06/2011 | Combined growth hormone and IGF1 therapy in paediatric Crohn'd disease | A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease - Combination rhGH + rhIGF-1 in childhood/adolescent Crohn’s | Impaired growth in Paediatric Crohn's disease MedDRA version: 14.1;Level: LLT;Classification code 10011398;Term: Crohn's;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Increlex Product Name: Increlex 10mg/ml solution for injection INN or Proposed INN: Mecasermin [rDNA Origin] 10mg/ml solution Other descriptive name: Recombinant human Insulin-like Growth Factor Trade Name: NutropinAq® Product Name: NutropinAq 10mg/2ml solution for injection INN or Proposed INN: Somatropin(rhGH) Other descriptive name: recombinant growth hormone | Greater Glasgow & Clyde NHS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United Kingdom | ||
| 1524 | EUCTR2011-002821-24-IT (EUCTR) | 21/07/2011 | 27/02/2012 | Study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. | Prospective pharmacodynamic study on patients with moderate, active Crohn’s disease treated with Rifaximin-EIR 400 mg tablets. - RETIC-PD/006/2011 | Treatment of active, moderate Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Rifaximin-EIR Product Code: NA INN or Proposed INN: RIFAXIMIN Other descriptive name: NA | ALFA WASSERMANN | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1525 | EUCTR2010-023034-23-GR (EUCTR) | 19/07/2011 | 20/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 INSUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 1526 | EUCTR2011-000854-44-NO (EUCTR) | 19/07/2011 | 01/06/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 609 | Phase 2 | Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia;Netherlands;Norway;Sweden | ||
| 1527 | EUCTR2010-024638-48-ES (EUCTR) | 15/07/2011 | 18/11/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | MULTICENTER OPEN-LABEL EXTENSION STUDY FOR PF-00547659(OPERA II) - OPERA II | Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: No aplicable Product Code: PF-00547659 INN or Proposed INN: No aplicable Other descriptive name: No aplicable | PFIZER, S.L.U. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Serbia;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden | |||
| 1528 | EUCTR2011-002640-27-IT (EUCTR) | 14/07/2011 | 09/02/2012 | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn’s disease (Ileo-Colitis) | A phase II multicenter, randomized, double-blind, controlled vs placebo, dose-finding study on the efficacy and safety of GED-0301, in patients with active Crohn?s disease (Ileo-Colitis) - I.G.O.N. 1 STUDY | ACTIVE CROHN'S DISEASE MedDRA version: 14.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0301 Product Code: NA INN or Proposed INN: NA Other descriptive name: NA | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany;Italy | |||
| 1529 | EUCTR2010-018431-18-HU (EUCTR) | 14/07/2011 | 13/05/2011 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Netherlands;Germany;New Zealand;Denmark;Australia;Belgium;Poland;Czech Republic;Hungary;France;Italy;United Kingdom;Israel;Austria | |||
| 1530 | EUCTR2009-016488-12-NL (EUCTR) | 12/07/2011 | 26/10/2010 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy | ||
| 1531 | EUCTR2010-022758-18-IS (EUCTR) | 08/07/2011 | 08/06/2011 | Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 | Moderately to severely active Crohn's disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 675 | Phase 3 | Hungary;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Germany;Iceland;Italy;United Kingdom | ||
| 1532 | NCT01298492 (ClinicalTrials.gov) | July 1, 2011 | 26/1/2011 | A Study To Monitor Long-Term Treatment With PF-00547659 | A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II | Crohn's Disease | Drug: PF-00547659 | Shire | NULL | Completed | 18 Years | 75 Years | All | 268 | Phase 2 | United States;Austria;Belgium;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Bulgaria;Portugal;Sweden |
| 1533 | NCT01369329 (ClinicalTrials.gov) | July 2011 | 7/6/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1) | Crohn's Disease;IBD;Colitis;Inflammatory Bowel Disease | Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg;Drug: Group 1: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 769 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Serbia;South Africa;Spain;United Kingdom |
| 1534 | NCT01369342 (ClinicalTrials.gov) | July 2011 | 7/6/2011 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2) | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2) | Crohn's Disease;Inflammatory Bowel Disease;IBD;Colitis | Drug: Group 1: Placebo;Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 99 Years | All | 640 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Croatia;France;Germany;Hungary;Iceland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Ireland |
| 1535 | EUCTR2011-002061-38-BE (EUCTR) | 29/06/2011 | 08/06/2011 | Treating patients with infliximab based on their trough levels | A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT | 2) Crohn's disease and ulcerative colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade Product Code: Remicade INN or Proposed INN: INFLIXIMAB | Katholieke Universiteit Leuven | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Belgium | |||
| 1536 | EUCTR2010-020836-21-PL (EUCTR) | 29/06/2011 | 28/06/2011 | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NNC0142-0000-0002 Product Code: NNC142-0002 INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hungary;European Union;Canada;Belgium;Poland;Israel;Russian Federation | |||
| 1537 | EUCTR2010-023589-39-AT (EUCTR) | 22/06/2011 | 17/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | |||
| 1538 | EUCTR2010-023437-30-ES (EUCTR) | 03/06/2011 | 13/06/2011 | Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Enfermedad de Crohn Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: PF-00547659 Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: No aplicable | PFIZER SLU | NULL | Not Recruiting | Female: yes Male: yes | 240 | Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden | |||
| 1539 | EUCTR2010-023034-23-IE (EUCTR) | 03/06/2011 | 07/04/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 1540 | EUCTR2010-023437-30-AT (EUCTR) | 01/06/2011 | 25/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of | |||
| 1541 | EUCTR2010-024638-48-SE (EUCTR) | 01/06/2011 | 25/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Portugal;Serbia;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Germany;Netherlands;Norway;Sweden | ||
| 1542 | EUCTR2010-023437-30-SE (EUCTR) | 01/06/2011 | 25/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | South Africa;Germany;Netherlands;United States;Portugal;Serbia;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;Norway;Sweden | ||
| 1543 | EUCTR2010-024638-48-AT (EUCTR) | 01/06/2011 | 25/05/2011 | A7281007; Multi-center open-label extension study for PF-00547659 | A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II | Crohn’s disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Serbia;Portugal;United States;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Norway;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 1544 | NCT01345318 (ClinicalTrials.gov) | June 2011 | 28/4/2011 | B0151005 Open-Label Extension Study | A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii) | Crohn's Disease | Biological: PF-04236921 | Pfizer | NULL | Completed | N/A | N/A | All | 191 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Ireland;Israel;Italy;New Zealand;Switzerland;United Kingdom |
| 1545 | NCT01355614 (ClinicalTrials.gov) | June 2011 | 16/5/2011 | A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients | A Multi-center, Randomized, Double-blind, Active Controlled Study to Assess Efficacy, Safety and Tolerability of the Anti-IL13 Monoclonal Antibody QAX576 in the Treatment of Perianal Fistulas in Patients Suffering From Crohn's Disease | Crohn's Disease | Drug: QAX576;Drug: Infliximab | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | Germany;Switzerland |
| 1546 | NCT01582568 (ClinicalTrials.gov) | June 2011 | 19/4/2012 | EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment | EUS Evaluation of Perianal and Peri-rectal Fistulizing Crohn's Disease With CERTOLIZUMAB Treatment | Crohns Disease | Drug: Certolizumab | Baylor College of Medicine | UCB Pharma | Terminated | 18 Years | 70 Years | Both | 1 | United States | |
| 1547 | EUCTR2010-022384-35-BE (EUCTR) | 30/05/2011 | 07/12/2010 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | ||
| 1548 | EUCTR2010-022383-12-BE (EUCTR) | 30/05/2011 | 07/12/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | ||
| 1549 | EUCTR2010-023437-30-BE (EUCTR) | 27/05/2011 | 25/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Portugal;Slovenia;Slovakia;Spain;Austria;France;Canada;Belgium;Poland;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;Korea, Republic of | |||
| 1550 | EUCTR2010-020881-53-ES (EUCTR) | 25/05/2011 | 01/12/2010 | Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease. | Una evaluación a largo plazo de la seguridad y la eficacia del tratamiento con AMG 827 en sujetos con enfermedad de Crohn. /A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease. | Crohn's disease / Enfermedad de Crohn MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Netherlands;Belgium;Spain | |||
| 1551 | EUCTR2010-022384-35-CZ (EUCTR) | 13/05/2011 | 31/03/2011 | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - SHIELD 3 | Subjects with Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1552 | EUCTR2010-022383-12-CZ (EUCTR) | 12/05/2011 | 30/03/2011 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease - SHIELD 2 | Subjects with Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1553 | NCT01316939 (ClinicalTrials.gov) | May 9, 2011 | 3/3/2011 | GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease | A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: GSK1605786A;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 229 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland |
| 1554 | EUCTR2010-022384-35-DK (EUCTR) | 06/05/2011 | 01/04/2011 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Japan;Sweden | ||
| 1555 | EUCTR2011-000854-44-SE (EUCTR) | 02/05/2011 | 01/03/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat servral hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but either the doctor or the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 609 | Netherlands;Norway;Sweden;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Latvia | |||
| 1556 | ChiCTR-TRC-11001321 | 2011-05-01 | 2011-05-01 | Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease | Effect of ?-3 Fish Oil Fat on Perioperative Immunity in Patients with Crohn's Disease | Crohn's disease;ICD:K50.9 | control group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose/insulin ratio is 5:1. In this group, medium-long chain triglyceride will be used.;?-3 Fat group:Total parenteral nutrition (TPN) will be administrated to patients from day1 to day7 after the operation. Non-protein energy of the TPN is 120kJ/kg/d, of which 60% is supplied by glucose and 40% by fat emulsion. Amino acid of the TPN is 0.8-1.0g/kg/d. Electrolyte, vitamins, trace elements will be added into the TPN. Glucose-insulin ratio is 5:1. In this group, medium-long chain triglyceride and ?-3 fish oil fat (Omegaven); | The First Affiliated Hospital of Sun Yat-sen University | NULL | Completed | 14 | 75 | Both | control group:30;?-3 Fat group:30; | China | |
| 1557 | NCT01346826 (ClinicalTrials.gov) | May 2011 | 2/5/2011 | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial | Crohn's Disease;Ulcerative Colitis | Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion | Asan Medical Center | NULL | Completed | 16 Years | 80 Years | Both | 145 | Phase 4 | Korea, Republic of |
| 1558 | EUCTR2010-019996-32-BG (EUCTR) | 27/04/2011 | 24/02/2011 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 | Moderate to severe Crohn's Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 1559 | EUCTR2010-022383-12-DK (EUCTR) | 08/04/2011 | 02/03/2011 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1560 | NCT01276509 (ClinicalTrials.gov) | April 6, 2011 | 12/1/2011 | Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera) | Crohn's Disease | Drug: PF-00547659 SC injection | Shire | NULL | Completed | 18 Years | 75 Years | All | 265 | Phase 2 | United States;Austria;Belgium;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Netherlands;Norway;Poland;Serbia;Slovakia;South Africa;Spain;Croatia;Portugal;Sweden |
| 1561 | EUCTR2009-016488-12-DE (EUCTR) | 04/04/2011 | 12/11/2010 | Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of | ||
| 1562 | NCT01318993 (ClinicalTrials.gov) | April 1, 2011 | 3/3/2011 | Open-Label Extension Study of GSK1605786A | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease | Crohn's Disease | Drug: GSK1605786A | GlaxoSmithKline | NULL | Terminated | 18 Years | N/A | All | 399 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Japan;Korea, Republic of;New Zealand;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Argentina;Brazil;Czech Republic;Greece;Ireland |
| 1563 | NCT01341808 (ClinicalTrials.gov) | April 2011 | 25/4/2011 | Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients | Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis A | Biological: Epaxal Berna (virosomal hepatitis A vaccine) | Asan Medical Center | NULL | Completed | 18 Years | 40 Years | Both | 493 | Phase 4 | Korea, Republic of |
| 1564 | NCT02504255 (ClinicalTrials.gov) | April 2011 | 20/7/2015 | Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease | Evaluation of Immunological Markers, Inflammatory and Clinical Relapse Psychological Predictive During Crohn's Disease : A Multicenter Cohort | Crohn Disease | Biological: Biological samplings;Other: Questionnaires | Hospices Civils de Lyon | NULL | Completed | 18 Years | N/A | Both | 144 | France | |
| 1565 | NCT01338740 (ClinicalTrials.gov) | April 2011 | 18/4/2011 | Switching From Adalimumab to Infliximab | Prospective Study to Assess the Efficacy of Switching to Infliximab in Moderately to Severely Active Chrohn's Disease Patients With Primary Non-response or Loss of Response to Adalimumab | Crohn's Disease | Drug: Adalimumab and Infliximab | University Hospital, Ghent | Abbott | Recruiting | 18 Years | 75 Years | Both | 40 | N/A | Belgium |
| 1566 | NCT01345799 (ClinicalTrials.gov) | April 2011 | 28/4/2011 | A Study of TRK-170 for the Treatment of Crohn's Disease | A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease | Crohn's Disease | Drug: TRK-170;Drug: Placebo | Toray Industries, Inc | NULL | Completed | 18 Years | 50 Years | Both | 123 | Phase 2 | Belgium;Bulgaria;Czech Republic;France;Hungary;Latvia;Netherlands;Norway;Poland;Romania;Serbia;Sweden;Ukraine |
| 1567 | EUCTR2010-019996-32-DE (EUCTR) | 31/03/2011 | 22/11/2010 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective andsafe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 1568 | EUCTR2010-020137-10-BE (EUCTR) | 23/03/2011 | 04/10/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1569 | EUCTR2010-022384-35-GB (EUCTR) | 22/03/2011 | 30/12/2010 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | ||
| 1570 | EUCTR2010-019996-32-HU (EUCTR) | 18/03/2011 | 31/01/2011 | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 12.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | Hungary;Belgium;Bulgaria;Netherlands;Germany | ||
| 1571 | EUCTR2010-022383-12-SE (EUCTR) | 01/03/2011 | 15/12/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;Denmark;Netherlands;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Argentina;Poland;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 1572 | EUCTR2010-022384-35-SE (EUCTR) | 01/03/2011 | 15/12/2010 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;Japan;New Zealand;Sweden | |||
| 1573 | EUCTR2009-010727-91-DE (EUCTR) | 01/03/2011 | 05/06/2012 | Colesevelam, which is a medication which binds bile acid, to test in patients with Crohns disease | Colesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten) | Morbus Crohn MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Cholestagel Product Name: Cholestagel Product Code: EU/1/03/268/002 INN or Proposed INN: Colesevelam | LMU München, Campus Großhadern | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1574 | NCT01258205 (ClinicalTrials.gov) | February 28, 2011 | 9/12/2010 | Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects | A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 139 | AstraZeneca | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 1 | United States;Australia |
| 1575 | EUCTR2010-022383-12-GB (EUCTR) | 24/02/2011 | 23/12/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;Norway;Sweden | ||
| 1576 | EUCTR2009-016488-12-SK (EUCTR) | 23/02/2011 | 27/10/2010 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy | ||
| 1577 | EUCTR2010-022383-12-NL (EUCTR) | 16/02/2011 | 29/10/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A Other descriptive name: na | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;Japan;New Zealand;Sweden | |||
| 1578 | EUCTR2010-022382-10-NL (EUCTR) | 16/02/2011 | 29/10/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: GSK1605786A Product Code: GSK1605786A Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Spain;Belgium;Austria;Denmark;Norway;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 1579 | EUCTR2010-024528-12-DK (EUCTR) | 14/02/2011 | 24/01/2011 | Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT | Kontrast UltraLydsskanning af Tyndtarmen hos patienter med Crohns sygdom – et pilotstudie (KULT) - KULT | Morbus Crohn disease with signs of activity in the small bowel. MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: SonoVue Other descriptive name: SULFUR HEXAFLUORIDE | Henning Glerup | NULL | Not Recruiting | Female: yes Male: yes | 5 | Phase 2 | Denmark | ||
| 1580 | EUCTR2010-019996-32-CZ (EUCTR) | 11/02/2011 | 26/11/2010 | A phase II, randomized, double-blind, placebo-controlled study toevaluate the clinical efficacy, safety and immunogenicity ofNeovacs'TNFa-Kinoid in adult subjects with Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNFa-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Romania;Croatia;Bulgaria;Netherlands;Germany | ||
| 1581 | NCT01235689 (ClinicalTrials.gov) | February 11, 2011 | 4/11/2010 | Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab;Drug: Prednisone;Drug: Azathioprine | AbbVie (prior sponsor, Abbott) | NULL | Completed | 18 Years | 75 Years | All | 252 | Phase 3 | Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 1582 | EUCTR2009-016488-12-BE (EUCTR) | 08/02/2011 | 25/11/2010 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | Czech Republic;Hungary;Slovakia;Belgium;Austria;Germany;Netherlands;Italy | ||
| 1583 | EUCTR2010-022382-10-BE (EUCTR) | 07/02/2011 | 07/12/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden | ||
| 1584 | EUCTR2009-016488-12-CZ (EUCTR) | 04/02/2011 | 25/11/2010 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Netherlands;Italy | ||
| 1585 | EUCTR2010-022384-35-DE (EUCTR) | 02/02/2011 | 10/11/2010 | A 25 month study of a potential new medicine (GSK1605786A) for the treatment of Crohn’s disease | An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease - Open label extension study | Subjects with Crohn’s Disease MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Portugal;United States;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | |||
| 1586 | NCT01290042 (ClinicalTrials.gov) | February 2011 | 27/1/2011 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease. | Ulcerative Colitis;Crohn's Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | NULL | Completed | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia |
| 1587 | NCT01287897 (ClinicalTrials.gov) | February 2011 | 31/1/2011 | A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante) | Crohn's Disease | Drug: PF-04236921 SC injection | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 250 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden |
| 1588 | NCT01203631 (ClinicalTrials.gov) | February 2011 | 15/9/2010 | Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease | A Randomised, Double-blind, Parallel-group, Placebo Controlled Induction Trial to Assess the Clinical Efficacy and Safety of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease | Inflammation;Crohn's Disease | Drug: NNC 0142-0000-0002;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 75 Years | Both | 78 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Poland;Russian Federation |
| 1589 | NCT01291810 (ClinicalTrials.gov) | February 2011 | 17/12/2010 | Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFa-Kinoid in Adult Subjects With Crohn's Disease | Crohn's Disease | Biological: TNF Kinoid;Biological: WFI | Neovacs | NULL | Completed | 18 Years | 65 Years | Both | 66 | Phase 2 | Belgium;Bulgaria;Croatia;Czech Republic;France;Germany;Hungary;Netherlands;Romania |
| 1590 | EUCTR2010-022382-10-SE (EUCTR) | 20/01/2011 | 09/11/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1591 | EUCTR2010-022382-10-DK (EUCTR) | 19/01/2011 | 10/12/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1592 | EUCTR2010-020881-53-BE (EUCTR) | 18/01/2011 | 24/11/2010 | Safety Study in Subjects With Crohn's Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn’s Disease | Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands | ||
| 1593 | EUCTR2010-019973-13-DE (EUCTR) | 14/01/2011 | 30/09/2010 | A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients | A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease | Treatment of perianal fistulas in patients suffering from Crohn's Disease. MedDRA version: 14.0;Level: PT;Classification code 10016717;Term: Fistula;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Code: QAX576 Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 23 | Phase 2 | Germany;Switzerland | ||
| 1594 | EUCTR2010-019996-32-BE (EUCTR) | 12/01/2011 | 04/10/2010 | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’TNFa-Kinoid in adult subjects with Crohn’s Disease | Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 1595 | EUCTR2010-022382-10-DE (EUCTR) | 11/01/2011 | 22/10/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn’s Disease. | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Germany;Norway;Netherlands;Japan;Sweden | |||
| 1596 | EUCTR2010-022017-26-GB (EUCTR) | 07/01/2011 | 08/12/2010 | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease - Alternate-day corticosteroid regimen in children with Crohn’s disease | Crohn's disease MedDRA version: 12.;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: Prednisolone INN or Proposed INN: Prednisolone | Central Manchester University Hospitals Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 27 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 1597 | EUCTR2010-020836-21-BE (EUCTR) | 07/01/2011 | 15/09/2010 | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NNC0142-0000-0002 Product Code: NNC142-0002 INN or Proposed INN: N/A | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Hungary;European Union;Canada;Poland;Belgium;Israel;Russian Federation | ||
| 1598 | EUCTR2010-022382-10-GB (EUCTR) | 06/01/2011 | 12/10/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden | ||
| 1599 | EUCTR2010-022383-12-NO (EUCTR) | 06/01/2011 | 02/12/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: GSK1605786A Product Code: GSK1605786A INN or Proposed INN: GSK1605786A Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamidesodium | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden | ||
| 1600 | EUCTR2009-016488-12-AT (EUCTR) | 05/01/2011 | 18/11/2010 | Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | United States;Slovakia;Turkey;Austria;Israel;Italy;France;Hungary;Czech Republic;Canada;Malaysia;Poland;Belgium;Australia;South Africa;Netherlands;Germany;Norway;New Zealand;Korea, Republic of | ||
| 1601 | NCT01316601 (ClinicalTrials.gov) | January 2011 | 14/3/2011 | A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease | Crohn's Disease | Drug: QAX567 | Gerhard Rogler | Novartis Pharmaceuticals | Completed | 18 Years | N/A | Both | 3 | Phase 2 | Switzerland | |
| 1602 | NCT01275508 (ClinicalTrials.gov) | January 2011 | 7/1/2011 | Safety and Tolerability of FITC-Adalimumab Administration During Confocal Laser Endomicroscopy of the Gut | Prospective, Monocentric, Open-label, Clinical Phase 1 Study to Demonstrate the Safety and Tolerability of FITC-Adalimumab After Single Topical Administration to the Intestinal Mucosa During Endomicroscopy in Patients With Crohn's Disease | Crohn's Disease | Drug: FITC-Adalimumab | University of Erlangen-Nürnberg Medical School | Abbott | Completed | 18 Years | 70 Years | Both | 25 | Phase 1/Phase 2 | Germany |
| 1603 | NCT01245088 (ClinicalTrials.gov) | January 2011 | 19/11/2010 | Chondroitin Sulfate for Crohn's Disease | A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease | Crohn's Disease | Drug: chondroitin sulfate | University Hospital Case Medical Center | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 1/Phase 2 | United States |
| 1604 | EUCTR2009-016488-12-HU (EUCTR) | 28/12/2010 | 10/11/2010 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 3 | Czech Republic;Hungary;Belgium;Austria;Germany;Netherlands;Italy | ||
| 1605 | EUCTR2010-022382-10-CZ (EUCTR) | 22/12/2010 | 04/11/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Japan;Sweden | |||
| 1606 | NCT01277666 (ClinicalTrials.gov) | December 20, 2010 | 13/1/2011 | A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease | A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease | Crohn's Disease | Drug: GSK1605786A;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 608 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Norway;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Czech Republic |
| 1607 | EUCTR2010-020137-10-NL (EUCTR) | 17/12/2010 | 23/12/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Netherlands;Germany;Sweden | ||
| 1608 | NCT01266785 (ClinicalTrials.gov) | December 2010 | 23/12/2010 | Infliximab, Regulatory T Cells, IL2 and Crohn's Disease | Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease | Crohn's Disease | Drug: Infliximab | Oregon Health and Science University | Centocor, Inc. | Withdrawn | 18 Years | 70 Years | All | 0 | N/A | United States |
| 1609 | NCT01199302 (ClinicalTrials.gov) | December 2010 | 9/9/2010 | Safety Study in Subjects With Crohn's Disease | A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease | Crohn's Disease | Drug: AMG 827 | Amgen | NULL | Terminated | N/A | N/A | Both | 67 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain |
| 1610 | NCT01233960 (ClinicalTrials.gov) | November 29, 2010 | 2/11/2010 | Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease | A Multicenter, Open-label Study to Evaluate the Safety of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects Who Have Received Previous Remestemcel-L Induction Treatment for Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 73 | Phase 3 | United States;Australia;New Zealand |
| 1611 | EUCTR2010-019544-39-ES (EUCTR) | 25/11/2010 | 03/09/2010 | Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease | Estudio aleatorizado, a doble ciego, controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de AMG 827 en sujetos con enfermedad de Crohn de moderada a grave / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn's Disease | Crohn's disease / Enfermedad de Crohn MedDRA version: 12.1;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated | Product Name: AMG 827 Product Code: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 216 | Netherlands;Belgium;France;Spain | |||
| 1612 | EUCTR2010-018431-18-BE (EUCTR) | 19/11/2010 | 28/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 1613 | EUCTR2010-020137-10-CZ (EUCTR) | 08/11/2010 | 04/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1614 | NCT01190839 (ClinicalTrials.gov) | November 2010 | 12/8/2010 | A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence | Crohn's Disease | Biological: Infliximab;Drug: Placebo | Janssen Biotech, Inc. | NULL | Terminated | 18 Years | 99 Years | All | 297 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;New Zealand;Poland;United Kingdom;Denmark;Spain |
| 1615 | NCT01224171 (ClinicalTrials.gov) | November 2010 | 18/10/2010 | Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 416 | Phase 3 | United States;Canada;Puerto Rico |
| 1616 | NCT01094613 (ClinicalTrials.gov) | November 2010 | 25/3/2010 | Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease | MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease | Crohn's Disease | Drug: Delayed Release 6 mercaptopurine;Drug: 6 Mercaptopurine | Teva GTC | NULL | Terminated | 18 Years | 75 Years | Both | 70 | Phase 1/Phase 2 | Israel |
| 1617 | NCT01279577 (ClinicalTrials.gov) | November 2010 | 18/1/2011 | Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease | Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease | Crohn´s Disease | Drug: Low dose TSO;Drug: Medium dose TSO;Drug: High dose TSO;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 254 | Phase 2 | Germany |
| 1618 | EUCTR2010-018431-18-NL (EUCTR) | 28/10/2010 | 20/09/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | |||
| 1619 | EUCTR2006-000720-13-DE (EUCTR) | 27/10/2010 | 29/01/2010 | Study to evaluate the effectiveness and safety of 3 doses of embryonated eggs of the porcine whipworm compared to placebo (dummy drug) in the treatment of active Crohn's disease. | Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 250 Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 2500 Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 7500 Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Switzerland | ||
| 1620 | EUCTR2010-020836-21-HU (EUCTR) | 26/10/2010 | 28/09/2010 | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | A randomised, double-blind, parallel-group, placebo-controlled, induction trial to assess the clinical efficacy and safety of NNC0142-0000-0002 in subjects with moderately to severely active Crohn’s disease | Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: NNC0142-0000-0002 Product Code: NNC142-0002 | Novo Nordisk A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Hungary;Poland;Belgium | |||
| 1621 | EUCTR2010-020137-10-ES (EUCTR) | 20/10/2010 | 20/08/2010 | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Estudio multicéntrico abierto de la eficacia y la seguridad para evaluar dos algoritmos detratamiento en pacientes con enfermedad de Crohn moderada a grave.An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Enfermedad de Crohn.Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1622 | EUCTR2006-002078-23-IE (EUCTR) | 20/10/2010 | 25/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1623 | EUCTR2006-000720-13-CZ (EUCTR) | 18/10/2010 | 30/06/2010 | Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease. | Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 250 Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 2500 Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 7500 Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Switzerland | ||
| 1624 | EUCTR2010-020137-10-FR (EUCTR) | 14/10/2010 | 23/08/2010 | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1625 | EUCTR2010-020137-10-DE (EUCTR) | 05/10/2010 | 20/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1626 | EUCTR2010-019544-39-BE (EUCTR) | 04/10/2010 | 17/08/2010 | AMG 827 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease | Crohn’s disease MedDRA version: 14.0;Level: LLT;Classification code 10011408;Term: Crohns disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Australia;Netherlands | ||
| 1627 | NCT01231217 (ClinicalTrials.gov) | October 2010 | 27/10/2010 | Green Tea in Crohn's Disease | Crohn's Disease | Other: Green tea (Camellia sinensis);Other: Coffee | University Hospital Heidelberg | NULL | Recruiting | 18 Years | N/A | Both | 80 | N/A | Germany | |
| 1628 | NCT01203254 (ClinicalTrials.gov) | October 2010 | 15/9/2010 | Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease | Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease | Crohns Disease;Bile Acid Malabsorption | Drug: Colesevelam;Drug: Placebo | Florian Beigel | NULL | Terminated | 18 Years | 65 Years | Both | 34 | Phase 4 | Germany |
| 1629 | EUCTR2010-020137-10-GB (EUCTR) | 20/09/2010 | 19/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1630 | EUCTR2010-020137-10-AT (EUCTR) | 16/09/2010 | 11/08/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1631 | EUCTR2010-020137-10-SE (EUCTR) | 15/09/2010 | 27/07/2010 | Efficacy and Safety of Two Treatment Models in Subjects With Moderate to Severe Crohn's Disease (CALM) | An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease - CALM | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprin-ratiopharm 25mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Azathioprin-ratiopharm 50 mg Filmtabletten Product Name: azathioprine INN or Proposed INN: Azathioprine Other descriptive name: AZATHIOPRINE Trade Name: Decortin 5 mg INN or Proposed INN: PREDNISONE Trade Name: Decortin 20 mg INN or Proposed INN: PREDNISONE | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Sweden | ||
| 1632 | EUCTR2010-018431-18-FR (EUCTR) | 15/09/2010 | 09/07/2010 | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 3 | France;Czech Republic;Hungary;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 1633 | NCT01233570 (ClinicalTrials.gov) | September 2010 | 2/11/2010 | Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease | Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease | Crohn Disease | Drug: Tacrolimus | University of Aberdeen | NULL | Completed | 12 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 1634 | NCT01187459 (ClinicalTrials.gov) | September 2010 | 20/8/2010 | Vitamin D in Pediatric Crohn's Disease | Vitamin D in Pediatric Crohn's Disease | Vitamin D Deficiency | Dietary Supplement: Vitamin D | University of British Columbia | McMaster University | Completed | 8 Years | 18 Years | Both | 87 | Phase 4 | Canada |
| 1635 | NCT01215890 (ClinicalTrials.gov) | September 2010 | 5/10/2010 | Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease | A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients | Crohn's Disease;Low Bone Mineral Density | Drug: risedronate;Drug: placebo | University of Alberta | NULL | Completed | 18 Years | N/A | Both | Phase 4 | Canada | |
| 1636 | EUCTR2010-018431-18-DE (EUCTR) | 23/08/2010 | 24/06/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | |||
| 1637 | EUCTR2010-018431-18-GB (EUCTR) | 16/08/2010 | 06/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand | ||
| 1638 | EUCTR2010-018431-18-AT (EUCTR) | 06/08/2010 | 05/07/2010 | A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence | Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence - PREVENT | Crohn’s disease (CD) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: REMICADE INN or Proposed INN: INFLIXIMAB Other descriptive name: n/a | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand | |||
| 1639 | NCT01155362 (ClinicalTrials.gov) | August 2010 | 26/5/2010 | A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | A Phase 2a, Randomized, Double Blind, Placebo Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease | Crohn's Disease | Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion;Drug: Vehice Control | Celularity Incorporated | Celgene Corporation | Completed | 18 Years | 75 Years | All | 50 | Phase 2 | United States |
| 1640 | NCT01190410 (ClinicalTrials.gov) | August 2010 | 25/8/2010 | Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol | An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035 | Crohn's Disease | Drug: certolizumab pegol | UCB Pharma | NULL | Completed | 6 Years | 17 Years | All | 16 | Phase 2 | United States;Australia;Canada |
| 1641 | NCT01261286 (ClinicalTrials.gov) | August 2010 | 14/12/2010 | Drug-Disease Interaction in Crohn's Disease | Pharmacodynamics and Pharmacokinetics of Verapamil in Crohn's Disease Patients | Crohn's Disease | Drug: verapamil | University of Alberta | NULL | Completed | 18 Years | 65 Years | Both | Phase 1 | Canada | |
| 1642 | NCT01611805 (ClinicalTrials.gov) | July 22, 2010 | 12/4/2012 | Japanese Phase I of GSK1605786 | A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject | Crohn's Disease | Drug: GSK1605786;Drug: GSK1605786 Placebo | GlaxoSmithKline | NULL | Completed | 20 Years | 55 Years | Male | 30 | Phase 1 | Australia |
| 1643 | NCT01150890 (ClinicalTrials.gov) | July 2010 | 24/6/2010 | AMG 827 in Subjects With Moderate to Severe Crohn's Disease | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: AMG 827 350 MG;Drug: AMG 827 210 MG;Drug: AMG 827 700 MG;Drug: Placebo | Amgen | NULL | Terminated | 18 Years | 65 Years | Both | 130 | Phase 2 | United States;Australia;Belgium;Canada;France;Netherlands;Poland;Spain |
| 1644 | NCT01510431 (ClinicalTrials.gov) | July 2010 | 9/1/2012 | Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease | An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease | Crohn's Disease | Drug: PROCHYMAL (remestemcel-L) | Mesoblast, Inc. | NULL | No longer available | 18 Years | 70 Years | All | United States | ||
| 1645 | EUCTR2006-000720-13-DK (EUCTR) | 22/06/2010 | 17/03/2010 | Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease. | Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 250 Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 2500 Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 7500 Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Czech Republic;Austria;Denmark;Germany;Switzerland | ||
| 1646 | EUCTR2009-015680-14-NL (EUCTR) | 18/05/2010 | 27/07/2010 | Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | Allogeneic Bone Marrow Derived Mesenchymal Stem Cellsfor the Treatment of Fistulas in Patients withRefractory Perianal Crohn’s Disease - allo bmMSCs CD fistula | single or multiple draining perianal fistulas as a result of Crohn's Disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Bone Marrow Derived Mesenchymal Stem cells (MSCs) Product Code: NA | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 1647 | EUCTR2009-011621-14-DE (EUCTR) | 12/05/2010 | 26/01/2010 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - n/a | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria | |||
| 1648 | NCT01114607 (ClinicalTrials.gov) | May 5, 2010 | 29/4/2010 | A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects | A Single Dose, Randomized, Five-Period Crossover Study to Assess the Relative Bioavailability of Four New Formulations of the CCR9 Receptor Antagonist GSK1605786A (CCX282) in Healthy Male and Female Subjects | Crohn's Disease | Drug: GSK1605786 ChemoCentryx: formulation A;Drug: GSK1605786 GSK: formulation B;Drug: GSK1605786 GSK direct-fill: formulation C;Drug: GSK1605786 GSK modified-process: formulation D;Drug: GSK1605786 GSK tablet: formulation E | GlaxoSmithKline | NULL | Completed | 18 Years | 55 Years | All | 24 | Phase 1 | United States |
| 1649 | NCT00737932 (ClinicalTrials.gov) | May 2010 | 18/8/2008 | Laquinimod Phase IIa Study in Active Crohn's Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease. | Crohn's Disease | Drug: Laquinimod;Other: placebo | Teva Pharmaceutical Industries | NULL | Completed | 18 Years | 75 Years | Both | 180 | Phase 2 | Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom |
| 1650 | EUCTR2006-000720-13-AT (EUCTR) | 07/04/2010 | 03/03/2010 | Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease. | Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn’s disease - TSO vs. placebo in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Suspension containing 250 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 250 Other descriptive name: Suspension containing 250 embryonated, viable TSO/15ml Product Name: Suspension containing 2500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 2500 Other descriptive name: Suspension containing 2500 embryonated, viable TSO/15ml Product Name: Suspension containing 7500 embryonated, viable Trichuris suis ova (TSO)/15ml Product Code: TSO 7500 Other descriptive name: Suspension of 7500 embryonated, viable TSO/15ml | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | Czech Republic;Denmark;Austria;Germany;Switzerland | ||
| 1651 | EUCTR2008-002784-14-GB (EUCTR) | 26/03/2010 | 28/06/2010 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Serbia;Estonia;Hong Kong;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1652 | EUCTR2008-002784-14-SE (EUCTR) | 12/02/2010 | 23/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1653 | NCT00988832 (ClinicalTrials.gov) | February 2010 | 1/10/2009 | An Audit of Patients With Crohn's Disease Treated With Infliximab (P06066) | A UK Retrospective Audit of Patients With Crohn's Disease Treated With Infliximab | Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 380 | N/A | United Kingdom |
| 1654 | NCT01288053 (ClinicalTrials.gov) | January 2010 | 27/1/2011 | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Refractory Crohn's Disease | Crohn's Disease | Biological: Allogeneic Stem Cell Therapy | Northwestern University | NULL | Terminated | 18 Years | 45 Years | All | 9 | Phase 1/Phase 2 | United States |
| 1655 | NCT01053559 (ClinicalTrials.gov) | January 2010 | 19/1/2010 | Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy | Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy | Crohn's Disease | Drug: certolizumab pegol | Shafran Gastroenterology Center | UCB Pharma | Completed | 18 Years | 70 Years | Both | 15 | N/A | United States |
| 1656 | NCT01037322 (ClinicalTrials.gov) | January 2010 | 20/12/2009 | Cannabidiol for Inflammatory Bowel Disease | Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: cannabidiol;Drug: placebo in drops | Meir Medical Center | NULL | Completed | 20 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Israel |
| 1657 | NCT01548014 (ClinicalTrials.gov) | January 2010 | 17/2/2012 | The Effect of a Probiotic Preparation (VSL#3) Plus Infliximab in Children With Crohn's Disease | Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study | Crohn's Disease | Dietary Supplement: VSL#3 | Samsung Medical Center | NULL | Recruiting | 13 Years | 17 Years | Both | 1 | Phase 3 | Korea, Republic of |
| 1658 | NCT01090817 (ClinicalTrials.gov) | January 2010 | 22/3/2010 | An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease | A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease | Crohn Disease | Drug: Mesenchymal stromal cells (MSC) for infusion | R.P.Herrmann | The Queen Elizabeth Hospital;Concord Hospital;Sir Charles Gairdner Hospital;The Alfred | Completed | 18 Years | 55 Years | Both | 21 | Phase 2 | Australia |
| 1659 | NCT01046773 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease | Vitamin D Supplementation as Non-toxic Immunomodulation in Children With Crohn's Disease | Crohn's Disease;Vitamin D Deficiency | Drug: Cholecalciferol | University of California, Los Angeles | The Broad Foundation | Terminated | 8 Years | 18 Years | All | 3 | Phase 1 | United States |
| 1660 | NCT01040910 (ClinicalTrials.gov) | January 2010 | 29/12/2009 | Cannabis for Inflammatory Bowel Disease | A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: smoking of cannabis;Drug: smoking cigarettes with placebo | Meir Medical Center | NULL | Recruiting | 20 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | Israel |
| 1661 | EUCTR2007-006494-90-GB (EUCTR) | 24/12/2009 | 18/06/2009 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;United Kingdom | ||
| 1662 | EUCTR2008-005237-30-NL (EUCTR) | 01/12/2009 | 18/08/2009 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP | Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Other descriptive name: Remsima and Inflectra | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | |||
| 1663 | NCT01024647 (ClinicalTrials.gov) | December 2009 | 2/12/2009 | Optimizing Cimzia in Crohn's Patients | Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy | Crohn's Disease | Biological: certolizumab pegol | Atlanta Gastroenterology Associates | UCB Pharma | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | United States |
| 1664 | EUCTR2008-006957-42-BG (EUCTR) | 17/11/2009 | 21/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania | ||
| 1665 | EUCTR2009-011621-14-AT (EUCTR) | 12/11/2009 | 19/10/2009 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 | A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: Not available Other descriptive name: None | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria | |||
| 1666 | NCT01086553 (ClinicalTrials.gov) | November 2009 | 12/3/2010 | 9 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's Disease | Double-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's Disease | Crohn´s Disease | Drug: budesonide | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 471 | Phase 3 | Germany |
| 1667 | NCT01015391 (ClinicalTrials.gov) | November 2009 | 17/11/2009 | Efficacy Study of T2 Versus AZA to Maintain Clinical and Endoscopic Remission in Postoperative Crohn's Disease | A Randomized, Controlled, Open-label Study to Assess the Efficacy of T2 Versus Azathioprine for the Maintenance of Clinical and Endoscopic Remission in Subjects With Crohn's Disease After Surgical Resection | Crohn's Disease | Drug: T2;Drug: Azathioprine | Jinling Hospital, China | NULL | Recruiting | 18 Years | N/A | Both | 100 | N/A | China |
| 1668 | EUCTR2008-006957-42-DE (EUCTR) | 30/10/2009 | 30/07/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany | ||
| 1669 | EUCTR2009-011220-62-NL (EUCTR) | 26/10/2009 | 13/07/2009 | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study | 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: mesalazine INN or Proposed INN: mesalazine Other descriptive name: AMINOSALICYLIC ACID | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 1670 | EUCTR2008-006957-42-LT (EUCTR) | 19/10/2009 | 12/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania | ||
| 1671 | EUCTR2008-006957-42-SK (EUCTR) | 14/10/2009 | 19/10/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany | ||
| 1672 | NCT00989573 (ClinicalTrials.gov) | October 2009 | 2/10/2009 | A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: OPC-6535 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 18 Years | 64 Years | Both | 191 | Phase 2/Phase 3 | Japan;Korea, Republic of |
| 1673 | NCT01009281 (ClinicalTrials.gov) | October 2009 | 5/11/2009 | An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease | A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Drug: AIN457 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 75 Years | All | 7 | Phase 2 | United States;Austria;Canada;Germany;Poland |
| 1674 | NCT01661257 (ClinicalTrials.gov) | October 2009 | 7/8/2012 | Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy | Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-a Therapy | Crohn's Disease | Drug: Infliximab | Samsung Medical Center | NULL | Completed | 13 Years | 17 Years | Both | 20 | Phase 3 | Korea, Republic of |
| 1675 | EUCTR2008-006957-42-LV (EUCTR) | 25/09/2009 | 08/09/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia | ||
| 1676 | EUCTR2008-006957-42-CZ (EUCTR) | 24/09/2009 | 07/09/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania | ||
| 1677 | EUCTR2008-006957-42-HU (EUCTR) | 16/09/2009 | 04/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania | ||
| 1678 | EUCTR2008-008359-40-DE (EUCTR) | 08/09/2009 | 23/06/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof-of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti IL-17 monoclonal antibody) in patients with moderate to severe active Crohn's disease - A2202 | Moderate to severe Crohn's disease (CDAI >/= 220 and MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Poland;Austria | |||
| 1679 | EUCTR2008-008359-40-PL (EUCTR) | 02/09/2009 | 07/04/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 Other descriptive name: rhumAb to Il-17A (IgG1-k-class) rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Austria;Poland | |||
| 1680 | EUCTR2008-002784-14-DE (EUCTR) | 02/09/2009 | 02/06/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 17.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden;Greece;Spain;Ukraine;Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia | ||
| 1681 | NCT02322008 (ClinicalTrials.gov) | September 2009 | 17/12/2014 | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Biological: infliximab and adalimumab | Regionshospitalet Viborg, Skive | NULL | Completed | 18 Years | N/A | Both | 1035 | N/A | NULL |
| 1682 | EUCTR2008-002783-33-DE (EUCTR) | 24/08/2009 | 23/04/2009 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1116 | Phase 3 | Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Norway;Germany;New Zealand;Sweden | ||
| 1683 | EUCTR2008-002784-14-AT (EUCTR) | 13/08/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1684 | EUCTR2009-013348-35-NL (EUCTR) | 04/08/2009 | 03/07/2009 | (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease | (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease. - Bile acid-FXR-FGF19 functioning in Crohn's disease | Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls. MedDRA version: 9.1;Level: LLT;Classification code 10011400;Term: Crohn's colitis MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10011402;Term: Crohn's disease (colon) | Trade Name: Chenofalk Product Name: Chenofalk Product Code: RVG 07151 INN or Proposed INN: CHENODEOXYCHOLIC ACID Other descriptive name: Chenodiol | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 1685 | NCT01012570 (ClinicalTrials.gov) | August 2009 | 11/11/2009 | The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients | Crohn's Disease | Drug: Application of Adalimumab | Gerhard Rogler | NULL | Terminated | 18 Years | 65 Years | Both | 34 | Switzerland | ||
| 1686 | NCT00367705 (ClinicalTrials.gov) | August 2009 | 22/8/2006 | VSL#3 Treatment in Children With Crohn's Disease | Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease | Crohn's Disease | Dietary Supplement: VSL#3®;Dietary Supplement: Placebo | Hadassah Medical Organization | NULL | Not yet recruiting | 6 Years | 18 Years | Both | 300 | Phase 4 | Israel |
| 1687 | EUCTR2008-007329-38-ES (EUCTR) | 24/07/2009 | 24/04/2009 | Estudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Estudio multicéntrico, aleatorizado, con doble enmascaramiento en grupos paralelos, sobre la dexametasona intraeritrocitaria comparada con un placebo en pacientes con enfermedad de Crohn dependiente de esteroides - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Pacientes con enfermedad de Crohn dependiente de esteroides MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml Product Code: ERY-DEX INN or Proposed INN: fosfato sodico de dexametasona | ERYDEL S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 184 | Spain;Italy | |||
| 1688 | EUCTR2008-002783-33-IT (EUCTR) | 22/07/2009 | 17/03/2009 | Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND | Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn?s Disease - ND | Patients with Moderate to Severe Crohn?s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Vedolizumab Product Code: MLN0002 | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1689 | EUCTR2008-002783-33-GB (EUCTR) | 20/07/2009 | 27/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1690 | EUCTR2008-002783-33-CZ (EUCTR) | 13/07/2009 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1691 | EUCTR2008-005688-32-CZ (EUCTR) | 02/07/2009 | 05/01/2009 | Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region. | Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region. | Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions). MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB | Univeristy Hospital Na Bulovce | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic | ||
| 1692 | NCT00950105 (ClinicalTrials.gov) | July 2009 | 29/7/2009 | Single Ascending Dose Study of Oral CPSI-2364 (Semapimod) | A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Oral CPSI-2364 in Healthy Subjects | Crohn's Disease | Drug: CPSI-2364 or placebo | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | Both | 30 | Phase 1 | United States |
| 1693 | NCT00944736 (ClinicalTrials.gov) | July 2009 | 22/7/2009 | Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease | Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission | Crohn's Disease | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | Children's Mercy Hospital Kansas City | VSL Pharmaceuticals | Completed | 11 Years | 17 Years | Both | 12 | Phase 3 | United States |
| 1694 | NCT00972218 (ClinicalTrials.gov) | July 2009 | 31/8/2009 | Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease | Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease | Spondyloarthritis;Crohn's Disease | Biological: Adalimumab | University of Alberta | Abbott | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | Canada |
| 1695 | EUCTR2008-002783-33-GR (EUCTR) | 18/06/2009 | 05/11/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1696 | EUCTR2009-010163-16-GB (EUCTR) | 05/06/2009 | 18/08/2009 | Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s disease | Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease - Bile salt manipulation in Crohn’s disease | Active Crohn's disease affecting the ileum MedDRA version: 9.1;Level: LLT;Classification code 10011406;Term: Crohn's ileitis MedDRA version: 9.1;Classification code 10058815;Term: Crohn's disease acute episode | Trade Name: Lipitor Trade Name: Cholestagel | University College London | NULL | Not Recruiting | Female: yes Male: yes | 13 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1697 | EUCTR2006-004784-58-GB (EUCTR) | 03/06/2009 | 30/04/2009 | An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study | An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | University of Leuven Hospitals | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 4 | France;Belgium;Germany;United Kingdom | ||
| 1698 | NCT01372969 (ClinicalTrials.gov) | June 2009 | 30/8/2010 | Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease. | Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease. | Crohn's Disease;Anal Fistula | Drug: Cx601 | Tigenix S.A.U. | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1/Phase 2 | Spain |
| 1699 | NCT00851565 (ClinicalTrials.gov) | June 2009 | 24/2/2009 | Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy | Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy | Crohn's Disease | Procedure: Measurement of serum infliximab and anti-infliximab antibodies;Procedure: Treatment according to current standards without knowledge of serum infliximab and anti-infliximab Ab status | Copenhagen University Hospital at Herlev | Aase and Ejnar Danielsens Foundation;Beckett Foundation;the Danish Biotechnology Program;Danish Colitis-Crohn Society;Danish Medical Association Research Fund;Frode V. Nyegaard and wife’s Foundation;Health Science Research Foundation of Region of Copenhagen;Herlev Hospital Research Council;Lundbeck Foundation;P. Carl Petersens Fund;Biomonitor A/S;Prometheus Inc.;The Danish Institute for Health Services Research | Active, not recruiting | 18 Years | N/A | Both | 120 | Phase 4 | Denmark |
| 1700 | NCT00790933 (ClinicalTrials.gov) | May 22, 2009 | 5/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | NULL | Completed | 18 Years | N/A | All | 2243 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic |
| 1701 | EUCTR2008-004919-36-AT (EUCTR) | 20/05/2009 | 10/11/2008 | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: ABT-874 Product Code: ABT-874 Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0 | Abbott | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Denmark;Austria;Sweden | ||
| 1702 | EUCTR2008-008359-40-AT (EUCTR) | 07/05/2009 | 31/03/2009 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | A multicenter, randomised, double-blind, placebo-controlled, parallel-group proof- of-concept study to assess the efficacy, safety and tolerability of two single i.v. infusions of AIN457 10 mg/kg (anti-IL17 monoclonal antibody) in patients with moderate to severe active Crohn’s disease - A2202 | Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany;Poland;Austria | |||
| 1703 | NCT00889161 (ClinicalTrials.gov) | May 2009 | 24/4/2009 | Curcumin in Pediatric Inflammatory Bowel Disease | Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Curcumin | Seattle Children's Hospital | NULL | Completed | 8 Years | 18 Years | Both | 11 | Phase 1 | United States |
| 1704 | NCT00742781 (ClinicalTrials.gov) | May 2009 | 26/8/2008 | Vitamin D Supplementation in Crohn's Patients | Vitamin D and Crohn's Disease From the Bench to the Clinic | Inflammatory Bowel Disease | Dietary Supplement: Vitamin D | Penn State University | NULL | Completed | 18 Years | 70 Years | All | 21 | Phase 1 | United States |
| 1705 | EUCTR2008-002784-14-EE (EUCTR) | 28/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia | ||
| 1706 | EUCTR2008-001137-99-GB (EUCTR) | 28/04/2009 | 27/11/2008 | CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease | CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Ciprofloxacin Product Code: PL 20532/0012 INN or Proposed INN: Ciprofloxacin hydrochloride Product Name: Budesonide Product Code: PL 17901/0122 INN or Proposed INN: Budesonide Other descriptive name: Entocort CR Trade Name: DOXYCYCLINE Product Name: DOXYCYCLINE INN or Proposed INN: DOXYCYCLINE HYCLATE Other descriptive name: DOXYCYCLINE Trade Name: HYDROXYCHLOROQUINE Product Name: HYDROXYCHLOROQUINE SULPHATE INN or Proposed INN: HYDROXYCHLOROQUINE SULPHATE Other descriptive name: PLAQUENIL | Royal Liverpool & Broadgreen University Hospitals Trust | University of Liverpool | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1707 | EUCTR2008-002784-14-BE (EUCTR) | 21/04/2009 | 14/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1708 | EUCTR2008-002784-14-HU (EUCTR) | 20/04/2009 | 27/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1709 | EUCTR2008-002783-33-SE (EUCTR) | 15/04/2009 | 22/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1710 | EUCTR2008-002783-33-HU (EUCTR) | 14/04/2009 | 27/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1711 | NCT00899678 (ClinicalTrials.gov) | April 2009 | 29/4/2009 | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents | A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) | Crohn's Disease | Drug: Certolizumab Pegol | UCB Celltech | NULL | Terminated | 6 Years | 17 Years | All | 99 | Phase 2 | United States;Australia;Canada;New Zealand |
| 1712 | NCT01277289 (ClinicalTrials.gov) | April 2009 | 5/1/2011 | Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease | Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease | Crohn's Disease | Drug: Dexamethasone | Erydel | NULL | Terminated | 18 Years | 80 Years | Both | 51 | Phase 3 | Italy;Romania;Spain |
| 1713 | NCT00862121 (ClinicalTrials.gov) | April 2009 | 13/3/2009 | A Study With Pentasa in Patients With Active Crohn's Disease | PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo. | Crohn´s Disease | Drug: Pentasa;Drug: Placebo | Ferring Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 20 | Phase 3 | United States;Belgium;Denmark;France;Germany;Sweden;United Kingdom;Spain |
| 1714 | EUCTR2009-009926-94-DK (EUCTR) | 26/03/2009 | 25/02/2009 | Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy | Use of combined measurements of serum infliximab and anti-infliximab antibodies in the treatment of patients with Crohns disease failing infliximab therapy | Patients with Crohns diseases failing treatment with infliximab MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade Trade Name: Humira | Department of medical gastroenterology, Herlev Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 1715 | EUCTR2008-002783-33-FR (EUCTR) | 23/03/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1716 | EUCTR2008-004919-36-SE (EUCTR) | 11/03/2009 | 11/12/2008 | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: ABT-874 Product Code: ABT-874 INN or Proposed INN: None Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0 | Abbott | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Denmark;Austria;Sweden | ||
| 1717 | EUCTR2008-000649-77-DE (EUCTR) | 11/03/2009 | 26/09/2008 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria | ||
| 1718 | EUCTR2008-002783-33-PT (EUCTR) | 06/03/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1719 | NCT00820365 (ClinicalTrials.gov) | March 2009 | 9/1/2009 | SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease | Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) | Inflammatory Bowel Disease (IBD) | Drug: SC12267 (4SC-101) | 4SC AG | NULL | Completed | 18 Years | 70 Years | Both | 34 | Phase 2 | Bulgaria;Germany;Romania |
| 1720 | EUCTR2007-005455-42-NL (EUCTR) | 26/02/2009 | 18/09/2008 | ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL | ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL | Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction. MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Budenofalk Product Name: Budenofalk INN or Proposed INN: BUDESONIDE Trade Name: Kenacort Product Name: Kenacort INN or Proposed INN: TRIAMCINOLONE | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 42 | Netherlands | |||
| 1721 | EUCTR2008-002784-14-CZ (EUCTR) | 20/02/2009 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1722 | EUCTR2008-002783-33-NL (EUCTR) | 18/02/2009 | 05/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland;Sweden | ||
| 1723 | EUCTR2008-003571-45-GB (EUCTR) | 18/02/2009 | 16/07/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Limited, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 1724 | EUCTR2008-002784-14-NL (EUCTR) | 18/02/2009 | 05/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 19.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1725 | EUCTR2008-000649-77-FR (EUCTR) | 16/02/2009 | 07/12/2009 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | France;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom | ||
| 1726 | EUCTR2007-006494-90-CZ (EUCTR) | 11/02/2009 | 07/11/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Canada;Belgium;Poland;United Kingdom | ||
| 1727 | EUCTR2008-007329-38-IT (EUCTR) | 06/02/2009 | 21/01/2009 | Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn?s disease - Intra-erythrocyte dexamethasone in patients with steroid-dependent Crohn?s Disease | Patients with steroid-dependent Crohn?s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml Product Code: ERY-DEX INN or Proposed INN: dexamethasone sodium phosphate | ERYDEL S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 184 | Spain;Italy | |||
| 1728 | EUCTR2008-000649-77-NL (EUCTR) | 06/02/2009 | 12/09/2008 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria | ||
| 1729 | EUCTR2008-002783-33-BE (EUCTR) | 05/02/2009 | 14/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1730 | NCT00245505 (ClinicalTrials.gov) | February 2009 | 26/10/2005 | The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active Drug: Crohn's Disease | The Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot Study | Crohn's Disease | Drug: Mesalazine (Mesalamine) | Ferring Pharmaceuticals | NULL | Terminated | 18 Years | 70 Years | Both | 3 | Phase 3 | Sweden |
| 1731 | EUCTR2006-005526-23-GB (EUCTR) | 29/01/2009 | 27/04/2009 | Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's disease | Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2 - Plantain NSP in Crohn's disease | Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Plantain NSP Product Code: NSP001 | Provexis Plc | NULL | Not Recruiting | Female: yes Male: yes | 76 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1732 | EUCTR2008-002783-33-AT (EUCTR) | 29/01/2009 | 28/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 1733 | EUCTR2008-002783-33-MT (EUCTR) | 28/01/2009 | 25/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece | ||
| 1734 | EUCTR2008-002100-26-BE (EUCTR) | 28/01/2009 | 31/07/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 1735 | EUCTR2008-002784-14-IS (EUCTR) | 27/01/2009 | 06/11/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients WithUlcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1508 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden | ||
| 1736 | EUCTR2008-000649-77-ES (EUCTR) | 27/01/2009 | 29/10/2008 | Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI | Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI | Enfermedad de Crohn activa de moderada a grave MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | France;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 1737 | EUCTR2008-004919-36-DK (EUCTR) | 23/01/2009 | 18/12/2008 | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: ABT-874 Product Code: ABT-874 INN or Proposed INN: None Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0 | Abbott | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Denmark;Austria;Sweden | ||
| 1738 | EUCTR2008-000649-77-GB (EUCTR) | 23/01/2009 | 03/10/2008 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Austria | ||
| 1739 | EUCTR2008-003571-45-CZ (EUCTR) | 20/01/2009 | 20/01/2009 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy | |||
| 1740 | EUCTR2008-004919-36-BE (EUCTR) | 20/01/2009 | 14/11/2008 | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: ABT-874 Product Code: ABT-874 INN or Proposed INN: None Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0 | Abbott | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | Belgium;Denmark;Austria;Sweden | ||
| 1741 | EUCTR2008-002784-14-BG (EUCTR) | 16/01/2009 | 12/01/2009 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1742 | EUCTR2006-004814-41-GB (EUCTR) | 16/01/2009 | 07/03/2008 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled pen INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | |||
| 1743 | EUCTR2008-002783-33-BG (EUCTR) | 16/01/2009 | 13/01/2009 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1744 | EUCTR2008-002100-26-FR (EUCTR) | 16/01/2009 | 02/09/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 1745 | EUCTR2008-002783-33-SK (EUCTR) | 15/01/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1746 | EUCTR2008-002784-14-SK (EUCTR) | 15/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 18.1;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1747 | EUCTR2008-002783-33-IS (EUCTR) | 13/01/2009 | 06/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands;Sweden | ||
| 1748 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1749 | EUCTR2008-002783-33-EE (EUCTR) | 09/01/2009 | 27/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1750 | EUCTR2008-002783-33-IE (EUCTR) | 09/01/2009 | 28/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1751 | EUCTR2008-002784-14-IE (EUCTR) | 09/01/2009 | 28/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden | ||
| 1752 | EUCTR2008-002100-26-GB (EUCTR) | 07/01/2009 | 19/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Denmark;Belgium;France;Sweden | |||
| 1753 | EUCTR2008-000649-77-BE (EUCTR) | 05/01/2009 | 20/10/2008 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria | ||
| 1754 | NCT01429922 (ClinicalTrials.gov) | January 2009 | 29/8/2011 | Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose | Double Blind Placebo-controlled,Safety and Tolerability of ZP1848 Administered as Ascending Single Dose SUBCUTANEOUS Bolus Injections in Healthy Subjects Followed by Multiple Dose Cohort of Patients With Stable Crohn's Disease in Remission | Crohns Disease | Drug: ZP1848 | MDS Pharma Services | NULL | Completed | 18 Years | 50 Years | Both | 60 | Phase 1/Phase 2 | United States |
| 1755 | NCT00844285 (ClinicalTrials.gov) | January 2009 | 13/2/2009 | SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry | A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease | Crohn's Disease | Drug: Cimzia | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 3045 | United States | |
| 1756 | EUCTR2008-002784-14-LV (EUCTR) | 19/12/2008 | 31/10/2008 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Takeda Development Centre Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand;Sweden | ||
| 1757 | EUCTR2008-002783-33-LV (EUCTR) | 19/12/2008 | 31/10/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1758 | EUCTR2008-002783-33-DK (EUCTR) | 18/12/2008 | 07/11/2008 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Crohn’s Disease | Moderate to Severe Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: VEDOLIZUMAB Product Code: MLN0002 INN or Proposed INN: VEDOLIZUMAB | Millennium Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1060 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland;Sweden | ||
| 1759 | EUCTR2008-004276-49-FR (EUCTR) | 18/12/2008 | 21/07/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | France;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 1760 | EUCTR2007-002716-26-EE (EUCTR) | 17/12/2008 | 11/12/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1761 | EUCTR2008-003571-45-NL (EUCTR) | 17/12/2008 | 25/11/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 1762 | EUCTR2004-002163-24-GB (EUCTR) | 08/12/2008 | 17/02/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 1763 | NCT01378390 (ClinicalTrials.gov) | December 2008 | 21/6/2011 | Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease | Randomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease | Complex Perianal Fistula;Crohn Disease | Drug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: Placebo | Tigenix S.A.U. | NULL | Terminated | 18 Years | N/A | All | 56 | Phase 3 | Austria;Netherlands;Spain |
| 1764 | NCT00801125 (ClinicalTrials.gov) | December 2008 | 1/12/2008 | Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | NULL |
| 1765 | NCT00783692 (ClinicalTrials.gov) | December 2008 | 31/10/2008 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 1116 | Phase 3 | United States;Canada;Puerto Rico |
| 1766 | NCT00771667 (ClinicalTrials.gov) | December 2008 | 10/10/2008 | A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy | Crohn's Disease | Drug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) | Centocor, Inc. | NULL | Completed | 18 Years | N/A | All | 526 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom |
| 1767 | NCT00805766 (ClinicalTrials.gov) | December 2008 | 9/12/2008 | Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD) | Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD) | Crohn's Disease | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 16 Years | 75 Years | All | 39 | Phase 3 | Japan |
| 1768 | EUCTR2008-002100-26-SE (EUCTR) | 27/11/2008 | 08/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Denmark;Belgium;France;Sweden | |||
| 1769 | EUCTR2007-006494-90-BE (EUCTR) | 24/11/2008 | 18/08/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbvie Deutschland GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Belgium;United States;Czech Republic;Canada;Poland | ||
| 1770 | EUCTR2008-003571-45-FR (EUCTR) | 21/11/2008 | 07/08/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 1771 | EUCTR2008-000649-77-AT (EUCTR) | 20/11/2008 | 03/11/2008 | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI | Moderately to Severely Active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody Product Name: Ustekinumab Product Code: CNTO 1275 INN or Proposed INN: Ustekinumab Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria | ||
| 1772 | EUCTR2008-002100-26-DE (EUCTR) | 19/11/2008 | 06/03/2009 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | France;Belgium;Denmark;Germany;United Kingdom;Sweden | |||
| 1773 | EUCTR2008-003571-45-IT (EUCTR) | 18/11/2008 | 22/09/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE - ND | CP-690,550 is being developed for the treatment of patients with moderate-to-severe Crohn?s disease, as defined by a baseline Crohn?s Disease Activity Index (CDAI) score of 220 to 450 inclusive. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Code: CP-690,550 Product Name: CP-690,550 Product Code: CP-690,550 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 1774 | EUCTR2008-004276-49-GB (EUCTR) | 12/11/2008 | 27/01/2009 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 1775 | EUCTR2008-003571-45-BE (EUCTR) | 05/11/2008 | 14/07/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 1776 | EUCTR2008-002100-26-DK (EUCTR) | 04/11/2008 | 18/08/2008 | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo - PEACE | Active mild to moderate crohn's disease. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: PENTASA Sachet INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid | Ferring Pharmaceuticals A/S | NULL | Not Recruiting | Female: yes Male: yes | 510 | Germany;United Kingdom;Belgium;Denmark;France;Sweden | |||
| 1777 | NCT00603616 (ClinicalTrials.gov) | November 2008 | 16/1/2008 | Induction of Clinical Response Using Rifaximin in Crohn's Disease | A Randomized, Prospective, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of Rifaximin for the Treatment of Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Placebo Comparator;Drug: Rifaximin | Scott Lee | Bausch Health Americas, Inc. | Completed | 18 Years | 80 Years | All | 36 | Phase 2 | United States |
| 1778 | NCT00752622 (ClinicalTrials.gov) | November 2008 | 12/9/2008 | Treatment With Infliximab in a Medical Setting (Study P05587) | Optimization of Treatment With Infliximab in a Medical Setting | Crohn's Disease | Biological: Infliximab 5 mg/kg;Biological: Infliximab 5 mg/kg every 6 weeks;Biological: Infliximab 7 mg/kg every 8 weeks | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 100 | Phase 4 | Canada |
| 1779 | EUCTR2008-003571-45-HU (EUCTR) | 29/10/2008 | 05/08/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Hungary;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Italy | |||
| 1780 | EUCTR2006-003371-13-CZ (EUCTR) | 29/10/2008 | 11/05/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1781 | EUCTR2008-003571-45-ES (EUCTR) | 15/10/2008 | 01/08/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASEESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVE | Enfermedad de Crohn MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer S.A | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 1782 | EUCTR2008-004276-49-NL (EUCTR) | 14/10/2008 | 05/08/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||
| 1783 | EUCTR2008-003571-45-SK (EUCTR) | 13/10/2008 | 23/09/2008 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLELGROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY ANDEFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERECROHN’S DISEASE | CROHN’S DISEASE MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CP-690,550 Product Name: CP-690,550 | Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 2 | France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Netherlands;Italy;United Kingdom | ||
| 1784 | EUCTR2008-004276-49-BE (EUCTR) | 07/10/2008 | 15/09/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease | Moderate to severe Crohn's disease (CD) MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Capsules 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Netherlands;United Kingdom;Italy | ||
| 1785 | NCT00810030 (ClinicalTrials.gov) | October 2008 | 16/12/2008 | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR | Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative Colitis | Drug: Ferric carboxymaltose;Drug: Iron Sucrose | Vifor Inc. | Parexel;ClinStar | Completed | 18 Years | N/A | Both | 484 | Phase 3 | Austria;Russian Federation |
| 1786 | NCT00791557 (ClinicalTrials.gov) | October 2008 | 13/11/2008 | Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease | An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum | Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Infliximab | University Hospitals Cleveland Medical Center | Centocor, Inc. | Completed | 18 Years | 75 Years | All | 2 | N/A | United States |
| 1787 | NCT00808262 (ClinicalTrials.gov) | October 2008 | 12/12/2008 | Safety and Immunogenicity of a TNFa Kinoid in Patients With Crohn's Disease | A Phase I/II, Open-label, Escalating Dose, Optimal Two-stage, Study of TNFa-Kinoid (TNF- K) Immunization in Crohn's Disease Patients | Crohn's Disease | Biological: TNFa Kinoid | Neovacs | NULL | Completed | 18 Years | 65 Years | Both | 21 | Phase 1/Phase 2 | South Africa;Switzerland |
| 1788 | EUCTR2008-003167-39-BE (EUCTR) | 17/09/2008 | 28/08/2008 | Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. | Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. | Crohn' disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: diflucan INN or Proposed INN: FLUCONAZOLE | Cliniques Universitaires Saint Luc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Belgium | |||
| 1789 | EUCTR2008-004276-49-ES (EUCTR) | 16/09/2008 | 18/07/2008 | Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. | Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. | Enfermedad de Crohn activa de moderada a grave MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Laquinimod Cápsulas 0.5 mg Product Code: TV-5600 INN or Proposed INN: laquinimod Other descriptive name: ABR-215062 sodium salt | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | France;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 1790 | EUCTR2007-001913-41-AT (EUCTR) | 10/09/2008 | 18/06/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1791 | EUCTR2008-004276-49-IT (EUCTR) | 08/09/2008 | 04/08/2008 | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn?s Disease - ND | A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn?s Disease - ND | Crohn Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns | Product Name: Laquinimod Product Code: TV-5600 INN or Proposed INN: Laquinimod | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||
| 1792 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1793 | NCT00731172 (ClinicalTrials.gov) | September 2008 | 6/8/2008 | A Double Blind Placebo Control Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Crohn's Disease | A Pilot Single Center,Randomized,Double Blind Placebo Controlled Study to Assess the Safety,Tolerability and Efficacy of Copaxone in Inducing Remission in Patients With Moderately Active Crohn's Disease. | Crohns Disease | Drug: glatiramer acetate;Drug: placebo | Tel-Aviv Sourasky Medical Center | Teva Pharmaceutical Industries;Given Imaging Ltd. | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 2 | Israel |
| 1794 | NCT00736983 (ClinicalTrials.gov) | September 2008 | 15/8/2008 | Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's | Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin | Crohn's Disease With Perianal Fistulas | Drug: adalimumab;Drug: ciprofloxacin | Foundation for Liver Research | NULL | Completed | 18 Years | 70 Years | Both | 76 | Phase 3 | Netherlands |
| 1795 | EUCTR2007-001913-41-DE (EUCTR) | 27/08/2008 | 20/03/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1796 | EUCTR2007-002716-26-AT (EUCTR) | 08/08/2008 | 18/06/2008 | Clinical study to assess the long term safety of certolizumab pegol, administered at weeks 0, 2 and 4 and every 4 weeks thereafter, in patients with Crohn's disease and who participated in a previous study encoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Australia;Latvia;Germany;New Zealand | ||
| 1797 | NCT00720538 (ClinicalTrials.gov) | August 2008 | 18/7/2008 | Thalidomide in Pediatric Inflammatory Bowel Diseases. | Randomized Controlled Double-blind Vs. Placebo Multicentre Study on the Safety and Effectiveness of Thalidomide in the Treatment of Refractory Crohn's Disease and Ulcerative Colitis. | Inflammatory Bowel Diseases;Crohn's Disease;Ulcerative Colitis | Drug: Thalidomide;Drug: placebo | IRCCS Burlo Garofolo | Ospedale Meyer;Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.;Vittore Buzzi Children's Hospital;University of Pisa;Pediatric Gastroenterology Unit, University of Messina.;Università degli Studi di Brescia;University of Trieste | Completed | 2 Years | 18 Years | Both | 84 | Phase 3 | Italy |
| 1798 | NCT00584740 (ClinicalTrials.gov) | August 2008 | 21/12/2007 | Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single iv Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Active Crohn's Disease | Crohn's Disease | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 75 Years | All | 59 | Phase 2 | Germany;Canada;United States |
| 1799 | EUCTR2006-004814-41-NL (EUCTR) | 24/07/2008 | 22/01/2008 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 1800 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1801 | EUCTR2006-004784-58-FR (EUCTR) | 07/07/2008 | 24/06/2008 | An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease. | An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease. | Crohn's disease | Trade Name: Selective Immunosuppressive agents Product Name: Remicade 100 mg INN or Proposed INN: infliximab | CHRU de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | United Kingdom;Germany;Belgium;France | |||
| 1802 | NCT01235325 (ClinicalTrials.gov) | July 2008 | 4/11/2010 | The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients | The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease | Supplementation;Bone Health;Crohn's Disease | Dietary Supplement: phylloquinone (vitamin K1);Dietary Supplement: placebo | University College Cork | Health Research Board, Ireland | Completed | 18 Years | 70 Years | Both | 70 | Phase 4 | Ireland |
| 1803 | NCT02997059 (ClinicalTrials.gov) | July 2008 | 14/12/2016 | Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease. | Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus Placebo | Crohn's Disease Aggravated | Drug: Fluconazole;Other: Placebo | University Hospital, Lille | Ministry of Health, France | Terminated | 18 Years | N/A | Both | 35 | Phase 2 | France |
| 1804 | NCT00715117 (ClinicalTrials.gov) | July 2008 | 14/7/2008 | The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease | The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease | Crohn's Disease | Drug: Naltrexone;Other: Placebo, sugar pill | Milton S. Hershey Medical Center | NULL | Completed | 6 Years | 17 Years | All | 14 | Phase 2 | United States |
| 1805 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1806 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 1807 | EUCTR2007-000189-19-IT (EUCTR) | 10/06/2008 | 17/10/2008 | Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23 | Multicenter, randomized, double-blind, placebo-controlled, study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn?s Disease - DSC/06/2357/23 | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: ITF 2357 | ITALFARMACO | NULL | Not Recruiting | Female: yes Male: yes | 80 | Netherlands;Belgium;Italy | |||
| 1808 | NCT00707512 (ClinicalTrials.gov) | June 2008 | 27/6/2008 | CD INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | INFORM: Investigating Natalizumab Through Further Observational Research and Monitoring | Crohn's Disease | Drug: natalizumab | Biogen | NULL | Terminated | 18 Years | N/A | Both | 87 | N/A | United States;Puerto Rico |
| 1809 | EUCTR2006-004784-58-DE (EUCTR) | 27/05/2008 | 11/03/2008 | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: remicade Product Name: remicade INN or Proposed INN: INFLIXIMAB | University of Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | United Kingdom;Germany;Belgium;France | |||
| 1810 | EUCTR2006-004814-41-IT (EUCTR) | 19/05/2008 | 13/03/2008 | A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND | A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND | Moderate to severe Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA INN or Proposed INN: Adalimumab Trade Name: HUMIRA INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 1811 | EUCTR2008-001131-35-NL (EUCTR) | 14/05/2008 | 29/05/2008 | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial | this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months | Trade Name: Remicade Product Name: Infliximab Product Code: EU/1/99/116/003 Trade Name: Imuran Product Name: Azathioprine Product Code: RVG 05565 | Academic Medical Center, department of Gastroenterology and hepatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 1812 | NCT00686374 (ClinicalTrials.gov) | May 1, 2008 | 27/5/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's Disease | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 7 Years | 18 Years | All | 100 | Phase 3 | Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States |
| 1813 | NCT00672763 (ClinicalTrials.gov) | May 2008 | 2/5/2008 | Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (The IBDVit Study): Double-Blind, Placebo-Controlled Trial of Adjuvant Vitamin D (Colecalciferol) With Corticosteroids in Active Crohn's Disease | Crohn's Disease | Drug: Colecalciferol D3 (Vigantol Oil);Drug: Medium chain triglycerides | Imperial College London | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United Kingdom |
| 1814 | NCT00609973 (ClinicalTrials.gov) | May 2008 | 24/1/2008 | Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease | Double-blind, Placebo Controlled, Randomized, Multicentre, Pilot Study on the Safety and Efficacy of Ciprofloxacin for Prophylactic Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease Patients | Crohn's Disease | Drug: Ciprofloxacin;Drug: Placebo | University of North Carolina, Chapel Hill | Crohn's and Colitis Foundation;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 70 Years | All | 33 | Phase 2 | United States |
| 1815 | NCT00552344 (ClinicalTrials.gov) | May 2008 | 31/10/2007 | A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease | A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085 | Crohn Disease | Biological: Cimzia | UCB BIOSCIENCES GmbH | PPD | Completed | 18 Years | 75 Years | All | 403 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Chile;Czech Republic;Finland |
| 1816 | NCT01297907 (ClinicalTrials.gov) | May 2008 | 24/1/2011 | Bronchial Hyperreactivity in Children With Crohn Disease | Crohn's Disease | Other: Methacholine Challenge Test;Other: Fractional Exhaled NO (FENO);Other: Blood Test;Other: PCDAI | Rambam Health Care Campus | NULL | Completed | 6 Years | 25 Years | Both | 47 | N/A | Israel | |
| 1817 | EUCTR2008-001467-10-GB (EUCTR) | 30/04/2008 | 28/03/2008 | Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3 | Ulcerative colitis - in remissionCrohn's Disease - in remission MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom | ||||
| 1818 | EUCTR2008-001466-93-GB (EUCTR) | 30/04/2008 | 28/03/2008 | Trial of adjuvant vitamin D with Infliximab in active Crohn's Disease (IBDVit2). - IBDVit2 | Active Crohn's Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom | ||||
| 1819 | EUCTR2007-001913-41-CZ (EUCTR) | 14/04/2008 | 07/04/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1820 | EUCTR2007-006692-37-GB (EUCTR) | 10/04/2008 | 25/01/2008 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM | Imperial College London | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1821 | EUCTR2007-002716-26-CZ (EUCTR) | 07/04/2008 | 07/04/2008 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Estonia;Hungary;Czech Republic;Finland;Belgium;Austria;Latvia;Italy | ||
| 1822 | EUCTR2006-003371-13-IE (EUCTR) | 03/04/2008 | 05/02/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1823 | EUCTR2006-004814-41-CZ (EUCTR) | 12/03/2008 | 01/06/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 1824 | EUCTR2007-002716-26-IT (EUCTR) | 04/03/2008 | 12/02/2008 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn?s disease who have participated in study C87085 - ND | Crohn?s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1825 | EUCTR2007-001913-41-IT (EUCTR) | 04/03/2008 | 12/02/2008 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn?s disease - ND | Crohn?s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celletech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1826 | NCT00552058 (ClinicalTrials.gov) | March 2008 | 18/10/2007 | Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease | Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease. | Crohn Disease | Biological: certolizumab pegol (CDP870, CZP);Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | 75 Years | All | 439 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Czechia;Estonia;Finland;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Czech Republic;Spain |
| 1827 | NCT01487759 (ClinicalTrials.gov) | March 2008 | 6/12/2011 | Prebiotic Effect on Metabolites in Crohn's Disease | Metabolite Profiling of the Impact of Oligofructose Enriched Inulin in Crohn's Disease Patients | Crohn Disease | Dietary Supplement: Oligofructose enriched inulin;Dietary Supplement: Maltodextrin | Katholieke Universiteit Leuven | NULL | Completed | 18 Years | N/A | Both | 67 | N/A | Belgium |
| 1828 | EUCTR2007-004269-16-GB (EUCTR) | 28/02/2008 | 26/03/2008 | Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children | Pharmacokinetic studies of recombinant human insulin-like growth factor I (rhIGF-I) in children with Crohn’s disease-induced growth retardation. - IGF-I in growth-retarded Crohn's disease children | Growth failure in children with Crohn's disease | Trade Name: Increlex Product Name: Increlex 10mg/ml solution for injection | Queen Mary, University of London | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 1829 | EUCTR2006-003371-13-PL (EUCTR) | 27/02/2008 | 30/11/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02. | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02. | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1830 | EUCTR2007-001913-41-EE (EUCTR) | 11/02/2008 | 11/12/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1831 | EUCTR2007-003239-21-FR (EUCTR) | 05/02/2008 | 15/01/2008 | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home - PERFECT | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Certolizumab pegol Product Code: CDP870 INN or Proposed INN: Certolizumab pegol (rINN) Other descriptive name: Anti TNF humanized antibody Fab fragment-PEG conjugate | UCB PHARMA S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | France | |||
| 1832 | NCT00609752 (ClinicalTrials.gov) | February 2008 | 24/1/2008 | Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease | Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease | Crohn Disease | Drug: prednisolone;Dietary Supplement: Alicalm (polymeric liquid formula) | University Hospital Birmingham | SHS International;Children's Memorial Research Foundation;St George's University Hospital Research Foundation | Recruiting | 7 Years | 17 Years | Both | 80 | Phase 4 | United Kingdom |
| 1833 | EUCTR2007-001913-41-BE (EUCTR) | 23/01/2008 | 13/11/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1834 | EUCTR2007-002716-26-BE (EUCTR) | 22/01/2008 | 16/10/2007 | Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. | Crohn's disease MedDRA version: 16.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Romania;Australia;Latvia;Germany;New Zealand | ||
| 1835 | EUCTR2006-004814-41-BE (EUCTR) | 21/01/2008 | 01/06/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 1836 | EUCTR2007-001014-17-DE (EUCTR) | 07/01/2008 | 03/03/2008 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy | ||
| 1837 | NCT00615199 (ClinicalTrials.gov) | January 2008 | 14/1/2008 | A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease. | Crohn's Disease | Drug: CP-690,550;Drug: Placebo | Pfizer | NULL | Completed | 18 Years | N/A | All | 139 | Phase 2 | United States;Belgium;Czech Republic;France;Hungary;Italy;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom |
| 1838 | NCT02185183 (ClinicalTrials.gov) | January 2008 | 28/4/2014 | Oral Administration of AlequelTM for Patients With Inflammatory Bowel Disease (IBD) | Phase 2 Clinical Trial for Oral Administration of Alequel for Patients With IBD | Crohn's Disease | Drug: Alequel | Hadassah Medical Organization | NULL | Completed | 18 Years | 70 Years | All | 22 | Phase 1/Phase 2 | NULL |
| 1839 | NCT00621257 (ClinicalTrials.gov) | January 2008 | 11/2/2008 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Terminated | 5 Years | 21 Years | All | 134 | N/A | United States |
| 1840 | EUCTR2007-001913-41-LV (EUCTR) | 20/12/2007 | 05/11/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1841 | EUCTR2007-002716-26-LV (EUCTR) | 20/12/2007 | 05/11/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Czech Republic;Estonia;Hungary;Finland;Belgium;Austria;Latvia;Italy | ||
| 1842 | EUCTR2007-002716-26-HU (EUCTR) | 18/12/2007 | 31/10/2007 | Clinical study to assess the long term safety of certolizumab pegol,administered at weeks 0, 2 and 4 and every 4 weeks thereafter, inpatients with Crohn's disease and who participated in a previous studyencoded C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti TNF alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085. | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Australia;Latvia;Germany;New Zealand;United States;Estonia;Finland;Ukraine;Austria;Israel;Russian Federation;Chile;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania | ||
| 1843 | EUCTR2007-001913-41-HU (EUCTR) | 18/12/2007 | 31/10/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease. | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Finland;Hungary;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1844 | EUCTR2007-002716-26-FI (EUCTR) | 12/12/2007 | 16/10/2007 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | A phase IIIb, multinational, open-label, follow-on trial to C87085 designed to assess the long-term safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered at weeks 0, 2 and 4, and then every 4 weeks thereafter, in subjects with moderately to severely active Crohn’s disease who have participated in study C87085 | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Hungary;Finland;Czech Republic;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1845 | EUCTR2007-001913-41-FI (EUCTR) | 12/12/2007 | 16/10/2007 | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease | Crohn`s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 550 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Belgium;Estonia;Italy;Latvia;Austria | ||
| 1846 | NCT00619489 (ClinicalTrials.gov) | December 2007 | 11/2/2008 | Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: vedolizumab | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 72 | Phase 2 | Canada |
| 1847 | NCT00562887 (ClinicalTrials.gov) | November 2007 | 21/11/2007 | Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease | A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease. | Crohn's Disease | Biological: Placebo;Biological: ABT-874 | Abbott | NULL | Terminated | 18 Years | 74 Years | Both | 246 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Denmark;Puerto Rico;Germany |
| 1848 | NCT00358683 (ClinicalTrials.gov) | November 2007 | 28/7/2006 | A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease | Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study. | Crohn's Disease | Drug: Certolizumab pegol | UCB Pharma | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 1849 | EUCTR2007-001014-17-HU (EUCTR) | 16/10/2007 | 19/06/2007 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR INN or Proposed INN: Rifaximin | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy | ||
| 1850 | NCT00774969 (ClinicalTrials.gov) | October 2007 | 16/10/2008 | Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease | Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease | Perianal Crohns' | Drug: Metronidazole | S.L.A. Pharma AG | NULL | Completed | 18 Years | 65 Years | Both | 19 | Phase 1 | United Kingdom |
| 1851 | NCT00792740 (ClinicalTrials.gov) | October 2007 | 14/11/2008 | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease | Crohn's Disease | Drug: ITF2357;Drug: Placebo capsules | Italfarmaco | NULL | Terminated | 18 Years | 88 Years | Both | 51 | Phase 1/Phase 2 | Belgium |
| 1852 | NCT00543374 (ClinicalTrials.gov) | September 17, 2007 | 11/10/2007 | Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease | A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: Placebo;Drug: PROCHYMAL adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 98 | Phase 3 | United States;Canada |
| 1853 | EUCTR2006-005800-15-GB (EUCTR) | 17/09/2007 | 01/08/2007 | Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection | Randomised controlled trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgical resection - TOPPIC | Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 6-Mercaptopurine (Puri-Nethol) Product Name: 6-Mercaptopurine (Puri-nethol) | University of Edinburgh | NHS Lothian | Not Recruiting | Female: yes Male: yes | 234 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1854 | NCT00482092 (ClinicalTrials.gov) | September 17, 2007 | 30/5/2007 | Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease | A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease | Crohn's Disease | Drug: Prochymal®;Drug: Placebo | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 330 | Phase 3 | United States;Australia;Canada;New Zealand |
| 1855 | NCT00528073 (ClinicalTrials.gov) | September 2007 | 10/9/2007 | Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease | A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease | Crohn's Disease | Drug: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Completed | 18 Years | 75 Years | Both | 410 | Phase 2 | France;Germany;Hungary;Israel;Italy;Poland;Russian Federation |
| 1856 | EUCTR2006-003371-13-GB (EUCTR) | 16/08/2007 | 22/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 02 incorporating Amendments 02 (Version 1.0, Date: 06-Dec-2006) and 03 (Version 1.0, Date: 05-Mar-2007).+ Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Pharmacogenetics Blood Sample Protocol Amendment 01 - Site Specific (version 2.0, Date 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1857 | EUCTR2007-000189-19-BE (EUCTR) | 16/08/2007 | 03/08/2007 | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Code: ITF2357 | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Netherlands;Belgium;Italy | |||
| 1858 | EUCTR2006-004814-41-FR (EUCTR) | 07/08/2007 | 21/05/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 3 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | ||
| 1859 | EUCTR2007-000189-19-NL (EUCTR) | 06/08/2007 | 14/06/2007 | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of ITF2357 on mucosal healing in patients with moderate-to-severe active Crohn’s Disease | Moderate-to-severe active Crohn’s Disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Code: ITF2357 | Italfarmaco S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Netherlands;Belgium;Italy | |||
| 1860 | NCT00511329 (ClinicalTrials.gov) | August 2007 | 2/8/2007 | Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease | Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease | Arthritis, Juvenile Rheumatoid;Crohn Disease | Drug: somatropin [rDNA origin] for injection | Nationwide Children's Hospital | Pfizer | Terminated | 5 Years | 17 Years | All | 10 | Phase 2/Phase 3 | United States |
| 1861 | EUCTR2007-001014-17-IT (EUCTR) | 26/07/2007 | 24/10/2007 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn?s disease - RETIC/03/06 | moderate active Crohn disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: NORMIX*AD 12CPR RIV 200MG INN or Proposed INN: Rifaximin | ALFA WASSERMANN | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | Hungary;Germany;France;Italy | ||
| 1862 | EUCTR2007-001014-17-FR (EUCTR) | 26/07/2007 | 01/06/2007 | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease | Treatment of moderate, active Crohn’s disease: induction of remission. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Rifaximin-EIR | Alfa Wassermann S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 424 | Phase 2 | France;Hungary;Germany;Italy | ||
| 1863 | EUCTR2006-003371-13-DE (EUCTR) | 17/07/2007 | 14/12/2006 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1864 | NCT01144156 (ClinicalTrials.gov) | July 2007 | 13/6/2010 | Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy | Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy | Crohn's Disease | Drug: Treatment with Adalimumab | Rabin Medical Center | Abbott | Not yet recruiting | 18 Years | N/A | Both | 30 | N/A | Israel |
| 1865 | NCT00513552 (ClinicalTrials.gov) | July 2007 | 6/8/2007 | Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis | Treatment of Crohn's Disease With an Antibiotic Regimen Directed Against Mycobacterium Avium Paratuberculosis | Crohn's Disease | Drug: Rifabutin, Clarithromycin, and Clofazimine | Medstar Health Research Institute | NULL | Withdrawn | 18 Years | 90 Years | All | 0 | Phase 4 | United States |
| 1866 | EUCTR2006-004784-58-BE (EUCTR) | 22/06/2007 | 11/04/2007 | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: remicade Product Name: remicade INN or Proposed INN: INFLIXIMAB | University of Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | United Kingdom;Germany;Belgium;France | |||
| 1867 | EUCTR2006-001729-24-ES (EUCTR) | 01/06/2007 | 01/06/2007 | Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Patients suffering from Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1868 | NCT00724529 (ClinicalTrials.gov) | June 2007 | 25/7/2008 | Post Marketing Surveillance of Remicade | Post Marketing Surveillance of Remicade in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ankylosing Spondylitis | Biological: Infliximab | Janssen Korea, Ltd., Korea | NULL | Completed | N/A | N/A | Both | 938 | Korea, Republic of | |
| 1869 | NCT00495521 (ClinicalTrials.gov) | June 2007 | 29/6/2007 | High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children | A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease | Crohn's Disease | Drug: 4-Aminosalicylic acid extended release granules | Jacobus Pharmaceutical | NULL | Terminated | 2 Years | 18 Years | All | 2 | Phase 2 | United States;Israel |
| 1870 | NCT00606346 (ClinicalTrials.gov) | May 31, 2007 | 21/1/2008 | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases | Biological: Anti TNF therapy including infliximab;Drug: No Biologics | Janssen Biotech, Inc. | NULL | Active, not recruiting | 1 Month | 17 Years | All | 4970 | United States;Canada | |
| 1871 | EUCTR2006-003371-13-NL (EUCTR) | 22/05/2007 | 19/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006) | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006) | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1872 | EUCTR2006-003371-13-FR (EUCTR) | 16/05/2007 | 29/12/2006 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | France;Czech Republic;Poland;Belgium;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1873 | EUCTR2006-001729-24-IT (EUCTR) | 10/05/2007 | 26/06/2007 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 | Patients suffering from Crohn's disease and having completed the C87042 study MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 | UCB PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 600 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1874 | EUCTR2006-001729-24-NL (EUCTR) | 10/05/2007 | 18/04/2007 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Sweden;Austria;Italy;Spain;France;Belgium;Netherlands;Germany;United Kingdom | |||
| 1875 | EUCTR2006-001729-24-AT (EUCTR) | 09/05/2007 | 18/12/2006 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1876 | NCT00467922 (ClinicalTrials.gov) | May 2007 | 27/4/2007 | An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy | A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid | Crohn's Disease;Ulcerative Colitis;Rectal Cancer;Colon Cancer;Colon Polyps;Rectal Polyps;Diverticulitis | Drug: Hextend;Drug: Lactated Ringers | Spectrum Health Hospitals | Deltex Medical, Inc. | Completed | 18 Years | 80 Years | Both | 69 | Phase 3 | United States |
| 1877 | EUCTR2006-001729-24-SE (EUCTR) | 25/04/2007 | 09/03/2007 | Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1878 | EUCTR2005-003977-25-DE (EUCTR) | 13/04/2007 | 05/03/2007 | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Germany;Belgium | ||
| 1879 | EUCTR2006-003371-13-BE (EUCTR) | 03/04/2007 | 24/01/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02, 03 & 08 + administrative letters 01 & 02.+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1880 | EUCTR2006-003371-13-DK (EUCTR) | 03/04/2007 | 09/03/2007 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.Revised Protocol 04 incorporating Amendments 02, 03, 08 & 09 (v1.0, date 09-Mar-2009) + administrative letters 01 & 02. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 2.0, Date: 26-Oct-2006). | Crohn's disease, NOS MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 709 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Denmark;France;Ireland;Italy;Poland | ||
| 1881 | NCT00409682 (ClinicalTrials.gov) | April 2007 | 8/12/2006 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab | Abbott | NULL | Completed | 6 Years | 17 Years | All | 192 | Phase 3 | United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy |
| 1882 | NCT00307931 (ClinicalTrials.gov) | April 2007 | 24/3/2006 | Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab | Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Terminated | 18 Years | N/A | All | 16 | Phase 3 | Greece |
| 1883 | EUCTR2006-003371-13-IT (EUCTR) | 09/03/2007 | 14/07/2008 | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - ND | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn?s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. - ND | Crohn's Disease, NOS MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: abatacept INN or Proposed INN: abatacept | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 906 | Phase 3 | Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Belgium;France;Ireland;Italy;Poland | ||
| 1884 | EUCTR2005-003827-38-BG (EUCTR) | 09/03/2007 | 01/03/2007 | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | A Multinational Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects with Moderate to Severe Crohn’s Disease | Subjects will be enrolled suffering from active, moderate to severe Crohn´s disease with a history of small bowel disease, with or without colonic disease. Their screening Crohn´s Disease Activity Index (CDAI) shall be between 250 and 450 inclusive and their fasting serum CRP concentration shall be above 7.5 mg/L. MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 336 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 1885 | JPRN-JapicCTI-070367 | 01/3/2007 | A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease | A Multi-Center, Randomized, Double-Blind, Placebo-controlled study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects with Crohn's Disease | Crohn's disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : Subcutaneous Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneous | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 15 | 75 | BOTH | 80 | Phase 2-3 | NULL | ||
| 1886 | NCT00462072 (ClinicalTrials.gov) | March 2007 | 17/4/2007 | Centocor Microarray Study of Patients | Microarray Analysis of Peripheral Blood and Tissues of Patients With Immune Mediated Inflammatory Diseases | Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Crohn's Disease | Drug: Infliximab | University of Rochester | Centocor, Inc. | Completed | 12 Years | N/A | All | 31 | Phase 4 | United States |
| 1887 | NCT00445432 (ClinicalTrials.gov) | March 2007 | 7/3/2007 | A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: adalimumab;Other: Placebo | Abbott | Eisai Co., Ltd. | Completed | 15 Years | 75 Years | All | 82 | Phase 2/Phase 3 | Japan |
| 1888 | EUCTR2006-002078-23-GR (EUCTR) | 27/02/2007 | 10/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 1889 | EUCTR2006-001729-24-FR (EUCTR) | 22/02/2007 | 22/01/2007 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 605 | Phase 3 | France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1890 | EUCTR2006-002078-23-GB (EUCTR) | 22/02/2007 | 09/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 1891 | EUCTR2006-001729-24-GB (EUCTR) | 14/02/2007 | 07/12/2006 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term clinical trial evaluating efficacy and safety of chronic therapy with certolizumab pegol, a PEGylated Fab fragment of humanised antibody to tumour necrosis factor alpha (TNFa) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 605 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | France;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1892 | EUCTR2006-002078-23-PT (EUCTR) | 06/02/2007 | 01/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1893 | EUCTR2006-003871-11-DE (EUCTR) | 06/02/2007 | 26/10/2006 | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II | The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | Germany | |||
| 1894 | JPRN-JapicCTI-070366 | 01/2/2007 | A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease | Crohn's disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : Subcutaneous Control intervention name : Placebo Dosage And administration of the control intervention : Subcutaneous | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 15 | 75 | BOTH | 80 | Phase 2-3 | NULL | ||
| 1895 | NCT00445939 (ClinicalTrials.gov) | February 2007 | 7/3/2007 | A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: adalimumab;Biological: placebo | Abbott | Abbott Japan Co.,Ltd;Eisai Co., Ltd. | Completed | 15 Years | 75 Years | All | 90 | Phase 2/Phase 3 | Japan |
| 1896 | EUCTR2005-003977-25-BE (EUCTR) | 31/01/2007 | 11/12/2006 | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | A phase III B multicentre open label 54 weeks clinical trial evaluating certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF alpha) on endoscopic and mucosal healing in patients suffering form active Crohn's disease - MUSIC | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | Germany;Belgium | ||
| 1897 | EUCTR2006-006632-22-BE (EUCTR) | 26/01/2007 | 19/12/2006 | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA Trade Name: REMICADE | University of Leuven, Division of Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Belgium | ||
| 1898 | EUCTR2006-001729-24-DE (EUCTR) | 16/01/2007 | 20/11/2006 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. - WELCOME 2 | Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol in patients suffering from Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma SA | NULL | Not Recruiting | Female: yes Male: yes | 605 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1899 | EUCTR2006-002078-23-SE (EUCTR) | 10/01/2007 | 09/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira Product Code: ABT Humira Product Name: Humira pre-filled PEN Product Code: ABT Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1900 | EUCTR2006-002078-23-FI (EUCTR) | 10/01/2007 | 31/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1901 | NCT00417690 (ClinicalTrials.gov) | January 2007 | 2/1/2007 | High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease | A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease | Crohn's Disease | Drug: 4-Aminosalicylic acid;Drug: PASER placebo granules | Jacobus Pharmaceutical | NULL | Terminated | 18 Years | 65 Years | Both | 54 | Phase 2 | United States;Israel |
| 1902 | NCT00427921 (ClinicalTrials.gov) | January 2007 | 26/1/2007 | Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | Crohn's Disease | Biological: adalimumab | Abbott | NULL | Completed | 18 Years | N/A | All | 304 | Phase 3 | United States |
| 1903 | NCT00354367 (ClinicalTrials.gov) | January 2007 | 18/7/2006 | Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas | A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas. | Crohn Disease | Drug: Certolizumab pegol | UCB Pharma | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | NULL |
| 1904 | NCT00427804 (ClinicalTrials.gov) | January 2007 | 25/1/2007 | Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption | Tumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium Absorption | Rheumatoid Arthritis;Crohn's Disease | Drug: calcitriol | Atlanta VA Medical Center | Emory University | Completed | 18 Years | 50 Years | Male | 9 | N/A | United States |
| 1905 | NCT00356408 (ClinicalTrials.gov) | January 2007 | 25/7/2006 | Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease | An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752). | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 106 | Phase 3 | United States;Canada;Germany |
| 1906 | EUCTR2006-002078-23-DE (EUCTR) | 07/12/2006 | 22/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1907 | NCT00409617 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | All | 945 | Phase 3 | Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Norway;Portugal;Slovakia;Spain;Sweden;Switzerland;United Kingdom;United States |
| 1908 | NCT00406653 (ClinicalTrials.gov) | December 2006 | 1/12/2006 | A Study of Abatacept in Patients With Active Crohn's Disease | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy | Crohn's Disease | Drug: abatacept;Drug: placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | N/A | All | 451 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;Argentina;Ireland;Korea, Republic of;Spain;United Kingdom |
| 1909 | NCT00417391 (ClinicalTrials.gov) | December 2006 | 28/12/2006 | Phase II Study of RR110 in Patients With Active Crohn's Disease | Phase II Study of RR110 in Patients With Active Crohn's Disease | Crohn's Disease | Drug: RR110 (Tamibarotene) | R&R Inc. | NULL | Completed | 20 Years | N/A | Both | 24 | Phase 2 | Japan |
| 1910 | EUCTR2006-003870-88-DE (EUCTR) | 27/11/2006 | 29/09/2006 | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | A Phase IIIb, multi-center, double-blind, placebo-controlled, randomized trial to examine the corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease (COSPAR I). - COSPAR I | In the present study, the corticosteroid-sparing effect of certolizumab pegol will be assessed in patients with moderate to severe Crohn’s disease who have received initial acute corticosteroid therapy (prednisone or prednisolone) for induction of remission. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | Phase 3 | Germany | ||
| 1911 | EUCTR2005-002319-26-HU (EUCTR) | 24/11/2006 | 23/03/2006 | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, pilot, four week, parallel-group, multicentre, phase II study | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, pilot, four week, parallel-group, multicentre, phase II study | Crohn's disease | Product Code: AZD9056 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Hungary;Germany;Belgium;Austria | ||
| 1912 | EUCTR2006-002078-23-DK (EUCTR) | 24/11/2006 | 26/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1913 | EUCTR2006-002078-23-FR (EUCTR) | 24/11/2006 | 29/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 1914 | EUCTR2006-002078-23-ES (EUCTR) | 23/11/2006 | 19/06/2013 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave. MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 | Trade Name: Humira Product Name: Humira pre-filled PEN Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 1915 | EUCTR2006-002078-23-CZ (EUCTR) | 21/11/2006 | 21/11/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece | |||
| 1916 | NCT00349752 (ClinicalTrials.gov) | November 2006 | 30/6/2006 | Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease | A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease. | Crohn's Disease | Biological: certolizumab pegol 400 mg;Other: Placebo | UCB Pharma | NULL | Terminated | 18 Years | N/A | All | 174 | Phase 3 | United States;Canada;Germany;Belgium |
| 1917 | EUCTR2005-005291-32-DE (EUCTR) | 24/10/2006 | 06/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1918 | EUCTR2006-002078-23-NO (EUCTR) | 23/10/2006 | 22/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 1919 | EUCTR2006-001729-24-BE (EUCTR) | 18/10/2006 | 01/09/2006 | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study. | Patients with Crohn's disease and having completed C87042 study. MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
| 1920 | EUCTR2006-002078-23-BE (EUCTR) | 16/10/2006 | 16/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 1921 | EUCTR2006-002078-23-NL (EUCTR) | 12/10/2006 | 10/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira INN or Proposed INN: adalimumab Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 1922 | EUCTR2005-000496-17-SE (EUCTR) | 06/10/2006 | 24/02/2005 | Atorvastatin in moderat active Crohns disease | Atorvastatin in moderat active Crohns disease | Crohn's disease is an idiopathic chronic inflammatory bowel disease thought to result from inappropriate and ongoing activation of the mucosal immune system driven by the presence of normal luminal flora. It may affect the hole gastrointestinal tract, from mouth to rectum, with symptoms such as diarrhea, weight lose, malabsorption, abdominal pain and fever. | Product Name: atorvastatin | Region Skåne | NULL | Not Recruiting | Female: yes Male: yes | 12 | Sweden | |||
| 1923 | NCT00573469 (ClinicalTrials.gov) | October 2006 | 13/12/2007 | Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | Crohn's Disease | Drug: D9421-C, 9mg;Drug: D9421-C, 15mg;Drug: Placebo | AstraZeneca | NULL | Completed | 18 Years | 65 Years | All | 75 | Phase 2 | Japan |
| 1924 | NCT00333788 (ClinicalTrials.gov) | October 2006 | 2/6/2006 | Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease | Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study. | Crohn's Disease | Biological: Certolizumab pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 233 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 1925 | EUCTR2006-002494-48-GB (EUCTR) | 27/09/2006 | 18/09/2006 | Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease | Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease | Active colonic Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon) | Trade Name: Viagra | University College London / University College London Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 15 | United Kingdom | |||
| 1926 | EUCTR2006-002078-23-AT (EUCTR) | 25/09/2006 | 04/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 1927 | EUCTR2005-005291-32-IT (EUCTR) | 14/09/2006 | 13/12/2006 | A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND | A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND | Crohn s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmbH Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1928 | NCT00663117 (ClinicalTrials.gov) | September 2006 | 18/4/2008 | The Effects of Naltrexone on Active Crohn's Disease | The Effects of Naltrexone in Active Crohn's Disease | Inflammation;Crohn's Disease | Drug: Naltrexone-HCl;Drug: Placebo | Milton S. Hershey Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);The Broad Foundation | Completed | 18 Years | 75 Years | All | 40 | Phase 2 | United States |
| 1929 | NCT00343642 (ClinicalTrials.gov) | September 2006 | 21/6/2006 | Dietary Treatment of Crohn's Disease | Dietary Treatment of Crohn's Disease | Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: Time and attention + fructo-oligosaccharide placebo;Dietary Supplement: dietary therapy + fructo-oligosaccharide placebo;Drug: Time and attention + active fructooligosaccharide supplementation | Rush University Medical Center | National Center for Complementary and Integrative Health (NCCIH) | Completed | 18 Years | 80 Years | Both | 73 | Phase 1/Phase 2 | United States |
| 1930 | NCT00588393 (ClinicalTrials.gov) | September 2006 | 22/12/2007 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 1931 | NCT00353756 (ClinicalTrials.gov) | September 2006 | 17/7/2006 | Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn’s Disease | A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn’s Disease | Crohn's Disease | Drug: C326, IL-6 Inhibitory Avimer protein | Avidia | NULL | Recruiting | 18 Years | 65 Years | Both | 52 | Phase 1 | Australia |
| 1932 | EUCTR2005-005291-32-NL (EUCTR) | 23/08/2006 | 28/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1933 | NCT00348283 (ClinicalTrials.gov) | August 2006 | 30/6/2006 | Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | Crohn's Disease | Biological: adalimumab;Biological: placebo | Abbott | NULL | Completed | 18 Years | 75 Years | All | 135 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden |
| 1934 | EUCTR2005-004104-37-ES (EUCTR) | 28/07/2006 | 11/05/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Belgium;Spain;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1935 | EUCTR2005-005291-32-SE (EUCTR) | 25/07/2006 | 12/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1936 | EUCTR2005-005291-32-BE (EUCTR) | 20/07/2006 | 03/05/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1937 | NCT00287170 (ClinicalTrials.gov) | July 2006 | 2/2/2006 | Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease | Pilot, Open-Label, Randomized, Parallel Group Study to Evaluate Clinical/ and Immunological Efficacy/Safety of Locally Delivered 6-MP or Calcitriol vs Purinethol in Non-Steroid Dependent Patients With Active CD | Crohn's Disease | Drug: Delayed Release 6MP or Calcitriol vs. Purinethol | Teva GTC | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 1/Phase 2 | Israel |
| 1938 | EUCTR2005-005291-32-AT (EUCTR) | 28/06/2006 | 28/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 1939 | EUCTR2005-004104-37-DK (EUCTR) | 15/06/2006 | 04/05/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Spain;Belgium;Austria;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 1940 | EUCTR2005-004104-37-SE (EUCTR) | 08/06/2006 | 21/04/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 1941 | NCT00338650 (ClinicalTrials.gov) | June 2006 | 19/6/2006 | Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE) | A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab | Crohn's Disease | Drug: adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 1000 | Phase 3 | United States |
| 1942 | NCT00305409 (ClinicalTrials.gov) | June 2006 | 20/3/2006 | Synbiotic Treatment in Crohn's Disease Patients | Synbiotic Treatment in Crohn's Disease Patients | Crohn's Disease | Drug: Synbiotic (Synergy I / B.longum) | University of Dundee | NULL | Completed | 18 Years | 79 Years | Both | 50 | N/A | United Kingdom |
| 1943 | NCT00329537 (ClinicalTrials.gov) | June 2006 | 23/5/2006 | Study of Sargramostim in Moderately to Severely Active Crohn's Disease | Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study) | Crohn's Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 11 | Phase 2 | Japan |
| 1944 | EUCTR2005-004104-37-AT (EUCTR) | 24/05/2006 | 04/04/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 1945 | EUCTR2005-004104-37-DE (EUCTR) | 19/05/2006 | 29/03/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a PEGylated Fab' fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Belgium;Spain;Italy;Austria;Sweden | ||
| 1946 | EUCTR2005-004104-37-GB (EUCTR) | 17/05/2006 | 17/03/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Belgium;Denmark;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 1947 | NCT00329420 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668) | A Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed no Clinical Efficacy in a Remission Induction Study (Study C87037) But Showed Clinical Efficacy After Additional Remission Induction Therapy Was Applied, at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 16 Years | 64 Years | All | 46 | Phase 2 | Japan |
| 1948 | NCT00317369 (ClinicalTrials.gov) | May 2006 | 21/4/2006 | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease | Crohn Disease | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | NULL | Terminated | 16 Years | 65 Years | Both | 60 | Phase 2 | Japan |
| 1949 | NCT00329550 (ClinicalTrials.gov) | May 2006 | 22/5/2006 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease | A 26-week, Multi-center, Open-label Study to Investigate the Efficacy and Safety of CDP870 in Active Crohn's Disease Patients, Who Showed Clinical Efficacy in a Remission Induction Study (Study C87037 [NCT00291668]), at Week 26 After Subcutaneous Administration of CDP870 400 mg From Week 8 Until Week 24 at 4-week Intervals | Crohn's Disease | Biological: Certolizumab pegol (CZP) | UCB Japan Co. Ltd. | NULL | Completed | 16 Years | 64 Years | All | 40 | Phase 2 | Japan |
| 1950 | NCT00257699 (ClinicalTrials.gov) | May 2006 | 22/11/2005 | Study of Antibiotics in the Treatment of Colonic Crohn's Disease | Metronidazole and Ciprofloxacin in the Treatment of Colonic Crohn's Disease: The MACINTOCC Trial. | Crohn's Disease | Drug: Metronidazole placebo;Drug: ciprofloxacin placebo;Drug: ciprofloxacin;Drug: metronidazole | Mount Sinai Hospital, Canada | Crohn's and Colitis Foundation | Terminated | 16 Years | N/A | Both | 12 | Phase 2 | Canada |
| 1951 | EUCTR2005-002319-26-AT (EUCTR) | 05/04/2006 | 22/02/2006 | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study - POPCRON | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study - POPCRON | Crohn's disease | Product Code: AZD9056 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Hungary;Germany;Belgium;Austria | ||
| 1952 | NCT00308581 (ClinicalTrials.gov) | April 2006 | 28/3/2006 | Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab | Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab | Crohn's Disease | Biological: Certolizumab pegol;Other: Placebo | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 539 | Phase 3 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom |
| 1953 | NCT00655733 (ClinicalTrials.gov) | April 2006 | 6/4/2008 | Phase II Study of HMPL-004 in Subjects With Crohn's Disease | Double-blind, Randomized, Multicenter, Placebo-controlled Phase II Study of Efficacy and Safety of HMPL-004 in Subjects With Active Moderate Crohn's Disease | Crohn's Disease | Drug: HMPL-004;Drug: Placebo | Hutchison Medipharma Limited | NULL | Completed | 18 Years | N/A | All | 101 | Phase 2 | United States |
| 1954 | EUCTR2005-004104-37-BE (EUCTR) | 23/03/2006 | 27/01/2006 | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | A Phase IIIb multicentre, open label induction and double blind comparison of two maintenance schedules evaluating clinical benefit and tolerability of certolizumab pegol, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn’s Disease with prior loss of response or intolerance to infliximab. | Patients with Crohn's Disease with prior loss of response or intolerance to infliximab Classification code 10011401 | Product Name: certolizumab pegol Product Code: CDP870 INN or Proposed INN: certolizumab pegol | UCB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Belgium;Spain;Italy;Austria;Sweden | ||
| 1955 | NCT00294112 (ClinicalTrials.gov) | March 13, 2006 | 17/2/2006 | Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease | A Phase II, Open-label, Randomized Study to Evaluate the Safety and Efficacy of PROCHYMAL™ IBD (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Treatment of Subjects Experiencing Moderate-to-severe Crohn's Disease That is Refractory to Steroids and Immune Suppressants | Crohn's Disease | Drug: Prochymal™ adult human mesenchymal stem cells;Drug: adult human mesenchymal stem cells | Mesoblast, Inc. | NULL | Completed | 18 Years | 70 Years | All | 10 | Phase 2 | United States |
| 1956 | NCT00291668 (ClinicalTrials.gov) | March 2, 2006 | 10/2/2006 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn's Disease | Biological: Certolizumab Pegol;Other: Placebo | UCB Pharma | NULL | Completed | 16 Years | 65 Years | All | 94 | Phase 2 | Japan |
| 1957 | NCT00306215 (ClinicalTrials.gov) | March 2006 | 21/3/2006 | A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease | A Multinational, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: CCX282-B | ChemoCentryx | NULL | Completed | 18 Years | N/A | Both | 436 | Phase 2 | Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;Netherlands;Poland;South Africa;Sweden;United Kingdom |
| 1958 | EUCTR2005-003337-40-GB (EUCTR) | 13/02/2006 | 13/01/2006 | Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC | Autologous Stem Cell Transplantation for Crohn's Disease ('ASTIC'-Trial: Autologous Stem Cell Transplantation International Crohn's Disease Trial) - ASTIC | Patients with Crohn's disease who have not responded to immunosupressant medication | Product Name: Cyclophosphamide Product Code: N/A INN or Proposed INN: cyclophosphamide Other descriptive name: N/A INN or Proposed INN: cyclophosphamide Other descriptive name: N/A Product Name: Filgrastim Product Code: N/A INN or Proposed INN: Filgrastim Other descriptive name: N/A Product Name: rabbit antithymocyte globulin Product Code: rbATG INN or Proposed INN: rabbit antithymocyte globulin Other descriptive name: N/A Product Name: Mesna Product Code: N/A INN or Proposed INN: mensa Other descriptive name: N/A Product Name: methyl prednisolone Product Code: N/A INN or Proposed INN: methyl prednisolone Other descriptive name: N/A Product Name: ciprofloxacin Product Code: N/A INN or Proposed INN: ciprofloxacin Other descriptive name: N/A | European Group for Blood and Marrow Transplantation (EMBT) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | United Kingdom | |||
| 1959 | NCT00587041 (ClinicalTrials.gov) | February 2006 | 21/12/2007 | Use of Oral Probiotics to Reduce Urinary Oxalate Excretion | Use of Oral Probiotics to Reduce Urinary Oxalate Excretion | Nephrolithiasis;Hyperoxaluria;Crohn's Disease | Dietary Supplement: Oxadrop;Dietary Supplement: Agri-King Synbiotic (AKSB);Other: Placebo | Mayo Clinic | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institutes of Health (NIH);National Center for Complementary and Integrative Health (NCCIH);National Center for Research Resources (NCRR) | Completed | 18 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
| 1960 | NCT00297648 (ClinicalTrials.gov) | February 2006 | 27/2/2006 | Mucosal Healing Study in Crohn's Disease (CD) | A Phase IIIB Multicentre Open Label 54 Weeks Clinical Trial Evaluating Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNFa) on Endoscopic and Mucosal Healing in Patients Suffering From Active Crohn's Disease. | Crohn's Disease | Biological: Certolizumab pegol | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 89 | Phase 3 | Belgium;France;Germany |
| 1961 | NCT00727298 (ClinicalTrials.gov) | February 2006 | 30/7/2008 | Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840) | Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases | Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Psoriasis;Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | 18 Years | N/A | All | 4485 | N/A | Germany |
| 1962 | NCT00583232 (ClinicalTrials.gov) | February 2006 | 20/12/2007 | Protein and Energy Metabolism in Pediatric Crohn's Disease | Protein and Energy Metabolism in Pediatric Crohn's Disease | Crohn's Disease;Protein Metabolism;Energy Metabolism | Drug: Stable isotope infusions | Indiana University | GlaxoSmithKline;Crohn's and Colitis Foundation;National Center for Research Resources (NCRR) | Completed | 6 Years | 18 Years | All | 15 | Phase 1 | United States |
| 1963 | NCT00630643 (ClinicalTrials.gov) | January 2006 | 28/2/2008 | NI-0401 in Active Crohn's Disease | A Phase I/IIa, Double-Blind, Placebo-Controlled, Dose-Escalation Study of NI-0401 in Patients With Moderate to Severe Active Crohn´s Disease | Moderate to Severe Crohn's Disease | Biological: NI-0401 (anti-CD3 mAB);Drug: Placebo | NovImmune SA | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 1/Phase 2 | NULL |
| 1964 | NCT00295165 (ClinicalTrials.gov) | January 2006 | 21/2/2006 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 33 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine |
| 1965 | EUCTR2005-002319-26-BE (EUCTR) | 23/12/2005 | 13/12/2005 | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Crohn's disease | Product Code: AZD9056 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Hungary;Germany;Belgium;Austria | ||
| 1966 | EUCTR2005-002319-26-DE (EUCTR) | 20/12/2005 | 28/10/2005 | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study | Crohn's disease | Product Code: AZD9056 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Hungary;Germany;Belgium;Austria | ||
| 1967 | EUCTR2004-002815-10-DE (EUCTR) | 12/12/2005 | 25/04/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 1968 | JPRN-C000000300 | 2005/12/01 | 22/12/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - | Patients with Crohn's disease in active phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. Placebo group:Three tablets of Z-206 placebo tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 12 weeks. | Zeria Pharmaceutical Co.,LTD | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 60 | Phase 3 | Japan | |
| 1969 | JPRN-C000000301 | 2005/12/01 | 22/12/2005 | Z-206 Phase III Clinical Trial-Investigation on the remission–maintaining effect in patients with Crohn's disease in remission phase- | Patients with Crohn's disease in remission phase | Z-206 group:Three tablets of Z-206 400mg tablet, 4 tablets of Pentasa placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group:Four tablets of Pentasa 250mg tablet, 3 tablets of Z-206 placebo tablet per time (total 7 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 40 | Phase 2,3 | Japan | |
| 1970 | NCT00132899 (ClinicalTrials.gov) | December 2005 | 19/8/2005 | COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial) | A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Evaluate the Safety and Efficacy of Infliximab in Combination With Methotrexate for the Long-term Treatment of Crohn's Disease (CD) | Crohn's Disease | Drug: Methotrexate;Drug: Placebo | University of Western Ontario, Canada | Schering-Plough | Completed | 18 Years | N/A | Both | 128 | Phase 3 | Canada |
| 1971 | NCT00571337 (ClinicalTrials.gov) | December 2005 | 25/7/2007 | Stop Infliximab in Patients With Crohn's Disease | Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab | Crohn Disease | Drug: Infliximab | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Completed | 18 Years | N/A | Both | 126 | Phase 3 | Belgium;France |
| 1972 | NCT00250198 (ClinicalTrials.gov) | November 3, 2005 | 5/11/2005 | The Immunological and Blood Effects of STA-5326 Mesylate on Patients With Crohn's Disease | A Randomized, Double-blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 75 Years | All | 12 | Phase 2 | United States |
| 1973 | NCT00265772 (ClinicalTrials.gov) | November 2005 | 14/12/2005 | Comparison of a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis | Phase IV Study Comparing a Nutritional Anti-Inflammatory Treatment to Steroids for Pediatric Crohn's Disease - the Molecular Basis | Crohn's Disease;Pediatric | Drug: MODULEN IBD (R) (specific Enteral Nutrition);Drug: prednisolon | Hôpital Necker-Enfants Malades | Institut National de la Santé Et de la Recherche Médicale, France;Nestlé | Recruiting | 6 Years | 18 Years | Both | 24 | Phase 4 | France |
| 1974 | NCT00234741 (ClinicalTrials.gov) | November 2005 | 5/10/2005 | Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Pilot Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, to Investigate Peripheral Blood and Mucosal Mononuclear Cell Phenotype and Cytokine Responses in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 mesylate | Synta Pharmaceuticals Corp. | National Institute of Allergy and Infectious Diseases (NIAID);National Institutes of Health (NIH) | Completed | 18 Years | 75 Years | Both | 12 | Phase 2 | United States |
| 1975 | NCT00838149 (ClinicalTrials.gov) | November 2005 | 5/2/2009 | Effect of Glutamine on Intestinal Permeability in Crohn's Disease | Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial | Crohn's Disease | Dietary Supplement: Glutamine;Dietary Supplement: Whey protein | All India Institute of Medical Sciences, New Delhi | NULL | Completed | 15 Years | 60 Years | Both | 30 | Phase 1 | India |
| 1976 | NCT00225810 (ClinicalTrials.gov) | October 2005 | 22/9/2005 | A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease | Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease | Crohn's Disease | Drug: Crohn's Disease | Ferring Pharmaceuticals | NULL | Completed | 8 Years | 18 Years | Both | 50 | Phase 4 | Czech Republic |
| 1977 | NCT02247258 (ClinicalTrials.gov) | October 2005 | 19/9/2014 | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence. | Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study. | Crohn Disease;Recurrence;Azathioprine;Prevention | Drug: Azathioprine;Drug: Azathioprine in case of endoscopic recurrence;Procedure: Ileocolonoscopy;Procedure: Small bowel follow trough | Universitaire Ziekenhuizen Leuven | International organization for the study of inflammatory bowel disease (IOIBD) | Terminated | 16 Years | 75 Years | Both | 63 | Phase 2 | Belgium;Czech Republic;Greece |
| 1978 | EUCTR2005-002472-15-SE (EUCTR) | 22/09/2005 | 23/06/2005 | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | The effect on mucosal healing with Pentasa® Sachet 4 g in mild to moderate active small bowel Crohn's disease, evaluated with video capsule endoscopy after 6 and 12 weeks treatment. A pilot study. - N.A. | Mild to moderate active Crohn's disease MedDRA version: 7.1;Level: PT;Classification code 10011401 | Trade Name: Pentasa Sachet 1 g prolonged release granules Product Name: Pentasa Sachet 1 g INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicylic acid | Ferring Laegemidler A/S | NULL | Not Recruiting | Female: yes Male: yes | 10 | Sweden | |||
| 1979 | NCT00252369 (ClinicalTrials.gov) | September 2005 | 10/11/2005 | Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment. | Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease. | Crohn's Disease | Drug: Infliximab;Procedure: Instillation of fibrin glue | Sheba Medical Center | NULL | Terminated | 18 Years | 90 Years | Both | N/A | Israel | |
| 1980 | NCT00130390 (ClinicalTrials.gov) | August 2005 | 12/8/2005 | Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease | Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults | Crohn's Disease | Drug: Nitazoxanide;Other: Placebo | Romark Laboratories L.C. | NULL | Terminated | 18 Years | N/A | Both | 98 | Phase 2 | United States |
| 1981 | NCT00138840 (ClinicalTrials.gov) | August 2005 | 26/8/2005 | Study of STA-5326 Mesylate in Patients With Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, for the Induction of Clinical Response in Patients With Crohn's Disease | Crohn's Disease | Drug: STA-5326 mesylate | Synta Pharmaceuticals Corp. | NULL | Completed | 18 Years | 75 Years | Both | 282 | Phase 2 | United States;Canada |
| 1982 | EUCTR2004-002815-10-GB (EUCTR) | 25/07/2005 | 26/05/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Spain;Denmark;Austria;Germany;United Kingdom;Sweden | ||
| 1983 | EUCTR2004-002815-10-DK (EUCTR) | 07/07/2005 | 10/07/2008 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 1984 | NCT00113503 (ClinicalTrials.gov) | July 2005 | 8/6/2005 | Imuran Dosing in Crohn's Disease Study | A Multi-site Trial of Azathioprine Dosing in Crohn's Disease | Crohn's Disease | Drug: Azathioprine weight-based dose;Drug: Azathioprine individualised dose | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Prometheus Laboratories | Terminated | 10 Years | 70 Years | All | 50 | Phase 2 | United States;Canada |
| 1985 | NCT00167882 (ClinicalTrials.gov) | July 2005 | 9/9/2005 | The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: 5-aminosalicylate (Pentasa, Ferring) | VU University Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | |
| 1986 | NCT00546546 (ClinicalTrials.gov) | July 2005 | 18/10/2007 | Early Immunosuppressants in Crohn's Disease | Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease | Crohn's Disease | Drug: early immunosuppressants (azathioprine, methotrexate) | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Société Nationale Française de Gastroentérologie;Société Nationale Française de Gastroentérologie | Completed | 18 Years | N/A | Both | 120 | Phase 4 | France |
| 1987 | EUCTR2005-001148-22-SK (EUCTR) | 27/06/2005 | 12/05/2005 | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | Crohn's disease MedDRA version: 7.1;Level: Low;Classification code 10011401 | Trade Name: Certican Product Name: Certican Product Code: RAD001 INN or Proposed INN: Everolimus Trade Name: Imuran Product Name: Imuran INN or Proposed INN: Azathioprine | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Slovakia | ||
| 1988 | NCT00114465 (ClinicalTrials.gov) | June 2005 | 14/6/2005 | VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease | Randomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's Disease | Crohn's Disease | Drug: VSL#3;Other: Placebo | Orphan Australia | NULL | Completed | 18 Years | 75 Years | Both | 38 | Phase 4 | Australia |
| 1989 | EUCTR2004-002815-10-SE (EUCTR) | 24/05/2005 | 11/04/2005 | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing REMICADE® (infliximab) and REMICADE® plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease) SONIC - SONIC | moderate to severe Crohn’s Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: Chimeric IgG1 monoclonal antibody Trade Name: Imuran INN or Proposed INN: azathioprine Other descriptive name: 6-[(methyl-4-nitro-1H-imidazol-5-yl)thio]-1H-purine | Centocor B.V. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Germany;Denmark;Spain;Sweden | |||
| 1990 | NCT00126373 (ClinicalTrials.gov) | May 2005 | 2/8/2005 | A Trial of Wellbutrin for Crohn's Disease | A Randomized Controlled Trial of Wellbutrin for Crohn's Disease | Crohn Disease | Drug: Wellbutrin (bupropion) | Altschuler, Eric, M.D. | GlaxoSmithKline | Completed | 18 Years | N/A | Both | 1 | Phase 2/Phase 3 | United States |
| 1991 | NCT00509639 (ClinicalTrials.gov) | May 2005 | 30/7/2007 | Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease | Phase III Study to Evaluate the Effect of 10% Metronidazole Ointment, Applied Topically Three Times a Day in and Around the Anus and the Change in Perianal Crohn's Disease Activity | Crohn's Disease | Drug: 10% Metronidazole Ointment | S.L.A. Pharma AG | NULL | Completed | 18 Years | N/A | Both | 74 | Phase 3 | United States;United Kingdom |
| 1992 | EUCTR2004-004854-19-SK (EUCTR) | 25/04/2005 | 09/02/2005 | A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | A randomized, double-blind, placebo-controlled, parallel group multicenter study to investigate efficacy and safety of ITF 2357 in the management of patients with active moderate to severe Crohn’s disease | Crohn's disease | Product Name: ITF2357 Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethyl)-naphtalen-2-ylmethyl]-ammonium chloride mon | Italfarmaco S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 2 | Slovakia | ||
| 1993 | NCT00271947 (ClinicalTrials.gov) | April 2005 | 2/1/2006 | Crohn's Disease Stem Cell Transplantation | Crohn's Disease Non-myeloablative Autologous Hematopoietic Stem Cell Transplantation (CDNST) Versus Standard Therapy | Crohn's Disease | Biological: Autologous Stem Cell Transplantation | Northwestern University | NULL | Terminated | 18 Years | 55 Years | All | 1 | Phase 2 | United States |
| 1994 | NCT00705471 (ClinicalTrials.gov) | April 2005 | 23/6/2008 | Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED) | Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources | Crohn Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Terminated | 18 Years | N/A | Both | 42 | N/A | NULL |
| 1995 | NCT00109473 (ClinicalTrials.gov) | April 2005 | 28/4/2005 | Trial of Growth Hormone Therapy in Pediatric Crohn's Disease | A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn's Disease | Crohn's Disease | Drug: growth hormone;Drug: cortecosteroid | Children's Hospital Medical Center, Cincinnati | Genentech, Inc. | Completed | 5 Years | N/A | All | 22 | Phase 2 | United States |
| 1996 | NCT00098111 (ClinicalTrials.gov) | April 2005 | 3/12/2004 | Imuran (Azathioprine) Dose-Ranging Study in Crohn's Disease | A Double-Blinded, Randomized, Parallel Arm, Dose Ranging Study of IMURAN in Subjects With Active Crohn's Disease Requiring Treatment With Prednisone: A Crohn's Disease Optimal Range Dose of IMURAN Study (ACORDIS) | Crohn's Disease | Drug: azathioprine | Massachusetts General Hospital | NULL | Terminated | 14 Years | N/A | Both | 31 | Phase 3 | United States |
| 1997 | NCT00094458 (ClinicalTrials.gov) | March 2005 | 19/10/2004 | Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na?ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC | Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE? (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy | Crohn Disease | Biological: infliximab infusion; AZA placebo caps;Other: infliximab (IFX) infusion; azathioprine (AZA) caps;Drug: infliximab (IFX) placebo infusion | Centocor Ortho Biotech Services, L.L.C. | Schering-Plough | Completed | 21 Years | 99 Years | All | 508 | Phase 3 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Netherlands;Norway;Portugal;Spain;Sweden;United Kingdom |
| 1998 | EUCTR2004-002163-24-IT (EUCTR) | 28/02/2005 | 15/06/2005 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmBH Co KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;United Kingdom;Italy | |||
| 1999 | EUCTR2004-002934-20-BE (EUCTR) | 22/02/2005 | 08/07/2005 | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 2000 | EUCTR2004-002163-24-DE (EUCTR) | 09/02/2005 | 25/10/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 2001 | EUCTR2004-003839-31-DK (EUCTR) | 05/02/2005 | 17/05/2005 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | A Phase III, Multicenter, Open-Label, Long-Term Study of the Tolerability of Intravenous Natalizumab in Crohn's Disease Subjects Who Have Previously Participated in Natalizumab Crohn's Disease Study CD351 - CD354 | Crohn's Disease (CD) | Product Name: natalizumab Product Code: AN100226 INN or Proposed INN: natalizumab | Elan Pharma Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Denmark | ||
| 2002 | NCT00267722 (ClinicalTrials.gov) | February 2005 | 19/12/2005 | Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease | A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease | Crohn's Disease | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Completed | 18 Years | 70 Years | Both | 18 | Phase 2 | United States |
| 2003 | NCT00267709 (ClinicalTrials.gov) | February 2005 | 19/12/2005 | Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease | A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease | Crohn's Disease | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Completed | 18 Years | 70 Years | Both | 18 | Phase 2 | United States |
| 2004 | NCT00688636 (ClinicalTrials.gov) | January 2005 | 29/5/2008 | Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery | Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery | Crohn's Disease | Drug: infliximab;Drug: placebo | University of Pittsburgh | Centocor, Inc. | Completed | 18 Years | 72 Years | All | 24 | Phase 4 | United States |
| 2005 | NCT00106314 (ClinicalTrials.gov) | January 2005 | 22/3/2005 | An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease | A Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's Disease | Crohn's Disease | Drug: Dehydroepiandrosterone [DHEA] | Inflabloc Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States;Canada |
| 2006 | EUCTR2004-002163-24-SE (EUCTR) | 30/12/2004 | 12/11/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 2007 | EUCTR2004-002163-24-ES (EUCTR) | 17/12/2004 | 07/06/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 2008 | NCT00221026 (ClinicalTrials.gov) | December 2004 | 13/9/2005 | Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease | A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents | Crohn's Disease | Drug: Methoxsalen +ECP;Procedure: Extracorporeal Photopheresis | Mallinckrodt | ICON plc | Completed | 18 Years | N/A | Both | 25 | Phase 2 | United States;Austria;Belgium;Germany |
| 2009 | NCT00724958 (ClinicalTrials.gov) | December 2004 | 25/7/2008 | Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED) | Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension | Crohn's Disease | Biological: Infliximab | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | N/A | N/A | All | 348 | N/A | Austria |
| 2010 | NCT00206661 (ClinicalTrials.gov) | December 2004 | 12/9/2005 | Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease | Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | NULL | Terminated | 6 Years | 16 Years | Both | 22 | Phase 1/Phase 2 | United States |
| 2011 | EUCTR2004-002163-24-BE (EUCTR) | 25/11/2004 | 19/08/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 2012 | EUCTR2004-002163-24-HU (EUCTR) | 23/11/2004 | 13/10/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 2013 | EUCTR2004-002163-24-DK (EUCTR) | 16/11/2004 | 09/07/2008 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 2014 | NCT00105300 (ClinicalTrials.gov) | October 2004 | 11/3/2005 | Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab | Crohn's Disease | Drug: Adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 300 | Phase 3 | United States;Belgium;Canada;France |
| 2015 | NCT00599625 (ClinicalTrials.gov) | October 2004 | 26/12/2007 | Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study | Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study | Crohn's Disease | Drug: Pravastatin | University of Virginia | American College of Gastroenterology | Recruiting | 18 Years | 65 Years | Both | 40 | N/A | United States |
| 2016 | NCT00101946 (ClinicalTrials.gov) | October 2004 | 18/1/2005 | Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's Disease | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: 683699 | GlaxoSmithKline | NULL | Completed | 18 Years | 65 Years | Both | 17 | Phase 2 | United States;Canada |
| 2017 | NCT00798473 (ClinicalTrials.gov) | September 2004 | 25/11/2008 | Zoledronate for Osteopenia in Pediatric Crohn's | A Randomized Controlled Trial of Zoledronate in the Treatment of Osteopenia in Children and Adolescents With Crohn's Disease | Crohn's Disease;Osteopenia;Osteoporosis | Drug: zoledronic acid;Other: IV saline infusion | McGill University Health Center | Crohn's and Colitis Foundation | Completed | 6 Years | 18 Years | Both | 13 | Phase 3 | Canada |
| 2018 | NCT00195715 (ClinicalTrials.gov) | September 2004 | 13/9/2005 | Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease | A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease | Crohn's Disease | Biological: Adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | All | 777 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Hungary;Italy;Netherlands;Poland;South Africa;Spain;Sweden;United Kingdom |
| 2019 | NCT00206674 (ClinicalTrials.gov) | September 2004 | 13/9/2005 | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease | Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | N/A | Both | 286 | Phase 3 | Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 2020 | NCT00300118 (ClinicalTrials.gov) | September 2004 | 7/3/2006 | Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD) | Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients | Crohn's Disease | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 311 | Phase 3 | Germany |
| 2021 | NCT00160524 (ClinicalTrials.gov) | July 2004 | 8/9/2005 | A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032 | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | NULL | Completed | 18 Years | N/A | All | 596 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Georgia;Germany;Hong Kong;Hungary;Israel;Italy;Latvia;Lithuania;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Sweden;Ukraine;Czech Republic;Tunisia |
| 2022 | NCT00206713 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim | Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 264 | Phase 3 | United States |
| 2023 | NCT00245947 (ClinicalTrials.gov) | April 2004 | 26/10/2005 | Study Evaluating ERB-041 in Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease | Crohn's Disease | Drug: ERB-041 | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 18 Years | N/A | Both | 22 | Phase 1 | NULL |
| 2024 | NCT00265122 (ClinicalTrials.gov) | April 2004 | 13/12/2005 | A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease | A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IV | Centocor, Inc. | NULL | Completed | 18 Years | N/A | All | 131 | Phase 2 | United States;Belgium;Canada |
| 2025 | NCT00308438 (ClinicalTrials.gov) | March 1, 2004 | 13/9/2005 | Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008 | An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008 | Crohn's Disease | Drug: Teduglutide (ALX-0600) | Shire | NULL | Completed | 18 Years | N/A | All | 67 | Phase 2 | United States;Canada |
| 2026 | NCT00078611 (ClinicalTrials.gov) | March 2004 | 1/3/2004 | A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease | A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | Both | 462 | Phase 3 | United States;Canada |
| 2027 | NCT00160706 (ClinicalTrials.gov) | February 2004 | 8/9/2005 | A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease | A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease. | Crohn's Disease | Biological: Certolizumab Pegol (CDP870) | UCB Pharma SA | NULL | Completed | 18 Years | N/A | All | 310 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;Russian Federation;Serbia;Singapore;Slovenia;South Africa;Spain;Ukraine;Czech Republic |
| 2028 | NCT00224562 (ClinicalTrials.gov) | February 2004 | 14/9/2005 | The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists | The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists | Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis | Drug: TNF-alpha antagonists | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | N/A | N/A | Both | N/A | France | |
| 2029 | NCT00152425 (ClinicalTrials.gov) | February 2004 | 7/9/2005 | Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870). | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870 | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 392 | Phase 3 | NULL |
| 2030 | NCT00088062 (ClinicalTrials.gov) | February 2004 | 19/7/2004 | STA-5326 in Crohn's Disease Patients | A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450 | Crohn's Disease | Drug: STA-5326 | Synta Pharmaceuticals Corp. | NULL | Completed | 18 Years | 65 Years | Both | 48 | Phase 1/Phase 2 | United States |
| 2031 | NCT00114803 (ClinicalTrials.gov) | January 2004 | 17/6/2005 | Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease | Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study | Ulcerative Colitis;Crohn's Disease | Drug: Calcitonin nasal spray (salmon) | Children's Hospital Boston | Crohn's and Colitis Foundation;National Institutes of Health (NIH) | Completed | 8 Years | 22 Years | Both | 66 | N/A | United States |
| 2032 | NCT00175292 (ClinicalTrials.gov) | December 2003 | 13/9/2005 | A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease. | A Randomized and Placebo-Controlled Double-Blind Multicentre Study to Determine the Efficacy and Safety of VSL#3 Probiotic Food Supplement Mixture in Prevention of Endoscopic Recurrence in Crohn's Disease Patients With Ileocolonic Surgical Resection and Small Intestine to Colon Anastomosis. | Crohn's Disease;Inflammatory Bowel Disease | Drug: Probiotic - VSL#3 | University of Alberta | Canadian Institutes of Health Research (CIHR) | Completed | 16 Years | N/A | Both | 120 | Phase 3 | Canada |
| 2033 | NCT00152490 (ClinicalTrials.gov) | December 2003 | 8/9/2005 | A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo) | A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease | Crohn's Disease | Drug: Certolizumab Pegol (CDP870) | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 604 | Phase 3 | NULL |
| 2034 | NCT00177866 (ClinicalTrials.gov) | December 2003 | 13/9/2005 | Safety of Celecoxib in Patients With Crohn's Disease | The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease | Crohn's Disease | Drug: Celebrex;Drug: placebo | University of Pittsburgh | Shadyside Hospital Foundation;Pfizer | Terminated | 18 Years | 70 Years | All | 28 | Phase 4 | United States |
| 2035 | NCT00072839 (ClinicalTrials.gov) | November 12, 2003 | 11/11/2003 | Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease | A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease | Crohn's Disease | Drug: ALX-0600;Drug: placebo;Drug: teduglutide 0.05;Drug: teduglutide 0.2 mg;Drug: Teduglutide 0.05 dose;Drug: teduglutide 0.1 mg dose | Shire | NULL | Completed | 18 Years | N/A | All | 100 | Phase 2 | United States;Canada |
| 2036 | NCT00796250 (ClinicalTrials.gov) | November 1, 2003 | 21/11/2008 | Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732) | Efficacy of Infliximab as Bridging Therapy in the Treatment of Patients Affected by Corticodependent Crohn's Disease Under Standard Treatment With Azathioprine | Crohn's Disease | Biological: Infliximab;Drug: AZA;Drug: Placebo Prednisolone;Drug: Prednisolone;Biological: Placebo Infliximab | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 3 | NULL |
| 2037 | NCT00723047 (ClinicalTrials.gov) | November 2003 | 25/7/2008 | Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial | Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial | Crohn's Disease | Procedure: Fibrin glue injection in fistula | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Nycomed;Société Nationale Française de Gastroentérologie | Completed | 18 Years | N/A | Both | 77 | Phase 3 | Belgium;France |
| 2038 | NCT00741910 (ClinicalTrials.gov) | July 2003 | 22/8/2008 | Extension Study of Semapimod 60 mg IV x 3 Days | Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | Crohn's Disease | Drug: Semapimod | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 2 | United States;Germany;Israel;Netherlands |
| 2039 | NCT00077779 (ClinicalTrials.gov) | July 2003 | 12/2/2004 | Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 854 | Phase 3 | United States |
| 2040 | NCT00206596 (ClinicalTrials.gov) | July 2003 | 12/9/2005 | Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease | Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine);Drug: Placebo | Genzyme, a Sanofi Company | NULL | Completed | 18 Years | 80 Years | Both | 127 | Phase 2 | United States;Canada |
| 2041 | NCT00705614 (ClinicalTrials.gov) | July 2003 | 23/6/2008 | Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035) | Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy | Crohn's Disease | Biological: Remicade | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 2662 | N/A | NULL |
| 2042 | NCT00056355 (ClinicalTrials.gov) | March 2003 | 10/3/2003 | Extracorporeal Photopheresis to Maintain Symptoms Remission During Steroid Withdrawal in Patients With Steroid-Dependent Crohn's Disease | A Single Arm Study of Extracorporeal Photoimmune Therapy With Uvadex For Corticosteroid Sparing in Patients With Corticosteroid-Dependent Crohn's Disease Who May Also Be Refractory or Intolerant to Immunosuppressants and/or Anti-Tumor Necrosis Factor Agen | Crohn Disease | Drug: UVADEX and UVAR XTS Photopheresis System | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | N/A | N/A | Both | 10 | Phase 1 | United States |
| 2043 | NCT00206700 (ClinicalTrials.gov) | February 2003 | 13/9/2005 | Open-label Trial of Leukine in Active Crohn's Disease | Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease | Crohn Disease | Drug: Sargramostim (Leukine) | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 378 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom |
| 2044 | NCT00207675 (ClinicalTrials.gov) | February 2003 | 13/9/2005 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease | A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease. | Crohn Disease | Drug: infliximab | Centocor, Inc. | Centocor BV | Completed | 6 Years | 17 Years | Both | 112 | Phase 3 | NULL |
| 2045 | NCT00613197 (ClinicalTrials.gov) | January 2003 | 15/1/2008 | EPANOVA in Crohn's Disease, Study 1 | A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease. | Crohn's Disease | Drug: Epanova | Tillotts Pharma AG | NULL | Completed | 18 Years | 70 Years | Both | 384 | Phase 3 | Belgium |
| 2046 | NCT00818272 (ClinicalTrials.gov) | December 2002 | 6/1/2009 | Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED) | Remicade Safety Line (Crohn's Disease) | Crohn's Disease | Biological: Remicade (infliximab) | Merck Sharp & Dohme Corp. | Centocor, Inc. | Completed | 18 Years | N/A | All | 148 | N/A | Germany |
| 2047 | NCT00740103 (ClinicalTrials.gov) | December 2002 | 21/8/2008 | Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease | Long-term Study of Semapimod (CNI-1493) for Treatment of Moderate to Severe Crohn's Disease With Reference to Study CNI-1493-CD-04, 1 or 3 Days' Treatment vs. Placebo | Crohn's Disease | Drug: Semapimod | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 119 | Phase 2 | United States;Belgium;Germany;Israel;Netherlands |
| 2048 | NCT00739986 (ClinicalTrials.gov) | October 2002 | 20/8/2008 | Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo | A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo | Crohn's Disease | Drug: Semapimod;Drug: Placebo | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 152 | Phase 2 | United States;Belgium;Germany;Israel;Netherlands |
| 2049 | NCT00074542 (ClinicalTrials.gov) | September 2002 | 15/12/2003 | An Efficacy and Safety Study of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease | A Phase III Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Multi-Centre Study to Assess the Efficacy and Safety of Omega-3 Free Fatty Acids (Epanova™) for the Maintenance of Symptomatic Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Epanova™ (Omega-3 Free Fatty Acids) | Tillotts Pharma AG | NULL | Completed | 16 Years | N/A | Both | 364 | Phase 3 | United States;Canada |
| 2050 | NCT01070303 (ClinicalTrials.gov) | August 2002 | 16/2/2010 | Remission in Subjects With Crohn's Disease, Open Label Extension | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension | Crohn's Disease | Biological: Adalimumab 40 mg eow or ew | Abbott | NULL | Completed | 18 Years | 75 Years | All | 177 | Phase 3 | United States |
| 2051 | NCT00055497 (ClinicalTrials.gov) | August 2002 | 3/3/2003 | Remission in Subjects With Crohn's Disease, 1 Year Phase | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Biological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mg | Abbott | NULL | Completed | 18 Years | 75 Years | All | 276 | Phase 3 | United States |
| 2052 | NCT00042055 (ClinicalTrials.gov) | July 2002 | 22/7/2002 | CP-461 for the Treatment of Crohn's Disease | A Phase II Pilot Study of CP-461 in the Treatment of Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: CP-461 | Astellas Pharma Inc | Cell Pathways;OSI Pharmaceuticals | Completed | 18 Years | N/A | Both | 30 | Phase 2 | United States |
| 2053 | NCT00280956 (ClinicalTrials.gov) | July 2002 | 21/1/2006 | Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease | A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | Both | 2000 | Phase 4 | United States |
| 2054 | NCT00275418 (ClinicalTrials.gov) | July 2002 | 10/1/2006 | Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease | Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission | Crohn's Disease | Drug: beta carotene from Dunaliella algae | Bnai Zion Medical Center | NULL | Recruiting | 17 Years | 75 Years | Both | 300 | Phase 3 | Israel |
| 2055 | NCT00152841 (ClinicalTrials.gov) | June 2002 | 7/9/2005 | Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis | Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ulcerative Colitis;Mild or Moderate Anaemia | Drug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IU | University Health Network, Toronto | Crohn's and Colitis Foundation | Terminated | 18 Years | N/A | Both | 30 | Phase 2 | Canada |
| 2056 | NCT00038766 (ClinicalTrials.gov) | June 2002 | 5/6/2002 | CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease | Crohn Disease | Drug: semapimod;Drug: placebo | Ferring Pharmaceuticals | NULL | Terminated | 18 Years | N/A | Both | 33 | Phase 2 | United States |
| 2057 | NCT00048295 (ClinicalTrials.gov) | May 2002 | 29/10/2002 | Alicaforsen (ISIS 2302) in Patients With Active Crohn’s Disease | ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn’s Disease | Crohn's Disease | Drug: Alicaforsen | Isis Pharmaceuticals | NULL | Active, not recruiting | 12 Years | N/A | Both | 150 | Phase 3 | Belgium;Czech Republic;Germany;Italy;Poland;Spain |
| 2058 | NCT00055523 (ClinicalTrials.gov) | April 2002 | 4/3/2003 | A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab (D2E7) | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 300 | Phase 2 | United States |
| 2059 | NCT00055536 (ClinicalTrials.gov) | April 2002 | 4/3/2003 | Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease | A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | Both | 60 | Phase 2 | United States |
| 2060 | NCT00040521 (ClinicalTrials.gov) | April 2002 | 27/6/2002 | Study Evaluating rhIL-11 in Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease | Crohn Disease;Inflammatory Bowel Disease | Drug: Recombinant Human Interleukin-11 (rhIL-11) | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Completed | 16 Years | N/A | Both | Phase 2 | United States | |
| 2061 | NCT00055367 (ClinicalTrials.gov) | April 2002 | 26/2/2003 | Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease | A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 12 Years | 17 Years | Both | 30 | Phase 2 | United States;United Kingdom |
| 2062 | NCT00032786 (ClinicalTrials.gov) | March 2002 | 3/4/2002 | Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease | A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
| 2063 | NCT00072943 (ClinicalTrials.gov) | March 2002 | 12/11/2003 | A Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) for Moderate to Severe Crohn's Disease | A Phase II, Double-Blind, Placebo-Controlled Study to Determine the Safety and Efficacy of a Humanized Anti-Interferon-? Monoclonal Antibody (HuZAF) Administered to Patients With Moderate to Severe Crohn's Disease | Crohn's Disease;Colitis;Intestinal Disease;Gastrointestinal Disease;Digestive System Disease | Drug: anti-Interferon-gamma monoclonal antibody | Facet Biotech | NULL | Completed | 18 Years | 70 Years | Both | 175 | Phase 2 | United States;Canada |
| 2064 | NCT00446433 (ClinicalTrials.gov) | March 2002 | 7/3/2007 | A Study to Evaluate CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease | Crohn's Disease | Drug: CC-5013 | Celgene Corporation | NULL | Completed | 12 Years | 75 Years | Both | 90 | Phase 2 | United States;France;Israel;United Kingdom |
| 2065 | NCT00946946 (ClinicalTrials.gov) | February 2002 | 24/7/2009 | Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine | Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence | Crohn's Disease | Drug: Azathioprine;Drug: Mesalazine;Drug: Azathioprine placebo;Drug: Mesalazine placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 70 Years | Both | 78 | Phase 3 | Austria;Germany |
| 2066 | NCT00035503 (ClinicalTrials.gov) | January 31, 2002 | 3/5/2002 | Multicenter Trial For Patients With Acute Crohn's Disease | Crohn's Disease | Drug: etiprednol dicloacetate | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 18 Years | N/A | All | Phase 2 | United States;Canada | ||
| 2067 | NCT00510978 (ClinicalTrials.gov) | January 2002 | 2/8/2007 | Probiotics in GastroIntestinal Disorders | One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis | Ulcerative Colitis;Crohn's Disease | Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo | University College Cork | European Commission | Active, not recruiting | N/A | 75 Years | Both | 360 | Phase 2/Phase 3 | Ireland |
| 2068 | NCT00032799 (ClinicalTrials.gov) | December 2001 | 3/4/2002 | Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease | A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Completed | 18 Years | N/A | Both | 905 | Phase 3 | United States |
| 2069 | NCT00304252 (ClinicalTrials.gov) | November 2001 | 14/3/2006 | Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease | A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease | Crohn's Disease | Drug: Interferon beta-1a | EMD Serono | NULL | Terminated | 18 Years | N/A | Both | 192 | Phase 2 | Germany;Italy;Sweden;Switzerland;United Kingdom |
| 2070 | NCT00025805 (ClinicalTrials.gov) | October 23, 2001 | 25/10/2001 | G-CSF to Treat Crohn's Disease | Granulocyte-Colony Stimulating Factor Treatment for Crohn's Disease: A Pilot Study Assessing Immune and Clinical Response | Crohn's Disease | Drug: G-CSF | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | N/A | All | 23 | Phase 1 | United States |
| 2071 | NCT02209792 (ClinicalTrials.gov) | October 2001 | 5/8/2014 | Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's Disease | A Randomised, Double-blind, Placebo-controlled, Five* Parallel Groups, Dose Finding Study of BIRB 796 BS (10, 20, 30, and 60 mg*) Administered Twice a Day Orally Over 8 Weeks in Patients With Moderate to Severe Crohn's Disease Followed by a 18 Weeks Treatment Extension in Patients With Clinical Remission or Clinical Response After 8 Weeks Treatment With the Respective Dose of BIRB 796 BS - Extension Phase. * Subsequent to Amendment 4 (Dated 11 Jun 2002) a 60 mg b.i.d. Group Was Included. | Crohn Disease | Drug: Placebo;Drug: BIBR 796 BS, 5 mg;Drug: BIBR 796 BS, 20 mg | Boehringer Ingelheim | NULL | Terminated | 18 Years | 65 Years | Both | 284 | Phase 2 | NULL |
| 2072 | NCT00048113 (ClinicalTrials.gov) | September 2001 | 24/10/2002 | Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease | ISIS 2302-CS20, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease | Crohn's Disease | Drug: Alicaforsen | Isis Pharmaceuticals | NULL | Completed | 12 Years | N/A | Both | 150 | Phase 3 | United States;Canada |
| 2073 | NCT00554710 (ClinicalTrials.gov) | May 2001 | 6/11/2007 | Top Down Versus Step Up Strategies in Crohn's Disease | The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux | Crohn's Disease | Drug: infliximab+azathioprine;Drug: methylprednisolone or budesonide | Belgian IBD Research Group | Centocor BV;Schering-Plough | Completed | 16 Years | 75 Years | Both | 129 | Phase 4 | Belgium |
| 2074 | NCT00278577 (ClinicalTrials.gov) | April 2001 | 15/1/2006 | Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease | Immune Ablation and Hematopoietic Stem Cell Support in Patients With Severe Crohn's Disease | CROHN'S DISEASE | Biological: Immune Ablation and Hematopoietic Stem Cell Support | Richard Burt, MD | NULL | Terminated | N/A | 60 Years | Both | 25 | Phase 1 | United States |
| 2075 | NCT00007163 (ClinicalTrials.gov) | December 2000 | 9/12/2000 | Monoclonal Antibody Treatment of Crohn's Disease | A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Safety Study of Two Parallel Dose Levels of Subcutaneously Administered Human Monoclonal Antibody to Interleukin-12 (J695) in Patients With Active Crohn's Disease | Crohn's Disease | Drug: J695 | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | N/A | N/A | Both | 40 | Phase 1 | United States |
| 2076 | NCT00207662 (ClinicalTrials.gov) | July 2000 | 13/9/2005 | A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease | ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 580 | Phase 3 | NULL |
| 2077 | NCT00207766 (ClinicalTrials.gov) | June 2000 | 13/9/2005 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease | ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 306 | Phase 3 | NULL |
| 2078 | NCT00269386 (ClinicalTrials.gov) | April 2000 | 22/12/2005 | Clarithromycin in Active Crohn's Disease | Randomised Controlled Trial of Clarithromycin in Active Crohn's Disease | Crohn's Disease | Drug: Clarithromycin;Drug: Placebo | Royal Liverpool University Hospital | Abbott | Completed | 18 Years | N/A | Both | 44 | Phase 3 | United Kingdom |
| 2079 | NCT00655135 (ClinicalTrials.gov) | February 2000 | 3/4/2008 | Phase 2 Study of the Safety and Efficacy of LDP-02 in Mildly to Moderately Active Crohn's Patients | Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Determine the Safety, Pharmacokinetics, and Effectiveness of LDP-02 in Patients With Mildly to Moderately Active Crohn's Disease | Crohn's Disease | Drug: LDP-02;Drug: Placebo | Millennium Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 185 | Phase 2 | NULL |
| 2080 | NCT00004941 (ClinicalTrials.gov) | July 1996 | 24/2/2000 | Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease | Crohn's Disease | Drug: monoclonal antibody cA2 | FDA Office of Orphan Products Development | Centocor, Inc. | Completed | 18 Years | 65 Years | Both | 94 | Phase 3 | NULL | |
| 2081 | NCT00269841 (ClinicalTrials.gov) | May 1996 | 22/12/2005 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease | A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease | Crohn Disease | Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo | Centocor, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 94 | Phase 3 | NULL |
| 2082 | NCT00004423 (ClinicalTrials.gov) | December 1995 | 18/10/1999 | Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease | Crohn's Disease | Drug: -aminosalicylic acid | University of Vermont | NULL | Completed | 18 Years | 80 Years | Both | 80 | N/A | NULL | |
| 2083 | NCT00269854 (ClinicalTrials.gov) | June 1995 | 22/12/2005 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease | A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease | Crohn Disease | Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo | Centocor, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 108 | Phase 2/Phase 3 | NULL |
| 2084 | EUCTR2006-004814-41-Outside-EU/EEA (EUCTR) | 07/02/2012 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 184 | NULL | ||||
| 2085 | EUCTR2012-005226-29-NL (EUCTR) | 08/03/2013 | Antibiotic therapy for children with active Crohn's disease | Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease - AZCRO | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: azithromycin Trade Name: metronidazole Product Name: metronidazole | Wolfson Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | United States;Canada;Israel;Netherlands | ||||
| 2086 | EUCTR2014-004354-34-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease | A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 35 | Japan | ||||
| 2087 | EUCTR2015-001925-18-NO (EUCTR) | 27/01/2016 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn’s disease | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of subjects with active Crohn’s disease. - A randomized, double-blind, study to explore the efficacy and safety of GED-0301 in Crohn's disease | Active Crohn's disease MedDRA version: 18.1;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1064 | Phase 3 | United States;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden | |||
| 2088 | EUCTR2019-000176-41-DE (EUCTR) | 15/08/2019 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment | Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 Product Name: OPS-2071 Product Code: OPS-2071 INN or Proposed INN: OPS-2071 Other descriptive name: OPS-2071 | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Hungary;Canada;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 2089 | EUCTR2007-006494-90-Outside-EU/EEA (EUCTR) | 07/02/2012 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | NA | Female: yes Male: yes | 100 | Belgium;Canada;Czech Republic;Poland;United Kingdom;United States | ||||
| 2090 | EUCTR2014-004381-24-Outside-EU/EEA (EUCTR) | 02/03/2015 | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents | A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: Certolizumab Pegol | UCB Celltech | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | United States;Australia;Canada;New Zealand | |||
| 2091 | EUCTR2014-004560-38-Outside-EU/EEA (EUCTR) | 12/11/2014 | The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease. | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease. | Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbott Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 80 | Japan | ||||
| 2092 | EUCTR2017-000575-88-CZ (EUCTR) | 25/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Serbia;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Brazil;Poland;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand | |||
| 2093 | EUCTR2016-003191-50-NO (EUCTR) | 16/11/2017 | A Maintenance and Long-term Extension Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;New Zealand;Japan | |||
| 2094 | EUCTR2011-003742-40-DE (EUCTR) | 20/10/2011 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide INN or Proposed INN: BUDESONIDE | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 50 | Italy;Germany;Poland;Canada;United States | ||||
| 2095 | EUCTR2017-003649-10-PL (EUCTR) | 11/12/2017 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 INN or Proposed INN: ETROLIZUMAB Other descriptive name: ETROLIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Germany;Poland;Spain;Belgium;United States | |||
| 2096 | JPRN-JapicCTI-111460 | 29/03/2011 | Phase II Study of Z-206 in Patients with Active Crohn's Disease | Phase II Study of Z-206 in Patients with Active Crohn's Disease | Active Crohn's disease | Intervention name : Z-206 INN of the intervention : Mesalazine Dosage And administration of the intervention : oral | Zeria Pharmaceutical Co., Ltd. | Kyowa Hakko Kirin Co., Ltd. | 16 | 64 | BOTH | Phase 2 | NULL | |||
| 2097 | EUCTR2016-003190-17-PL (EUCTR) | 01/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease. | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 579 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden | |||
| 2098 | EUCTR2020-004301-31-PL (EUCTR) | 01/12/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 2099 | EUCTR2017-000574-11-PL (EUCTR) | 05/12/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | NA | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
| 2100 | EUCTR2014-004400-30-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42) | A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 46 | Japan | ||||
| 2101 | EUCTR2010-023589-39-HU (EUCTR) | 26/05/2011 | A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2) | A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent Crohn's Disease where oral ferrous preparations have failed or cannot be used (AEGIS 2) - ST10-021 for IDA in quiescent CD | Iron deficiency anaemia in quiescent Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ST10-021 Product Code: ST10-021 Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III) | Iron Therapeutics (Switzerland) AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Austria;Germany;United Kingdom | ||||
| 2102 | EUCTR2019-001866-14-GB (EUCTR) | 09/04/2020 | Open-label Extension Study of Brazikumab in Crohn’s Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 1000 | Phase 3 | United States;Czechia;Taiwan;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Hungary;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | |||
| 2103 | EUCTR2019-004225-24-PL (EUCTR) | 16/12/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Belgium;Poland;Russian Federation;Germany;United Kingdom;Japan | |||
| 2104 | EUCTR2017-000617-23-CZ (EUCTR) | 25/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | |||
| 2105 | EUCTR2006-002078-23-SK (EUCTR) | 11/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease | Moderate to severe Crohn´s Disease (Harvey Bradshaw index score greater or equal to 7) | Trade Name: HUMIRA | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 2106 | EUCTR2011-000854-44-NL (EUCTR) | 06/07/2011 | A clinical study for treatment of Crohns Disease with the new drugsubstance TRK-170. The study consists of two parts and are conductedat several hopsitals in Europe. Patients in the study may receive placebo(drug with no effect) but neither the doctor nor the patient will knowduring the study. | A Two Part, Multi Centre, Randomized, Placebo Controlled, Double BlindStudy of TRK 170 for the Treatment of Crohn's Disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TRK-170 Product Code: TRK-170 Product Name: TRK-170 Product Code: TRK-170 | Toray Industries Inc | NULL | Not Recruiting | Female: yes Male: yes | 609 | Czech Republic;Hungary;Poland;Bulgaria;Latvia;Norway;Netherlands;Sweden | ||||
| 2107 | EUCTR2016-000522-18-PL (EUCTR) | 04/04/2018 | Risk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy | Risk-stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira Product Name: HUMIRA INN or Proposed INN: ADALIMUMAB Trade Name: Azathioprine INN or Proposed INN: Azathioprine Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE | PIBDnet (Pediatric Inflammatory Bowel Disease Network) | NULL | NA | Female: no Male: no | 312 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Hungary;Czech Republic;Canada;Belgium;Poland;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 2108 | EUCTR2016-003123-32-NL (EUCTR) | 10/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 2109 | EUCTR2016-001956-22-FR (EUCTR) | 23/01/2017 | A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's Disease | A Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease | Moderately to severely active Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 1 | United States;France;Canada;Poland;Belgium;Germany | |||
| 2110 | EUCTR2017-000617-23-IE (EUCTR) | 10/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;United Kingdom;Austria;Lithuania;Turkey;Korea, Republic of;Bosnia and Herzegovina;Netherlands;South Africa;Australia;Italy;Switzerland;Colombia;Israel;Russian Federation;Lebanon;Ireland;Ukraine;Spain;Greece;Slovakia;Estonia;Portugal;Serbia;United States | |||
| 2111 | EUCTR2016-003123-32-PL (EUCTR) | 02/08/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 2112 | EUCTR2015-002882-41-AT (EUCTR) | 05/11/2015 | A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease | Sono-Response-StudyA Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease | Inflammatory bowel disease (Crohn's disease) MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: SonoVue Product Name: SonoVue INN or Proposed INN: sulphur hexafluoride Other descriptive name: SULFUR HEXAFLUORIDE | Medical University of Vienna (MUW) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | |||||
| 2113 | EUCTR2017-000575-88-PL (EUCTR) | 20/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn's Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whetherthey receive study drug or placebo) | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305) - CARMEN CD 305 | Crohn's disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | Serbia;United States;Czechia;Lithuania;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;Japan | |||
| 2114 | EUCTR2010-022383-12-DE (EUCTR) | 02/11/2010 | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease | Subjects with Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Portugal;United States;Estonia;Greece;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden | ||||
| 2115 | JPRN-JapicCTI-121765 | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | A Multicentre, Double-blind, Randomised, Parallel-group, Phase3 Study to Assess Efficacy and Safety of D9421-C 9mg Versus Mesalazine 3g in Patients With Active Crohn's Disease (CD) in Japan | Crohn's Disease | Intervention name : D9421-C Dosage And administration of the intervention : 9mg, Oral once daily Control intervention name : Mesalazine Dosage And administration of the control intervention : 1g, Oral three times a day | AstraZeneca | NULL | 15 | BOTH | Phase 3 | NULL | |||||
| 2116 | EUCTR2017-000576-29-IE (EUCTR) | 10/04/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(CARMEN CD 306). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306) - CARMEN CD 306 | Crohn’s disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1032 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of | |||
| 2117 | EUCTR2015-004121-13-Outside-EU/EEA (EUCTR) | 17/11/2015 | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie GK | NULL | NA | Female: yes Male: yes | 28 | Japan | ||||
| 2118 | EUCTR2018-004346-42-PL (EUCTR) | 01/08/2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease | A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease - 52-Week Phase 2b/3 Crohn’s Disease Study | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598 Trade Name: Humira® INN or Proposed INN: ADALIMUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 2000 | Phase 2;Phase 3 | United States;Czechia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;South Africa;Bulgaria;Germany | |||
| 2119 | EUCTR2014-004132-20-Outside-EU/EEA (EUCTR) | 28/07/2016 | Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan | A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan | Active Crohn’s Disease MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Entocort Product Code: D9421-C INN or Proposed INN: budesonide Trade Name: Pentasa INN or Proposed INN: mesalazine | AstraZeneca K.K. | NULL | NA | Female: yes Male: yes | 112 | Phase 3 | Japan | |||
| 2120 | EUCTR2010-022382-10-NO (EUCTR) | 23/11/2010 | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | A Randomised, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to Severely Active Crohn’s Disease | Subjects with Moderately-to-Severely Active Crohn’s Disease MedDRA version: 12.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Product Name: GSK1605786A Product Code: GSK1605786A Other descriptive name: N-{4-Chloro-2-[(1-oxido-4-pyridinyl)carbonyl]phenyl}-4-(1,1-dimethylethyl)benzenesulfonamide, sodium | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Spain;Austria;United Kingdom;Italy;Czech Republic;Hungary;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 2121 | EUCTR2014-004399-42-Outside-EU/EEA (EUCTR) | 05/03/2015 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | Japan | |||
| 2122 | EUCTR2016-003123-32-NO (EUCTR) | 16/11/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 2123 | EUCTR2017-002231-41-FR (EUCTR) | 15/12/2017 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Hungary;Canada;Poland;Belgium;Ukraine;Israel;Netherlands;Germany;United Kingdom | |||
| 2124 | EUCTR2017-004295-55-CZ (EUCTR) | 05/02/2018 | Multicenter Extension Study of Oral Ozanimod in patients with Moderately to Severely Active Crohn’s Disease | A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 1200 | Phase 3 | Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Italy;France;Puerto Rico;Denmark;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Turkey;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Saudi Arabia;Spain;Ireland;Israel;Russian Federation;Switzerland;Australia;South Africa;Netherlands;China;Czechia;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Argentina;Belgium;Poland;Singapore;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | |||
| 2125 | EUCTR2014-004531-39-Outside-EU/EEA (EUCTR) | 12/11/2014 | A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease. | A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease. | Crohn's Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbott Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 80 | Japan | ||||
| 2126 | EUCTR2016-003123-32-CZ (EUCTR) | 19/07/2017 | A Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 855 | Phase 3 | Bulgaria;Germany;Norway;Japan;New Zealand;Belarus;Portugal;Hong Kong;Taiwan;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Bosnia and Herzegovina;Korea, Republic of;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;Serbia;United States;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore | |||
| 2127 | EUCTR2017-000617-23-PL (EUCTR) | 20/06/2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Crohn’s Disease, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo. | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as MaintenanceTherapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 307) - CARMEN CD 307 | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab Product Name: SHP647 Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 983 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan | |||
| 2128 | EUCTR2020-004301-31-BE (EUCTR) | 26/01/2022 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 2129 | EUCTR2010-019996-32-NL (EUCTR) | 27/07/2011 | A clinical trial to evaluate whether Neovacs' TNFa-Kinoid is effective and safe for treating adult subjects with moderate to severe Crohn's Disease | A phase II, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety and immunogenicity of Neovacs’ TNFa-Kinoid in adult subjects with Crohn’s Disease - TNF-K-005 | Moderate to severe Crohn’s Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TNF-Kinoid Product Code: TNF-K INN or Proposed INN: Not assigned yet | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 2 | France;Hungary;Czech Republic;Belgium;Croatia;Romania;Bulgaria;Germany;Netherlands | |||
| 2130 | JPRN-JapicCTI-080566 | 09/04/2008 | A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease | Crohn's Disease | Intervention name : Budesonide Dosage And administration of the intervention : Oral | AstraZeneca | NULL | 18 | 65 | BOTH | Phase 2 | NULL | |||
| 2131 | EUCTR2019-004225-24-GB (EUCTR) | 25/11/2020 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 90 | Phase 3 | United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom | |||
| 2132 | EUCTR2020-004301-31-CZ (EUCTR) | 28/04/2021 | A study to evaluate efficacy and safety of Vedolizumab in pediatric subjects with moderately to severely active Crohn's disease | A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy | Moderately to severely active Crohn’s disease (CD) MedDRA version: 20.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: Vedolizumab INN or Proposed INN: Vedolizumab Other descriptive name: MLN0002 | Takeda Development Center Americas, Inc. | NULL | NA | Female: yes Male: yes | 120 | Phase 3 | United States;Czechia;Slovakia;Greece;Spain;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Croatia;Australia;China;Japan;Korea, Republic of | |||
| 2133 | EUCTR2017-000574-11-CZ (EUCTR) | 01/11/2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab | Shire Human Genetic Therapies, Inc. | NULL | NA | Female: yes Male: yes | 2453 | Phase 3 | United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand;Japan | |||
| 2134 | EUCTR2017-004293-33-DE (EUCTR) | 06/02/2018 | Multicenter Study of Oral Ozanimod as Induction Therapy in patients with Moderately to Severely Active Crohn’s Disease | Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease | Moderately to Severely Active Crohn’s Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD Product Name: ozanimod Product Code: RPC1063 (equivalent to ozanimod HCl) INN or Proposed INN: Ozanimod Other descriptive name: OZANIMOD | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 600 | Phase 3 | Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Poland;Singapore;Georgia;Bulgaria;Germany;Sweden;United States;Portugal;Serbia;Hong Kong;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;France;Australia;South Africa | |||
| 2135 | EUCTR2020-004457-76-FR (EUCTR) | 27/08/2021 | A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions. | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED | Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Belgium;Poland;Germany;Japan | |||
| 2136 | EUCTR2015-001924-40-PL (EUCTR) | 29/03/2017 | A study to evaluate the drug Mongersen (GED-0301) for the treatment of Crohn's disease in adults and adolescents. | A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease - A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease | Active Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10021315;Term: Ileitis terminal;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen Product Name: Mongersen Product Code: GED-0301 INN or Proposed INN: mongersen | Celgene Corporation | NULL | Not Recruiting | Female: yes Male: yes | 798 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;Netherlands;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Norway;Germany;Sweden | |||
| 2137 | EUCTR2011-003743-22-DE (EUCTR) | 20/10/2011 | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive | Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Entocort® Kapseln Product Name: budesonide INN or Proposed INN: budesonide | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 110 | United States;Canada;Poland;Germany;Italy | ||||
| 2138 | EUCTR2019-004225-24-Outside-EU/EEA (EUCTR) | 08/02/2021 | A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease | A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: USTEKINUMAB | Janssen-Cilag International NV | NULL | NA | Female: yes Male: yes | Phase 3 | Japan;Russian Federation;United States;Belgium;Germany;Hungary;Poland;United Kingdom | ||||
| 2139 | EUCTR2016-003191-50-PL (EUCTR) | 03/08/2017 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 1250 | Phase 3 | Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Ukraine;Chile;Italy;France;Puerto Rico;Denmark;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;Canada;Brazil;Croatia;Romania;Sweden;United States;Serbia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Bulgaria;Germany;Norway;New Zealand;Japan |