96. クローン病 Crohn disease Clinical trials / Disease details
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 | 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 |
| 2 | 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 | ||
| 3 | NCT05239702 (ClinicalTrials.gov) | February 28, 2022 | 1/12/2021 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases | Crohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune Diseases | Biological: CD7 CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 4 | 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 |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 |
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 |
| 16 | NCT04626947 (ClinicalTrials.gov) | October 30, 2021 | 29/9/2020 | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease;C. Diff. Infections | Biological: Bezlotoxumab | David Binion, MD | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | United States |
| 17 | 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 |
| 18 | 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 | ||
| 19 | EUCTR2021-000469-33-NL (EUCTR) | 12/10/2021 | 25/03/2021 | Scientific medical research comparing the effectiveness of Infliximab by injection in the abdominal tissiue (subcutaneous) monotherapy and infliximab subcutaneous injection with anti-inflammatory drugs in the treatment of moderate to severe chronic inflammatory bowel disease. | A Prospective Multicenter Randomized Controlled, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn’s Disease. - DIRECT CD | Crohns disease;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | Trade Name: Remsima Product Name: Remsima Product Code: EMEA/H/C/002576 Trade Name: Puri Nethol Product Name: Puri Nethol Product Code: RVG00859 Trade Name: Imuran Product Name: Imuran Trade Name: Thiosix Product Name: Thiosix Product Code: RVG 114681 Trade Name: Ebetrex 15 mg = 0,75 ml, oplossing voor injectie in voorgevulde injectiespuit 20 mg/ml Product Name: Ebetrex Product Code: RVG 116648 | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3;Phase 4 | Netherlands | ||
| 20 | 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 |
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 |
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | EUCTR2017-000725-12-DK (EUCTR) | 07/04/2021 | 14/10/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: Darvadstrocel Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 30 | EUCTR2017-000725-12-SE (EUCTR) | 30/03/2021 | 20/08/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 31 | 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 |
| 32 | 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 | ||
| 33 | EUCTR2018-005086-39-BG (EUCTR) | 27/10/2020 | 25/06/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;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] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina | ||
| 34 | 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 |
| 35 | ChiCTR2000037094 | 2020-09-01 | 2020-08-26 | Discovery and detection of a novel antigen for Crohn’s disease (CD) | Discovery and detection of a novel antigen for Crohn’s disease (CD) | Inflammatory Bowel Disease | Gold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA; | The First Affiliated Hospital of Anhui Medical University | NULL | Completed | 18 | 80 | Both | Target condition:100;Difficult condition:100 | China | |
| 36 | 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 | |
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | EUCTR2019-001337-13-FR (EUCTR) | 18/03/2020 | 02/03/2020 | USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study | USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP | patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: STELARA Trade Name: STELARA 90 mg solution for injection in pre-filled syringe | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 4 | France | ||
| 40 | 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 | |||
| 41 | 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 |
| 42 | EUCTR2018-005086-39-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;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] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 43 | 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 | ||
| 44 | 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 |
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | EUCTR2018-005086-39-HU (EUCTR) | 28/10/2019 | 08/04/2019 | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;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] | Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 48 | EUCTR2018-005086-39-PL (EUCTR) | 07/10/2019 | 06/05/2019 | A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;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] | Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 | Landos Biopharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Bulgaria;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | EUCTR2017-000725-12-DE (EUCTR) | 17/07/2019 | 28/02/2019 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 52 | 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 | ||
| 53 | 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 | |
| 54 | 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 | ||
| 55 | 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 | ||
| 56 | 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 | ||
| 57 | 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 | ||
| 58 | 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 |
| 59 | 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 | ||
| 60 | EUCTR2017-000725-12-GB (EUCTR) | 17/04/2019 | 22/10/2018 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 | ||
| 65 | 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 | ||
| 66 | 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 | ||
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 |
| 76 | 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 | ||
| 77 | 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 | ||
| 78 | 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 |
| 79 | 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 | ||
| 80 | 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 | ||
| 81 | 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 | ||
| 82 | 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 | ||
| 83 | 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 | ||
| 84 | 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 | ||
| 85 | 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 | ||
| 86 | 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 | ||
| 87 | 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 | ||
| 88 | 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 | ||
| 89 | 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 | ||
| 90 | 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 | ||
| 91 | 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 | ||
| 92 | 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 | ||
| 93 | 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 | ||
| 94 | 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 | ||
| 95 | 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 | ||
| 96 | 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 | ||
| 97 | 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 | ||
| 98 | 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 | ||
| 99 | 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 | ||
| 100 | 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 | ||
| 101 | 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 | ||
| 102 | 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 | ||
| 103 | 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 | ||
| 104 | 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 | ||
| 105 | 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 | ||
| 106 | 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 | ||
| 107 | 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 | ||
| 108 | 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 | ||
| 109 | 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 | ||
| 110 | 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 | ||
| 111 | 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 | ||
| 112 | 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 | ||
| 113 | 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 | ||
| 114 | 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 | ||
| 115 | 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 | ||
| 116 | 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 | |
| 117 | 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 | ||
| 118 | 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 | ||
| 119 | 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 | ||
| 120 | 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 |
| 121 | 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 | ||
| 122 | 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 | ||
| 123 | 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 | ||
| 124 | 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 | ||
| 125 | 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 | ||
| 126 | 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 | ||
| 127 | 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 | ||
| 128 | 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 | ||
| 129 | 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 | ||
| 130 | 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 | ||
| 131 | 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 | ||
| 132 | 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 | ||
| 133 | 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 | ||
| 134 | 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 | ||
| 135 | 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 | ||
| 136 | 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 | ||
| 137 | 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 | ||
| 138 | 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 | ||
| 139 | 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 | ||
| 140 | 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 | ||
| 141 | 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 | ||
| 142 | 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 |
| 143 | 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 | ||
| 144 | 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 | ||
| 145 | 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 | ||
| 146 | 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 | ||
| 147 | 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 | ||
| 148 | 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 |
| 149 | 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 | ||
| 150 | 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 | ||
| 151 | 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 | ||
| 152 | 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 | ||
| 153 | 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 | ||
| 154 | 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 | ||
| 155 | 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 | ||
| 156 | 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 | ||
| 157 | 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 | ||
| 158 | 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 | ||
| 159 | 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 | ||
| 160 | 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 | ||
| 161 | 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 | ||
| 162 | 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 | ||
| 163 | 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 | ||
| 164 | 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 | ||
| 165 | 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 | ||
| 166 | 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 | ||
| 167 | 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 | ||
| 168 | 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 | ||
| 169 | 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 | ||
| 170 | 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 | ||
| 171 | 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 | ||
| 172 | 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 | ||
| 173 | 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 | ||
| 174 | 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 | ||
| 175 | 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 | ||
| 176 | 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 | ||
| 177 | 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 | ||
| 178 | 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 | ||
| 179 | 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 | ||
| 180 | 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 | ||
| 181 | JPRN-UMIN000031839 | 2018/04/01 | 01/04/2018 | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis | Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients | Crohn's disease | At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week. | Osaka University Graduate School of MedicineDepartment of Gastroenterology and Hepatology | Japan Community Health care Organizationi Osaka Hospital, Gastroenterology and HepatologyNational Hospital Organization Osaka National Hospital, Gastroenterology and HepatologyOsaka Rosai Hospital , Gastroenterology and HepatologyKansai Rosai Hospital, Gastroenterology and HepatologyItami City Hospital, Gastroenterology and HepatologyHyogo Prefectural Nishinomiya Hospital, Gastroenterology and HepatologyNishinomiya Municipal central hospital, Gastroenterology and Hepatology | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not selected | Japan |
| 182 | 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 | ||
| 183 | 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 | ||
| 184 | 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 | ||
| 185 | 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 | ||
| 186 | 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 | ||
| 187 | 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 | ||
| 188 | 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 | ||
| 189 | 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 | ||
| 190 | 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 | ||
| 191 | 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 | ||
| 192 | 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 | |
| 193 | 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 | ||
| 194 | EUCTR2017-000725-12-IT (EUCTR) | 08/01/2018 | 09/11/2020 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. - - | 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] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: [Cx601] | TIGENIX S.A.U | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Germany | ||
| 195 | EUCTR2017-000725-12-FR (EUCTR) | 16/11/2017 | 25/11/2019 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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] | Product Name: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 196 | 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 |
| 197 | EUCTR2016-001367-36-NL (EUCTR) | 06/11/2017 | 14/08/2017 | 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 | 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 | 1320 | 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 | ||
| 198 | 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 | ||
| 199 | 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 |
| 200 | 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 | ||
| 201 | 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 |
| 202 | EUCTR2017-000725-12-BE (EUCTR) | 12/09/2017 | 01/06/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 203 | EUCTR2017-000725-12-HU (EUCTR) | 07/09/2017 | 10/07/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 204 | EUCTR2017-000725-12-PL (EUCTR) | 03/09/2017 | 28/07/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | ||
| 205 | EUCTR2017-000725-12-CZ (EUCTR) | 08/08/2017 | 26/04/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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: Allogenic eASCs 5 million cells/ml suspension for injection CX601 Product Code: Cx601 INN or Proposed INN: nap Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 554 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Sweden | ||
| 206 | 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 | ||
| 207 | EUCTR2017-000725-12-ES (EUCTR) | 26/07/2017 | 06/06/2017 | A clinical research study of an investigational new drug to treat perianal fistulas in patients 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. ADMIRE-CD II study. | 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] | Product Name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue Product Code: Cx601 INN or Proposed INN: To be determined Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 326 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Israel;Germany;United Kingdom;Italy | ||
| 208 | 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 |
| 209 | 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 | ||
| 210 | EUCTR2016-001367-36-HR (EUCTR) | 26/06/2017 | 12/09/2017 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 1320 | 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 | ||
| 211 | 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 |
| 212 | 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 |
| 213 | NCT03393247 (ClinicalTrials.gov) | June 1, 2017 | 8/7/2017 | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD | The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study | Crohn Disease | Drug: infliximab and azathioprine combination at week 0;Drug: infliximab and azathioprine combination at week 14 | Sixth Affiliated Hospital, Sun Yat-sen University | NULL | Unknown status | 14 Years | 60 Years | All | 160 | N/A | China |
| 214 | EUCTR2016-001367-36-NO (EUCTR) | 31/05/2017 | 09/11/2017 | 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 | 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 | 1320 | 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;Germany;Norway;Iceland;New Zealand;Japan;Sweden | ||
| 215 | EUCTR2016-001367-36-SE (EUCTR) | 24/05/2017 | 27/12/2016 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;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;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland | ||
| 216 | 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 | ||
| 217 | EUCTR2016-001367-36-IS (EUCTR) | 09/05/2017 | 27/12/2016 | 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 | 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 | 1320 | Phase 3 | Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden;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 | ||
| 218 | 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 | ||
| 219 | 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 | ||
| 220 | EUCTR2016-001367-36-GR (EUCTR) | 31/03/2017 | 03/01/2017 | 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 | 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 | 1320 | 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 | ||
| 221 | 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 | ||
| 222 | EUCTR2016-001367-36-BE (EUCTR) | 31/03/2017 | 08/08/2017 | 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 | 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 | 1320 | 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;Hong Kong;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;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 223 | 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 | |
| 224 | EUCTR2016-001367-36-DE (EUCTR) | 27/03/2017 | 27/12/2016 | 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 | 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 | 1320 | Phase 3 | 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;Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia | ||
| 225 | 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 | ||
| 226 | EUCTR2016-001367-36-BG (EUCTR) | 23/03/2017 | 12/12/2016 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden | ||
| 227 | 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 | ||
| 228 | EUCTR2016-001367-36-PT (EUCTR) | 13/03/2017 | 05/01/2017 | 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 | 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 | 1320 | Phase 3 | United States;Belarus;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;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Iceland;Germany;New Zealand;Japan;Sweden | ||
| 229 | 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 | ||
| 230 | JPRN-UMIN000026330 | 2017/02/27 | 28/02/2017 | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease | Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease - Efficacy and safety of IFX-BS in CD patients | Crohn disease | Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months) | University of Toyama | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 231 | EUCTR2016-001367-36-SK (EUCTR) | 16/02/2017 | 12/01/2017 | 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 | 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 | 1320 | Phase 3 | United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Iceland;Germany;Norway;New Zealand;Japan;Sweden | ||
| 232 | 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 | ||
| 233 | 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 | ||
| 234 | EUCTR2016-001367-36-CZ (EUCTR) | 08/02/2017 | 16/12/2016 | 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 | 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 | 1320 | 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;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden | ||
| 235 | EUCTR2016-001367-36-HU (EUCTR) | 08/02/2017 | 08/12/2016 | 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 | 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 | 1320 | 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 | ||
| 236 | 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 | ||
| 237 | 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 | ||
| 238 | EUCTR2016-001367-36-AT (EUCTR) | 31/01/2017 | 15/12/2016 | 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 | 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 | Not Recruiting | Female: yes Male: yes | 1320 | 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 | ||
| 239 | 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 | ||
| 240 | EUCTR2016-001367-36-ES (EUCTR) | 31/01/2017 | 01/02/2017 | 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 | 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 | 1320 | 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 | ||
| 241 | 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 | ||
| 242 | EUCTR2016-001367-36-GB (EUCTR) | 04/01/2017 | 19/12/2016 | 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 | 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 | 1320 | 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 | ||
| 243 | 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 | ||
| 244 | 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 |
| 245 | NCT03183661 (ClinicalTrials.gov) | November 16, 2016 | 8/6/2017 | A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical Trial | Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101) | Crohn Disease | Biological: ALLO-ASC-CD | Anterogen Co., Ltd. | NULL | Enrolling by invitation | 18 Years | 65 Years | All | 9 | N/A | NULL |
| 246 | 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 | ||
| 247 | EUCTR2016-003073-18-GB (EUCTR) | 29/09/2016 | 16/09/2016 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders 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] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration INN or Proposed INN: Ozanimod hydrochloride | Celgene International II Sàrl | NULL | Not Recruiting | Female: no Male: yes | 6 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 248 | EUCTR2014-004904-31-BE (EUCTR) | 21/09/2016 | 29/07/2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | ||
| 249 | NCT02820493 (ClinicalTrials.gov) | September 2016 | 17/5/2016 | Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF | Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression | Crohn Disease | Drug: vedolizumab | Universita degli Studi di Genova | NULL | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 4 | NULL |
| 250 | 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 | ||
| 251 | 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 | ||
| 252 | 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 | ||
| 253 | 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 |
| 254 | 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 |
| 255 | 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 |
| 256 | EUCTR2015-003270-32-IT (EUCTR) | 09/02/2016 | 20/03/2019 | Identification of cells predicting response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis and Crohn’s disease | Identification of circulating and tissutal T cell subsets to predict clinical and endoscopical response to Entyvio® (vedolizumab) in patients with Ulcerative Colitis (UC) and Crohn’s disease (CD) - Immunological predictors of therapeutic response to vedolizumab | Ulcerative colitis (UC) and Crohn disease (CD) 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] | Trade Name: ENTYVIO - 300 MG - POLVERE PE RCONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) (20ML) - 1 FLACONCINO Product Name: entyvio INN or Proposed INN: VEDOLIZUMAB | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 4 | Italy | ||
| 257 | 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 | ||
| 258 | 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 |
| 259 | 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 |
| 260 | 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 |
| 261 | 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 | ||||
| 262 | 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 |
| 263 | 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 | ||
| 264 | 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 | ||
| 265 | EUCTR2014-004904-31-NL (EUCTR) | 19/05/2015 | 26/01/2015 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) | Mundipharma Pharmaceuticals B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Netherlands | |||
| 266 | 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 |
| 267 | 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 |
| 268 | JPRN-UMIN000032485 | 2015/01/01 | 08/05/2018 | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease - postoperative early adalimumab or immunomodulator in CD study | Cron's disease | adalimumab azathiopurine | Sakura medical center, Toho university | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 20 | Not selected | Japan |
| 269 | 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 |
| 270 | JPRN-UMIN000015770 | 2014/09/01 | 01/12/2014 | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. | Randomized double-blind multicenter study for anti-inflammatory effects of highly bioavailable curcumin on Crohn's disease. - Exploratory study for effects of highly bioavailable curcumin on Crohn's disease. | Crohn's disease (180 <= CDAI < 450)CDAI: Crohn's disease Activity Index | Standard therapy for Crohn's disease (Pentasa 3 g/day) Patients take curcumin or placebo | Hamamatsu South Hospital, Centre for Gastroenterology and Inflammatory Bowel Disease Research | NULL | Complete: follow-up complete | 20years-old | 70years-old | Male and Female | 30 | Not selected | Japan |
| 271 | 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 |
| 272 | 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 | |||
| 273 | 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 | ||
| 274 | 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 | |||
| 275 | 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 | |||
| 276 | 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 |
| 277 | 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 |
| 278 | 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 | |||
| 279 | 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 | |
| 280 | 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 |
| 281 | EUCTR2011-006064-43-DE (EUCTR) | 27/09/2012 | 17/02/2012 | 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 allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s disease MedDRA version: 17.1;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 million cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix S.A.U. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 282 | 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 | ||
| 283 | 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 | ||
| 284 | 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 | ||
| 285 | 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 |
| 286 | 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 |
| 287 | EUCTR2011-006064-43-BE (EUCTR) | 22/06/2012 | 21/02/2012 | 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 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s desease MedDRA version: 19.0;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: N/A Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A. Unipersonal | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Italy | ||
| 288 | EUCTR2011-006064-43-AT (EUCTR) | 15/05/2012 | 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 allogeneicadipose-derived stem cells (eASCs) for the treatment of perianal fistulisingCrohn's disease over a period of 24 weeks and an extended follow-upperiod up to 104 weeks. ADMIRE-CD study. | Perianal fistulising Crohn´s disease MedDRA version: 19.0;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 cells/ml suspension for injection. CX601 Product Code: Cx601 INN or Proposed INN: Not applicable Other descriptive name: Expanded human allogenic mesenchymal adult stem cells extracted from adipose tissue (eASCs) | TiGenix, S.A.U. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Belgium;Spain;Austria;Israel;Netherlands;Germany;Italy | ||
| 289 | 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 | |||
| 290 | 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 | |||
| 291 | 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 |
| 292 | 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 | |||
| 293 | JPRN-UMIN000013534 | 2012/03/01 | 28/03/2014 | The elucidation of the action mechanism on the effectiveness of propagermanium for Crohn's disease | Crohn's disease | 1.To collect approximately 20ml of peripheral blood from CD patients who are under medical examination and treatment in Hyogo College of Medicine. 2.To be provided approximately 30g of intestinal specimen from the patients with CD who undergoes intestinal resection in Hyogo College of Medicine. | Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine | Sanwa Kagaku Kenkyusho Co,, Ltd. | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 294 | 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 | |||
| 295 | 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 |
| 296 | 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 | |||
| 297 | 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 | |||
| 298 | 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 | ||
| 299 | 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 | |||
| 300 | 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 | ||
| 301 | 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 | |||
| 302 | JPRN-UMIN000005946 | 2011/07/01 | 07/07/2011 | Efficacy and safety of endoscopic balloon dilation for small bowel strictures of patients with CD | Crohn's disease | Endoscopic balloon dilation using balloon assisted enteroscopy are performed for eligible small bowel stricture of patients with CD. | Fukuoka University Chikushi Hospital | NULL | Complete: follow-up continuing | 15years-old | 75years-old | Male and Female | 100 | Not selected | Japan | |
| 303 | 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 | |||
| 304 | JPRN-UMIN000005251 | 2011/06/01 | 01/06/2011 | A prospective open-label study to investigate the efficacy and safety of methotrexate in Crohn's disease patients who lost response or showed intolerance to infliximab | Crohn's disease | Administration of oral methotrexate 15mg divided after breakfast and dinner weekly for 16 weeks.If remission(CDAI<150) cannot be obtained at week 8, the dose of methotrexate can be increased to 25mg weekly. | Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 14 | Not selected | Japan | |
| 305 | 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 | |||
| 306 | 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 |
| 307 | 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 | |||
| 308 | 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 | ||
| 309 | 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 | |||
| 310 | 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 | ||
| 311 | 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 | |||
| 312 | 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 | ||||
| 313 | 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 | |||
| 314 | 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 | |||
| 315 | 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 | |||
| 316 | 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 | ||||
| 317 | 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 | |||
| 318 | 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 | |||
| 319 | 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 | ||
| 320 | 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 | |||
| 321 | 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 | ||
| 322 | 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 | ||
| 323 | 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 |
| 324 | 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 | |||
| 325 | 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 | ||
| 326 | 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 | ||
| 327 | 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 | ||
| 328 | 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 | ||
| 329 | 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 | ||
| 330 | 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 | ||
| 331 | 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 | ||
| 332 | 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 |
| 333 | 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 | ||
| 334 | 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 | ||
| 335 | 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 | ||
| 336 | 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 | ||
| 337 | 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 | ||
| 338 | 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 |
| 339 | 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 | ||
| 340 | 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 | ||
| 341 | 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 | |||
| 342 | 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 | ||
| 343 | 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 | ||
| 344 | 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 | ||
| 345 | 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 | ||
| 346 | 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 | ||
| 347 | 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 | ||
| 348 | 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 | ||
| 349 | 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 | ||
| 350 | EUCTR2005-003827-38-AT (EUCTR) | 15/10/2007 | 15/10/2007 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 351 | EUCTR2005-003827-38-FR (EUCTR) | 20/09/2007 | 23/07/2007 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Bulgaria;France;Austria;Sweden | |||
| 352 | EUCTR2005-003827-38-BE (EUCTR) | 19/09/2007 | 26/07/2007 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Denmark;Belgium;France;Bulgaria;Austria;Sweden | |||
| 353 | EUCTR2005-003827-38-SE (EUCTR) | 19/09/2007 | 11/07/2007 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 354 | 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 | ||
| 355 | 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 | ||
| 356 | 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 | |||
| 357 | 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 | ||
| 358 | 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 | ||
| 359 | 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 | |||
| 360 | 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 | |||
| 361 | 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 | |||
| 362 | 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 | |||
| 363 | 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 | ||
| 364 | 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 | ||
| 365 | 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 | ||
| 366 | EUCTR2005-003827-38-DE (EUCTR) | 15/03/2007 | 14/12/2006 | 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden | |||
| 367 | EUCTR2005-003827-38-HU (EUCTR) | 13/03/2007 | 22/12/2006 | 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 423 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 368 | 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 | ||
| 369 | 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 | |||
| 370 | 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 | ||
| 371 | 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 | ||
| 372 | 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 | |||
| 373 | 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 | ||
| 374 | EUCTR2004-001213-34-GB (EUCTR) | 30/01/2007 | 19/08/2008 | 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 - Oral budesonide vs. oral mesalazine in active 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 - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | Trade Name: Salofalk INN or Proposed INN: mesalazine Other descriptive name: 5-Aminosalicyl acid Trade Name: Budenofalk INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Czech Republic;United Kingdom | |||
| 375 | 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 | |||
| 376 | EUCTR2006-002027-16-GR (EUCTR) | 12/12/2006 | 05/09/2006 | Certolizumab pegol 400 mg monthly 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 the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. | Certolizumab pegol 400 mg monthly 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 the response or have developed intolerance to infliximab: an open-label, multi-center, single-cohort study to evaluate efficacy, safety and onset of action. | 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 the response or have developed intolerance to infliximab | Product Name: certolizumab pegol Product Code: CDP870 | UCB AE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Greece | ||||
| 377 | 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 |
| 378 | 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 | ||
| 379 | 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 | |||
| 380 | 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 |
| 381 | 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 | ||
| 382 | 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 |
| 383 | 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 | ||
| 384 | 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 | ||
| 385 | 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 | ||
| 386 | 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 | ||
| 387 | 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 | ||
| 388 | EUCTR2005-003827-38-GB (EUCTR) | 02/05/2006 | 18/11/2005 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 598 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Belgium;Austria;Denmark;Bulgaria;Germany;United Kingdom;Sweden | ||
| 389 | 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 |
| 390 | 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 |
| 391 | 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 | ||
| 392 | 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 |
| 393 | EUCTR2005-003827-38-DK (EUCTR) | 27/02/2006 | 07/12/2005 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 598 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 394 | EUCTR2005-003827-38-CZ (EUCTR) | 20/02/2006 | 15/12/2005 | 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 or large 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. | Product Name: CCX282-B Product Code: CCX282-B | ChemoCentryx, Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Hungary;United Kingdom;Czech Republic;Belgium;Denmark;France;Bulgaria;Austria;Sweden | |||
| 395 | 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 |
| 396 | 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 |
| 397 | 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 |
| 398 | EUCTR2004-004387-72-AT (EUCTR) | 11/10/2005 | 09/06/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Austria;Germany | ||
| 399 | EUCTR2004-004387-72-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease. - N/A | Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 400 | EUCTR2004-004388-31-DE (EUCTR) | 03/06/2005 | 07/01/2005 | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease - N/A | Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD). MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Product Name: Visilizumab Product Code: HuM291 INN or Proposed INN: Visilizumab Other descriptive name: Anti-CD3 Monoclonal antibody | PDL BioPharma, Inc | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 401 | 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 |
| 402 | EUCTR2004-002693-37-DE (EUCTR) | 14/03/2005 | 06/01/2005 | 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 - CD-2 | 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 - CD-2 | Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents MedDRA version: 7.1;Level: LLT;Classification code 10011401 | Trade Name: UVADEX INN or Proposed INN: methoxsalen | Therakos | NULL | Not Recruiting | Female: yes Male: yes | 25 | Germany | |||
| 403 | 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 | ||
| 404 | EUCTR2004-001213-34-SK (EUCTR) | 16/12/2004 | 16/08/2005 | 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 - Oral budesonide vs. oral mesalazine in active 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 - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | Phase 3 | Czech Republic;Slovakia;United Kingdom | ||
| 405 | EUCTR2004-001213-34-CZ (EUCTR) | 02/11/2004 | 02/11/2004 | 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 - Oral budesonide vs. oral mesalazine in active 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 - Oral budesonide vs. oral mesalazine in active CD | moderately active Crohn’s disease (200 < CDAI < 400) MedDRA version: 7.0;Level: PT;Classification code 10011401 | INN or Proposed INN: mesalazine INN or Proposed INN: budesonide | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 370 | United Kingdom;Czech Republic | |||
| 406 | 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 |
| 407 | 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 |
| 408 | 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 |
| 409 | 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 |
| 410 | 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 |
| 411 | 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 |
| 412 | 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 |
| 413 | 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 | |||
| 414 | 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 | |||
| 415 | 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 | |||
| 416 | 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 | ||||
| 417 | 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 | |||
| 418 | 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 | |||
| 419 | 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 | |||
| 420 | 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 | |||
| 421 | 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 | |||
| 422 | 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 | |||
| 423 | 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 | ||||
| 424 | 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 | |||
| 425 | 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 | |||
| 426 | 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 | |||||
| 427 | 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 | ||||
| 428 | 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 |