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 | EUCTR2020-001811-26-BE (EUCTR) | 18/11/2021 | 22/07/2021 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 148 | Phase 4 | Belgium;Netherlands | ||
| 2 | NCT03712826 (ClinicalTrials.gov) | October 2021 | 16/8/2018 | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease | Crohn Disease | Drug: Anti-TNF Drug;Drug: Ustekinumab | Hospices Civils de Lyon | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | N/A | France |
| 3 | NCT04997733 (ClinicalTrials.gov) | September 22, 2021 | 5/7/2021 | Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal | Crohn Disease | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation (placebo) | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 74 Years | All | 150 | Phase 3 | France |
| 4 | EUCTR2020-002674-26-DE (EUCTR) | 19/05/2021 | 17/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 5 | NCT04646187 (ClinicalTrials.gov) | March 11, 2021 | 20/11/2020 | De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease | De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring | Inflammatory Bowel Diseases;Crohn Disease;Colitis, Ulcerative | Biological: Infliximab;Biological: Adalimumab | University Medical Center Groningen | European Crohn´s and Colitis Organisation;Bühlmann Laboratories AG | Recruiting | 12 Years | 25 Years | All | 148 | Phase 4 | Belgium;Netherlands;Spain |
| 6 | EUCTR2020-002674-26-SK (EUCTR) | 14/01/2021 | 20/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 7 | EUCTR2020-002674-26-CZ (EUCTR) | 13/01/2021 | 18/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 8 | EUCTR2020-002674-26-HU (EUCTR) | 06/01/2021 | 20/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 9 | EUCTR2020-002674-26-IT (EUCTR) | 10/12/2020 | 21/05/2021 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. - NA | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: [ABBV-066] INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: [Ustekinumab] INN or Proposed INN: USTEKINUMAB | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 10 | EUCTR2020-002674-26-GB (EUCTR) | 02/12/2020 | 26/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 11 | EUCTR2020-002674-26-AT (EUCTR) | 23/11/2020 | 18/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada | ||
| 12 | EUCTR2020-002674-26-SE (EUCTR) | 19/11/2020 | 13/11/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 13 | EUCTR2020-002674-26-NL (EUCTR) | 29/10/2020 | 15/09/2020 | A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease. | A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. | Crohns Disease MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Trade Name: Stelara 130 mg concentrate for solution for infusion Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB Trade Name: Stelara 90 mg solution for injection in pre-filled syringe Product Name: Ustekinumab Product Code: Ustekinumab INN or Proposed INN: USTEKINUMAB Other descriptive name: USTEKINUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 508 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 14 | 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 |
| 15 | EUCTR2020-001811-26-NL (EUCTR) | 30/09/2020 | 08/07/2020 | IBD under control with less medication | De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study | Crohn's disease, ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Zessly INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Amgevita INN or Proposed INN: ADALIMUMAB Trade Name: Hulio INN or Proposed INN: ADALIMUMAB | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Netherlands | ||
| 16 | EUCTR2019-003816-29-FR (EUCTR) | 16/12/2019 | 14/10/2019 | Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal | Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal - MIRACLE | Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Fecal microbiota Product Name: Fecal microbiota | ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 17 | NCT03847467 (ClinicalTrials.gov) | September 20, 2019 | 12/2/2019 | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Drug: 2'-Fucosyllactose;Other: Placebo | Children's Hospital Medical Center, Cincinnati | Broad Institute;University of Cincinnati;Connecticut Children's Medical Center | Recruiting | 11 Years | 25 Years | All | 216 | Phase 1/Phase 2 | United States |
| 18 | EUCTR2018-003594-95-NL (EUCTR) | 30/04/2019 | 30/04/2019 | Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy | Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response | Inflammatory bowel disease: Crohn's disease and Ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: methotrexate injection INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE | Amsterdam UMC location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 19 | EUCTR2018-002064-15-NL (EUCTR) | 15/04/2019 | 15/04/2019 | Patient preference model: treatment of perianal fistulas in Crohn's disease | Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 4 | Netherlands | ||
| 20 | NCT03681652 (ClinicalTrials.gov) | February 11, 2019 | 20/9/2018 | Post-Operative Crohn's Disease Outcome in Children | Post-Operative Crohn's Disease Outcome in Children (The POPCORN Trial): a Prospective Comparative Non-interventional Open Study | Crohn Disease | Drug: Azathioprine;Drug: Anti-TNF Drug | Schneider Children's Medical Center, Israel | NULL | Recruiting | 6 Years | 18 Years | All | 100 | Israel | |
| 21 | EUCTR2017-001737-85-NL (EUCTR) | 17/07/2018 | 03/04/2018 | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy | Efficacy of AlbenDazole to inDuce mUcosal healing in Patients with Crohn's disease on anti-TNF monotherapy - ADD UP | Crohn's disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: albendazole (Eskazole) Product Name: albendazole | academic medical centre | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 4 | Netherlands | ||
| 22 | NCT02872506 (ClinicalTrials.gov) | September 2017 | 16/8/2016 | Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection | Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection | Quality of Life | Drug: Anti TNF;Procedure: ileocecal resection | University Hospital, Lille | NULL | Withdrawn | 18 Years | N/A | All | 0 | N/A | NULL |
| 23 | NCT03169894 (ClinicalTrials.gov) | July 14, 2017 | 24/5/2017 | Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease | Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFa Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFa-Resistant Crohn's Disease [TRaCk LIGHT]) | Crohn Disease | Drug: MDGN-002 | Aevi Genomic Medicine, LLC, a Cerecor company | NULL | Recruiting | 18 Years | 75 Years | All | 8 | Phase 1 | United States |
| 24 | NCT02994836 (ClinicalTrials.gov) | April 21, 2017 | 24/10/2016 | GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) | Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation | Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Anti-TNF: Infliximab (Infusion);Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Active, not recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain |
| 25 | 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 | |
| 26 | NCT02772965 (ClinicalTrials.gov) | October 2016 | 27/4/2016 | Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy | Pediatric Crohn's Disease | Drug: Methotrexate;Other: Sugar pill (placebo) | University of North Carolina, Chapel Hill | Patient-Centered Outcomes Research Institute;ImproveCareNow (ICN);The Leona M. and Harry B. Helmsley Charitable Trust;Children's Hospital Medical Center, Cincinnati;Grifols Diagnostics Solutions, Inc;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Active, not recruiting | N/A | 20 Years | All | 306 | Phase 3 | United States |
| 27 | 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 |
| 28 | 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 |
| 29 | NCT02538341 (ClinicalTrials.gov) | May 2016 | 18/8/2015 | Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) | Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial) | Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Active, not recruiting | 50 Years | N/A | All | 617 | Phase 2 | United States |
| 30 | EUCTR2014-003240-12-NL (EUCTR) | 27/11/2015 | 21/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 31 | EUCTR2014-003240-12-NO (EUCTR) | 19/10/2015 | 08/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 32 | EUCTR2014-002311-41-SE (EUCTR) | 21/08/2015 | 01/07/2015 | A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy | Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Imurel 25 mg Product Name: Imurel INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE Trade Name: Puri-Nethol 50 mg Product Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Metoject Product Name: Metotrexat INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 4 | France;Netherlands;Germany;United Kingdom;Sweden | ||
| 33 | EUCTR2014-003240-12-PL (EUCTR) | 21/08/2015 | 09/06/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators orAnti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000016693;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 34 | EUCTR2014-003240-12-IT (EUCTR) | 16/07/2015 | 28/02/2018 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. - n/a | Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg Other descriptive name: A-1293543.74 | ABBVIE DEUTSCHLAND GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 35 | EUCTR2014-003240-12-ES (EUCTR) | 24/06/2015 | 27/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Anti-TNF Therapy. | Crohn's Disease MedDRA version: 17.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 36 | EUCTR2014-003240-12-SK (EUCTR) | 22/06/2015 | 09/04/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 18.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 37 | EUCTR2014-003240-12-DE (EUCTR) | 22/06/2015 | 25/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 38 | EUCTR2014-003240-12-BE (EUCTR) | 19/06/2015 | 18/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 39 | EUCTR2014-003240-12-DK (EUCTR) | 10/06/2015 | 31/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Denmark;Australia;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 40 | EUCTR2014-003240-12-HU (EUCTR) | 11/05/2015 | 25/03/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | Crohn's Disease MedDRA version: 19.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 41 | EUCTR2014-003240-12-CZ (EUCTR) | 04/05/2015 | 07/05/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT- 494 for the Induction of Symptomatic and Endoscopic Remission in Subjects with Moderately to Severely Active Crohn's Disease who have Inadequately Responded to or are Intolerant to Immunomodulators or Anti-TNF Therapy | Crohn's Disease MedDRA version: 19.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT 494 3mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 Product Name: ABT 494 12mg INN or Proposed INN: Not applicable Other descriptive name: A-1293543.74 | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Romania;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 42 | NCT02365649 (ClinicalTrials.gov) | March 17, 2015 | 16/2/2015 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy | Crohn's Disease | Drug: Placebo;Drug: ABT-494 | AbbVie | NULL | Completed | 18 Years | 75 Years | All | 220 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;United Kingdom;United States |
| 43 | EUCTR2013-002902-29-NL (EUCTR) | 12/02/2015 | 25/02/2014 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655066 10 mg/ml Product Code: BI 655066 10 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 Product Name: BI 655066 90 mg/ml Product Code: BI 655066 90 mg/ml INN or Proposed INN: not available yet Other descriptive name: BI 655066 | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Germany;Netherlands;United Kingdom;Korea, Republic of | ||
| 44 | EUCTR2013-002902-29-DE (EUCTR) | 22/12/2014 | 08/08/2014 | Efficacy, safety and pharmacokinetics of BI 655066/ABBV-066 (risankizumab) in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066/ABBV-066 (risankizumab), an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: Risankizumab 10 mg/ml INN or Proposed INN: Risankizumab Product Code: Risankizumab 90 mg/ml INN or Proposed INN: Risankizumab | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 45 | EUCTR2013-002902-29-IE (EUCTR) | 03/02/2014 | 28/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 46 | NCT02031276 (ClinicalTrials.gov) | February 2014 | 16/12/2013 | Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease. | A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naïve to, or Were Previously Treated With Anti-TNF Therapy | Crohn Disease | Drug: risankizumab IV;Drug: risankizumab SC;Drug: Placebo | AbbVie | Boehringer Ingelheim | Completed | 18 Years | 75 Years | All | 121 | Phase 2 | Belgium;Canada;France;Germany;Ireland;Korea, Republic of;Netherlands;Poland;Spain;United Kingdom;United States |
| 47 | EUCTR2013-002902-29-BE (EUCTR) | 09/01/2014 | 20/09/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Canada;Poland;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | ||
| 48 | EUCTR2013-002902-29-ES (EUCTR) | 09/01/2014 | 05/12/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml INN or Proposed INN: - Other descriptive name: BI 655066 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Netherlands;United Kingdom;Korea, Republic of | ||
| 49 | EUCTR2013-002902-29-GB (EUCTR) | 10/12/2013 | 26/11/2013 | Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease. | A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy. | Crohn's disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: BI 655066 10 mg/ml Other descriptive name: BI 655066 Product Code: BI 655066 90 mg/ml Other descriptive name: BI 655066 | Boehringer Ingelheim Limited | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Korea, Republic of | |||
| 50 | EUCTR2010-023034-23-SE (EUCTR) | 29/11/2013 | 01/11/2013 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 51 | EUCTR2010-023034-23-AT (EUCTR) | 10/10/2013 | 20/08/2013 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 52 | NCT02538757 (ClinicalTrials.gov) | October 2013 | 18/8/2015 | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE) | Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE) | Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis | Biological: Herpes Zoster Vaccine;Drug: Placebo | University of Alabama at Birmingham | Oregon Health and Science University | Active, not recruiting | 50 Years | N/A | All | 125 | Phase 2 | United States |
| 53 | JPRN-JapicCTI-142426 | 01/9/2013 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | Crohn's Disease | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : adalimumab 80mg every other week Control intervention name : null | AbbVie GK | NULL | 15 | BOTH | 28 | Phase 3 | NULL | |||
| 54 | NCT01958827 (ClinicalTrials.gov) | September 2013 | 4/10/2013 | A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease | Crohn's Disease | Biological: Adalimumab | AbbVie | NULL | Completed | 15 Years | N/A | All | 28 | Phase 3 | Japan |
| 55 | EUCTR2013-002932-25-NL (EUCTR) | 21/08/2013 | 25/07/2013 | A randomized clinical trial: treatment of perianal fistulas in Crohn's disease | Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial | Perianal fistulas in Crohn's Disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Trade Name: Humira Product Name: Adalimumab | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 56 | NCT02073526 (ClinicalTrials.gov) | May 2013 | 9/1/2014 | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Infliximab, adalimumab, certolizumab pegol | Oslo University Hospital | NULL | Completed | 18 Years | N/A | Both | 1230 | N/A | Norway |
| 57 | EUCTR2010-023034-23-CZ (EUCTR) | 12/11/2012 | 26/06/2012 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 58 | EUCTR2011-006084-22-GB (EUCTR) | 04/10/2012 | 15/08/2012 | Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment | Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease | Inflammatory bowel disease MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: Infliximab Trade Name: Humira Product Name: adalimumab INN or Proposed INN: Adalimumab | Royal Liverpool University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 0 | United Kingdom | |||
| 59 | NCT01387594 (ClinicalTrials.gov) | May 2012 | 30/6/2011 | Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs | A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA) | Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis | Procedure: lumbar puncture;Drug: lumbar puncture | Shire | NULL | Completed | 18 Years | 75 Years | All | 49 | Phase 1 | Austria;Belgium;France;Germany;Netherlands |
| 60 | EUCTR2010-023034-23-BE (EUCTR) | 12/03/2012 | 05/09/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 61 | NCT01957423 (ClinicalTrials.gov) | March 2012 | 24/9/2013 | Immune Response Regulation and Nutritional Status of the Crohn's Disease Patients. | Immune Response Regulation and Nutritional Status of Crohn's Disease Patients Under Anti-TNF-alpha and Azathioprine Therapy. | Crohn's Disease | Dietary Supplement: Whey protein;Dietary Supplement: Soy protein | University of Campinas, Brazil | Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | N/A | N/A | Both | 41 | N/A | Brazil |
| 62 | JPRN-UMIN000007343 | 2012/02/01 | 21/02/2012 | The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients | The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients - The study of the effectiveness of anti-TNF antibody maintenance treatment combined with elemental diet for Crohn's disease patients | Crohn's disease | Patients in monotherapy group receive; 1) intravenous infusion of infliximab (10mg/kg) at every 8 weeks (dose escalation of anti-TNF antibody), or 2) intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks, or subcutaneous injection of adalimumab at week 0 (160mg), 2 (80mg) and then every 2 weeks (40mg) (first time or switch of anti-TNF antibody). Patients in combination therapy group take half the amount of their daily allowance of calories (900-1,200kcal) by elemental diet and the remaining half by usual unrestricted meals, in addition to above anti-TNF antibody therapy. | Tohoku University Graduate School of Medicine (Tohoku University Hospital) | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 90 | Not applicable | Japan |
| 63 | EUCTR2010-023437-30-NO (EUCTR) | 01/12/2011 | 01/06/2011 | Study to teset whether PF-00547659 is safe and improves disease sympttoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Portugal;Serbia;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;South Africa;Norway;Germany;Netherlands;Sweden | ||
| 64 | EUCTR2010-023034-23-DE (EUCTR) | 21/11/2011 | 14/07/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 65 | EUCTR2010-023437-30-NL (EUCTR) | 11/11/2011 | 08/06/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's Disease | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Germany;Netherlands;Norway;Korea, Republic of;Sweden | |||
| 66 | EUCTR2010-023034-23-IT (EUCTR) | 21/10/2011 | 29/12/2011 | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN'S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS(ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 14.1;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-04236921 INN or Proposed INN: PF-04236921 Other descriptive name: IMP will be labeled as ''PF-04236921 106mg/vial, Clonal SC lyophilized form''. | PFIZER INC. | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Greece;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 67 | EUCTR2010-023034-23-HU (EUCTR) | 20/09/2011 | 10/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 68 | EUCTR2010-023034-23-GB (EUCTR) | 15/09/2011 | 16/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 69 | EUCTR2010-023437-30-PT (EUCTR) | 02/09/2011 | 26/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Portugal;United States;Slovakia;Slovenia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;South Africa;Bulgaria;Netherlands;Germany;Norway;Korea, Republic of;Sweden | ||
| 70 | EUCTR2010-023034-23-DK (EUCTR) | 30/08/2011 | 11/07/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Brazil;Romania;Denmark;Australia;Germany;New Zealand;Sweden | |||
| 71 | NCT02619552 (ClinicalTrials.gov) | August 2011 | 28/10/2015 | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Impact of Medical Treatment on Sexual Function in Patients With Crohn's Disease | Crohn's Disease;IBD | Drug: Anti-TNF;Drug: Steroids | University of Maryland, Baltimore | Vanderbilt University;Milton S. Hershey Medical Center;Mercy Medical Center | Completed | 18 Years | N/A | All | 50 | United States | |
| 72 | EUCTR2010-023034-23-GR (EUCTR) | 19/07/2011 | 20/06/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Ev aluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 INSUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) will be labeled as PF-04236921 106 mg/vial, Clonal SC lyophilized form, which is equivalent to PF-04236921 Powder for Injection, 106 mg/vial as described in the enclosed CTA | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | United States;Greece;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Romania;Australia;Denmark;Germany;New Zealand;Sweden | |||
| 73 | EUCTR2010-023034-23-IE (EUCTR) | 03/06/2011 | 07/04/2011 | A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE) - ANDANTE | Crohn's Disease (active moderate to severe) MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-04236921 INN or Proposed INN: Not Applicable Other descriptive name: The investigational medicinal product (IMP) may be labelled as either PF-04236921 106 mg/vial, Clonal SC lyophilized form” or PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent. | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Brazil;Belgium;Australia;Denmark;Germany;New Zealand;Sweden | ||
| 74 | EUCTR2010-023437-30-ES (EUCTR) | 03/06/2011 | 13/06/2011 | Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Estudio doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia y la seguridad de PF-00547659 en sujetos con enfermedad de Crohn que no responden adecuadamente al tratamiento anti-TNF (OPERA)A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN?S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Enfermedad de Crohn Crohn's Disease MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: PF-00547659 Product Code: PF-00547659 INN or Proposed INN: PF-00547659 Other descriptive name: No aplicable | PFIZER SLU | NULL | Not Recruiting | Female: yes Male: yes | 240 | Portugal;Slovakia;Poland;Belgium;Spain;Austria;Bulgaria;Netherlands;Norway;Germany;Sweden | |||
| 75 | EUCTR2010-023437-30-SE (EUCTR) | 01/06/2011 | 25/05/2011 | Study to test whether PF-00547659 is safe and improves disease symptoms in patients with Crohn's disease that have not responded to other treatments | A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (OPERA) - OPERA | Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Not Applicable Product Code: PF-00547659 INN or Proposed INN: Not Applicable Other descriptive name: Not applicable | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | South Africa;Germany;Netherlands;United States;Portugal;Serbia;Slovakia;Spain;Austria;France;Canada;Poland;Belgium;Croatia;Bulgaria;Norway;Sweden | ||
| 76 | NCT01287897 (ClinicalTrials.gov) | February 2011 | 31/1/2011 | A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante) | Crohn's Disease | Drug: PF-04236921 SC injection | Pfizer | NULL | Completed | 18 Years | 75 Years | All | 250 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;New Zealand;Romania;Switzerland;United Kingdom;Sweden |
| 77 | EUCTR2006-002078-23-IE (EUCTR) | 20/10/2010 | 25/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 78 | EUCTR2007-006494-90-GB (EUCTR) | 24/12/2009 | 18/06/2009 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;United Kingdom | ||
| 79 | NCT02322008 (ClinicalTrials.gov) | September 2009 | 17/12/2014 | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Biological: infliximab and adalimumab | Regionshospitalet Viborg, Skive | NULL | Completed | 18 Years | N/A | Both | 1035 | N/A | NULL |
| 80 | EUCTR2006-004784-58-GB (EUCTR) | 03/06/2009 | 30/04/2009 | An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study | An Open Label, Prospective, Multi-Center Trial on the Effect of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) on Inflammatory and Fibrous Lesions in Patients with Intestinal Crohn's Diesease. ACTIF Trial. - Effect of Infliximab on MRI lesions in Crohn's - ACTIF study | Crohn's disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Remicade Product Name: Remicade INN or Proposed INN: Infliximab | University of Leuven Hospitals | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 4 | France;Belgium;Germany;United Kingdom | ||
| 81 | EUCTR2007-006494-90-CZ (EUCTR) | 11/02/2009 | 07/11/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Czech Republic;Canada;Belgium;Poland;United Kingdom | ||
| 82 | EUCTR2006-004814-41-GB (EUCTR) | 16/01/2009 | 07/03/2008 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Trade Name: Humira 40 mg solution for injection in pre-filled pen INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | |||
| 83 | 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 | ||
| 84 | EUCTR2004-002163-24-GB (EUCTR) | 08/12/2008 | 17/02/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 85 | NCT00771667 (ClinicalTrials.gov) | December 2008 | 10/10/2008 | A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy | Crohn's Disease | Drug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP) | Centocor, Inc. | NULL | Completed | 18 Years | N/A | All | 526 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom |
| 86 | NCT00801125 (ClinicalTrials.gov) | December 2008 | 1/12/2008 | Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | A Phase IV, Open-Label Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-a Therapy | Crohn's Disease | Drug: natalizumab | Biogen | Elan Pharmaceuticals | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | NULL |
| 87 | EUCTR2007-006494-90-BE (EUCTR) | 24/11/2008 | 18/08/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbvie Deutschland GmbH & Co. K.G. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Belgium;United States;Czech Republic;Canada;Poland | ||
| 88 | 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 | ||
| 89 | 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 | ||
| 90 | 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 | ||
| 91 | EUCTR2006-004814-41-NL (EUCTR) | 24/07/2008 | 22/01/2008 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 92 | EUCTR2006-004784-58-FR (EUCTR) | 07/07/2008 | 24/06/2008 | An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease. | An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease. | Crohn's disease | Trade Name: Selective Immunosuppressive agents Product Name: Remicade 100 mg INN or Proposed INN: infliximab | CHRU de Lille | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | United Kingdom;Germany;Belgium;France | |||
| 93 | EUCTR2006-004814-41-IT (EUCTR) | 19/05/2008 | 13/03/2008 | A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND | A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND | Moderate to severe Crohn's disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA INN or Proposed INN: Adalimumab Trade Name: HUMIRA INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 94 | NCT00686374 (ClinicalTrials.gov) | May 1, 2008 | 27/5/2008 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's Disease | Biological: Adalimumab | AbbVie (prior sponsor, Abbott) | NULL | Completed | 7 Years | 18 Years | All | 100 | Phase 3 | Belgium;Canada;Czech Republic;Czechia;France;Netherlands;Poland;United Kingdom;United States |
| 95 | NCT00552344 (ClinicalTrials.gov) | May 2008 | 31/10/2007 | A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease | A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085 | Crohn Disease | Biological: Cimzia | UCB BIOSCIENCES GmbH | PPD | Completed | 18 Years | 75 Years | All | 403 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Chile;Czech Republic;Finland |
| 96 | 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 | ||
| 97 | 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 | ||
| 98 | EUCTR2006-004814-41-CZ (EUCTR) | 12/03/2008 | 01/06/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 99 | 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 | ||
| 100 | 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 | ||
| 101 | 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 | ||
| 102 | EUCTR2006-004814-41-BE (EUCTR) | 21/01/2008 | 01/06/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy | |||
| 103 | 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 | ||
| 104 | 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 | ||
| 105 | 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 | ||
| 106 | 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 | ||
| 107 | 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 | ||
| 108 | EUCTR2006-004814-41-FR (EUCTR) | 07/08/2007 | 21/05/2007 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: Humira INN or Proposed INN: Adalimumab INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 184 | Phase 3 | France;Czech Republic;Belgium;Netherlands;Italy;United Kingdom | ||
| 109 | NCT00409682 (ClinicalTrials.gov) | April 2007 | 8/12/2006 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | A Multi-Center, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Adalimumab | Abbott | NULL | Completed | 6 Years | 17 Years | All | 192 | Phase 3 | United States;Belgium;Canada;Czech Republic;France;Netherlands;Poland;United Kingdom;Italy |
| 110 | EUCTR2006-002078-23-GR (EUCTR) | 27/02/2007 | 10/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 111 | EUCTR2006-002078-23-GB (EUCTR) | 22/02/2007 | 09/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 112 | EUCTR2006-002078-23-PT (EUCTR) | 06/02/2007 | 01/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 113 | EUCTR2006-006632-22-BE (EUCTR) | 26/01/2007 | 19/12/2006 | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Change from infliximab to adalimumab in patients with Crohn’s disease in remission on infliximab: a randomized comparative case control study. - Infliximab to adalimumab switch trial | Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy MedDRA version: 8.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA Trade Name: REMICADE | University of Leuven, Division of Gastroenterology | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Belgium | ||
| 114 | EUCTR2006-002078-23-SE (EUCTR) | 10/01/2007 | 09/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira Product Code: ABT Humira Product Name: Humira pre-filled PEN Product Code: ABT Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 115 | EUCTR2006-002078-23-FI (EUCTR) | 10/01/2007 | 31/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 116 | NCT00427921 (ClinicalTrials.gov) | January 2007 | 26/1/2007 | Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) | Crohn's Disease | Biological: adalimumab | Abbott | NULL | Completed | 18 Years | N/A | All | 304 | Phase 3 | United States |
| 117 | EUCTR2006-002078-23-DE (EUCTR) | 07/12/2006 | 22/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 118 | NCT00409617 (ClinicalTrials.gov) | December 2006 | 8/12/2006 | Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | All | 945 | Phase 3 | Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Ireland;Italy;Norway;Portugal;Slovakia;Spain;Sweden;Switzerland;United Kingdom;United States |
| 119 | EUCTR2006-002078-23-DK (EUCTR) | 24/11/2006 | 26/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 120 | EUCTR2006-002078-23-FR (EUCTR) | 24/11/2006 | 29/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab Other descriptive name: ADALIMUMAB | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 121 | EUCTR2006-002078-23-ES (EUCTR) | 23/11/2006 | 19/06/2013 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.Estudio multicéntrico abierto, del anticuerpo monoclonal humano anti-TNF Adalimumab, en inducción y mantenimiento de la remisión clínica en sujetos con Enfermedad de Crohn moderada a grave. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).Enfermedad de Crohn moderada a grave. MedDRA version: 16.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 | Trade Name: Humira Product Name: Humira pre-filled PEN Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 122 | EUCTR2006-002078-23-CZ (EUCTR) | 21/11/2006 | 21/11/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Greece | |||
| 123 | EUCTR2005-005291-32-DE (EUCTR) | 24/10/2006 | 06/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 124 | EUCTR2006-002078-23-NO (EUCTR) | 23/10/2006 | 22/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. - CARE | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 125 | EUCTR2006-002078-23-BE (EUCTR) | 16/10/2006 | 16/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 126 | EUCTR2006-002078-23-NL (EUCTR) | 12/10/2006 | 10/08/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira INN or Proposed INN: adalimumab Product Name: Humira pre-filled PEN INN or Proposed INN: adalimumab | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 127 | EUCTR2006-002078-23-AT (EUCTR) | 25/09/2006 | 04/10/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease. | Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to7). MedDRA version: 8.1;Level: LLT;Classification code 10013099;Term: Disease Crohns | Trade Name: Humira Product Name: Humira pre-filled PEN | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Greece | |||
| 128 | EUCTR2005-005291-32-IT (EUCTR) | 14/09/2006 | 13/12/2006 | A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND | A multi-center, randomized, double-blind, placebo-controlled study on the Human Anti-TNF monoclonal antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn s Disease Involving the Colon - ND | Crohn s disease MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmbH Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 129 | EUCTR2005-005291-32-NL (EUCTR) | 23/08/2006 | 28/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 130 | NCT00348283 (ClinicalTrials.gov) | August 2006 | 30/6/2006 | Effects of Adalimumab on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn's Disease Involving the Colon | Crohn's Disease | Biological: adalimumab;Biological: placebo | Abbott | NULL | Completed | 18 Years | 75 Years | All | 135 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Sweden |
| 131 | EUCTR2005-005291-32-SE (EUCTR) | 25/07/2006 | 12/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 132 | EUCTR2005-005291-32-BE (EUCTR) | 20/07/2006 | 03/05/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 133 | EUCTR2005-005291-32-AT (EUCTR) | 28/06/2006 | 28/06/2006 | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | A Multi-Center, Randomized, Double-Blind, Placebo - Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon. | Crohn's Disease MedDRA version: 8.1;Level: LLT;Classification code 10057035 | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Germany;Netherlands;Belgium;Italy;Austria;Sweden | |||
| 134 | NCT00338650 (ClinicalTrials.gov) | June 2006 | 19/6/2006 | Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE) | A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab | Crohn's Disease | Drug: adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 1000 | Phase 3 | United States |
| 135 | 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 | |||
| 136 | EUCTR2004-002163-24-IT (EUCTR) | 28/02/2005 | 15/06/2005 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: HUMIRA*SC 2SIR+F 40MG 0,8ML+2T INN or Proposed INN: Adalimumab | Abbott GmBH Co KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;United Kingdom;Italy | |||
| 137 | EUCTR2004-002934-20-BE (EUCTR) | 22/02/2005 | 08/07/2005 | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 138 | EUCTR2004-002163-24-DE (EUCTR) | 09/02/2005 | 25/10/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 139 | EUCTR2004-002163-24-SE (EUCTR) | 30/12/2004 | 12/11/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 140 | EUCTR2004-002163-24-ES (EUCTR) | 17/12/2004 | 07/06/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease.Estudio multicéntrico abierto del anticuerpo monoclonal anti-TNF humano Adalimumab para evaluar la seguridad y la tolerabilidad a largo plazo de la administración repetida de Adalimumab en sujetos con enfermedad de Crohn. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 141 | EUCTR2004-002693-37-AT (EUCTR) | 10/12/2004 | 05/11/2004 | 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 - N/A | 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 - N/A | 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 | Austria;Germany | |||
| 142 | NCT00221026 (ClinicalTrials.gov) | December 2004 | 13/9/2005 | Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Crohn's Disease | A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy With UVADEX in the Treatment of Patients With Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents | Crohn's Disease | Drug: Methoxsalen +ECP;Procedure: Extracorporeal Photopheresis | Mallinckrodt | ICON plc | Completed | 18 Years | N/A | Both | 25 | Phase 2 | United States;Austria;Belgium;Germany |
| 143 | EUCTR2004-002163-24-BE (EUCTR) | 25/11/2004 | 19/08/2005 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 144 | EUCTR2004-002163-24-HU (EUCTR) | 23/11/2004 | 13/10/2004 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Trade Name: Humira Product Name: Humira INN or Proposed INN: Adalimumab | Abbott Laboratories | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 145 | EUCTR2004-002163-24-DK (EUCTR) | 16/11/2004 | 09/07/2008 | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | A Multi-Centre Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to evaluate the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease. | Crohn's Disease | Product Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 960 | Hungary;United Kingdom;Germany;Denmark;Spain;Italy | |||
| 146 | NCT00105300 (ClinicalTrials.gov) | October 2004 | 11/3/2005 | Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab | Crohn's Disease | Drug: Adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 300 | Phase 3 | United States;Belgium;Canada;France |
| 147 | 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 |
| 148 | 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 |
| 149 | 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 |
| 150 | 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 |
| 151 | NCT00077779 (ClinicalTrials.gov) | July 2003 | 12/2/2004 | Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 854 | Phase 3 | United States |
| 152 | NCT00207675 (ClinicalTrials.gov) | February 2003 | 13/9/2005 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease | A Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF a Chimeric Monoclonal Antibody (Infliximab, REMICADE) in Pediatric Subjects With Moderate to Severe CROHN'S Disease. | Crohn Disease | Drug: infliximab | Centocor, Inc. | Centocor BV | Completed | 6 Years | 17 Years | Both | 112 | Phase 3 | NULL |
| 153 | NCT01070303 (ClinicalTrials.gov) | August 2002 | 16/2/2010 | Remission in Subjects With Crohn's Disease, Open Label Extension | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension | Crohn's Disease | Biological: Adalimumab 40 mg eow or ew | Abbott | NULL | Completed | 18 Years | 75 Years | All | 177 | Phase 3 | United States |
| 154 | NCT00055497 (ClinicalTrials.gov) | August 2002 | 3/3/2003 | Remission in Subjects With Crohn's Disease, 1 Year Phase | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Biological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mg | Abbott | NULL | Completed | 18 Years | 75 Years | All | 276 | Phase 3 | United States |
| 155 | NCT00055523 (ClinicalTrials.gov) | April 2002 | 4/3/2003 | A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Drug: Adalimumab (D2E7) | Abbott | NULL | Completed | 18 Years | 75 Years | Both | 300 | Phase 2 | United States |
| 156 | NCT00207662 (ClinicalTrials.gov) | July 2000 | 13/9/2005 | A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease | ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 580 | Phase 3 | NULL |
| 157 | NCT00207766 (ClinicalTrials.gov) | June 2000 | 13/9/2005 | A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease | ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease | Crohn Disease | Drug: infliximab or placebo | Centocor, Inc. | NULL | Completed | 18 Years | N/A | Both | 306 | Phase 3 | NULL |
| 158 | NCT00269841 (ClinicalTrials.gov) | May 1996 | 22/12/2005 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease | A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease | Crohn Disease | Drug: Infliximab 10 mg/kg;Drug: Infliximab 5 mg/kg;Drug: Placebo | Centocor, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 94 | Phase 3 | NULL |
| 159 | NCT00269854 (ClinicalTrials.gov) | June 1995 | 22/12/2005 | An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease | A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease | Crohn Disease | Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Infliximab 20 mg/kg;Drug: Placebo | Centocor, Inc. | NULL | Completed | 18 Years | 65 Years | Both | 108 | Phase 2/Phase 3 | NULL |
| 160 | EUCTR2015-004121-13-Outside-EU/EEA (EUCTR) | 17/11/2015 | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics after Dose Escalation in Japanese Subjects with Crohn's Disease | Crohn's Disease MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie GK | NULL | NA | Female: yes Male: yes | 28 | Japan | ||||
| 161 | EUCTR2007-006494-90-Outside-EU/EEA (EUCTR) | 07/02/2012 | Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 | A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study | Crohn's disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 20 mg solution for injection in pre-filled syringe INN or Proposed INN: adalimumab Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use INN or Proposed INN: adalimumab | Abbott GmbH & Co. K.G. | NULL | NA | Female: yes Male: yes | 100 | Belgium;Canada;Czech Republic;Poland;United Kingdom;United States | ||||
| 162 | EUCTR2006-004814-41-Outside-EU/EEA (EUCTR) | 07/02/2012 | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | A Multicenter, Double-Blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease | Moderate to Severe Crohn's Disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 184 | NULL | ||||
| 163 | EUCTR2006-002078-23-SK (EUCTR) | 11/09/2006 | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease | A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease | Moderate to severe Crohn´s Disease (Harvey Bradshaw index score greater or equal to 7) | Trade Name: HUMIRA | Abbott GmbH & Co. KG (Abbott) | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Norway;Germany;Sweden |