97. Ulcerative colitis
2,269 clinical trials, 1,331 drugs (DrugBank: 241 drugs), 114 drug target genes, 181 drug target pathways
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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-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 | ||
| 2 | NCT04131322 (ClinicalTrials.gov) | October 2019 | 10/10/2019 | Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. | Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study | Crohn Disease;Ulcerative Colitis | Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | NULL | Not yet recruiting | 18 Years | N/A | All | 216 | Phase 4 | NULL |
| 3 | EUCTR2013-004279-11-FR (EUCTR) | 03/06/2019 | 09/04/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 4 | EUCTR2013-004277-27-HU (EUCTR) | 11/04/2019 | 25/02/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 5 | EUCTR2013-004277-27-CZ (EUCTR) | 18/03/2019 | 29/03/2019 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 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 |
| 6 | EUCTR2015-001346-29-CZ (EUCTR) | 13/11/2017 | 03/06/2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden | ||
| 7 | EUCTR2016-001409-18-NO (EUCTR) | 06/12/2016 | 09/05/2016 | A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence | A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Helse More og Romsdal Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 8 | NCT02750800 (ClinicalTrials.gov) | April 7, 2016 | 13/4/2016 | Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE) | Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis | Biological: Adalimumab;Behavioral: AbbVie Care 2.0 | AbbVie | NULL | Completed | 18 Years | 99 Years | All | 427 | Hungary | |
| 9 | EUCTR2015-001346-29-GB (EUCTR) | 08/02/2016 | 28/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden | ||
| 10 | EUCTR2015-001346-29-HU (EUCTR) | 02/02/2016 | 28/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 93 | Phase 3 | United States;Hungary;Canada;Spain;Australia;Israel;United Kingdom;New Zealand | ||
| 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 |
| 11 | EUCTR2015-000939-33-GB (EUCTR) | 06/11/2015 | 29/10/2015 | Efficacy and Safety of Vedolizumab IV in Subjects With Ulcerative Colitis compared to Adalimumab SC | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis - Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | Takeda Development Centre Europe, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 758 | Phase 3 | Serbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Denmark;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 12 | EUCTR2013-003032-77-PL (EUCTR) | 05/11/2015 | 28/08/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;New Zealand | ||
| 13 | EUCTR2013-004277-27-BG (EUCTR) | 12/01/2015 | 06/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 14 | EUCTR2013-004279-11-BG (EUCTR) | 12/01/2015 | 06/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 15 | EUCTR2013-001682-16-PL (EUCTR) | 08/12/2014 | 22/09/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 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 |
| 16 | EUCTR2013-004277-27-GR (EUCTR) | 08/12/2014 | 08/12/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 17 | EUCTR2013-001682-16-NL (EUCTR) | 28/11/2014 | 01/05/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Japan | ||
| 18 | EUCTR2013-004279-11-SK (EUCTR) | 13/11/2014 | 08/10/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 19 | EUCTR2013-003032-77-CZ (EUCTR) | 06/11/2014 | 31/07/2014 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in PediatricSubjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;New Zealand | ||
| 20 | EUCTR2013-003032-77-GB (EUCTR) | 30/10/2014 | 19/12/2013 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 85 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand | ||
| 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 |
| 21 | EUCTR2013-004279-11-EE (EUCTR) | 03/10/2014 | 09/09/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I | Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria | ||
| 22 | EUCTR2013-004277-27-LT (EUCTR) | 30/09/2014 | 22/07/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 23 | EUCTR2013-001682-16-DE (EUCTR) | 22/09/2014 | 10/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 24 | EUCTR2013-003032-77-IT (EUCTR) | 10/09/2014 | 19/12/2013 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand | ||
| 25 | EUCTR2013-001682-16-IT (EUCTR) | 02/09/2014 | 23/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 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 |
| 26 | EUCTR2013-001682-16-CZ (EUCTR) | 21/08/2014 | 18/06/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 27 | EUCTR2013-004277-27-HR (EUCTR) | 12/08/2014 | 05/09/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 28 | EUCTR2013-004277-27-LV (EUCTR) | 28/07/2014 | 21/07/2014 | A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II | Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand | ||
| 29 | EUCTR2013-001682-16-AT (EUCTR) | 03/07/2014 | 16/06/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection Product Name: ADALIMUMAB Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan | ||
| 30 | EUCTR2013-005013-13-PL (EUCTR) | 25/06/2014 | 31/03/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of | |||
| 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 |
| 31 | EUCTR2013-001682-16-HU (EUCTR) | 18/06/2014 | 22/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | United States;Hungary;Slovakia;Canada;Israel;Japan;Switzerland | |||
| 32 | EUCTR2013-001682-16-SK (EUCTR) | 10/06/2014 | 29/04/2014 | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Germany;Netherlands;Japan | ||
| 33 | EUCTR2013-005013-13-BG (EUCTR) | 28/04/2014 | 23/04/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||
| 34 | EUCTR2013-005013-13-LT (EUCTR) | 08/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 35 | EUCTR2013-005013-13-CZ (EUCTR) | 03/04/2014 | 13/02/2014 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 INN or Proposed INN: ADALIMUMAB Other descriptive name: SB5 Trade Name: Humira® Product Name: Humira® INN or Proposed INN: ADALIMUMAB | Samsung Bioepis Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | |||
| 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 |
| 36 | EUCTR2011-002411-29-PL (EUCTR) | 19/12/2013 | 17/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 37 | EUCTR2011-002411-29-CZ (EUCTR) | 15/11/2013 | 16/09/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 38 | EUCTR2011-002411-29-SK (EUCTR) | 11/11/2013 | 14/10/2013 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 39 | 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 | |||
| 40 | EUCTR2011-002411-29-ES (EUCTR) | 10/08/2012 | 18/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 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 |
| 41 | NCT01670240 (ClinicalTrials.gov) | August 2012 | 8/8/2012 | Adalimumab in the Treatment of Chronic Pouchitis | Adalimumab (Humira) in the Treatment of Chronic Pouchitis | Ulcerative Colitis;Pouchitis | Drug: Adalimumab;Drug: Placebo | Odense University Hospital | University of Southern Denmark;Hvidovre University Hospital;Aarhus University Hospital;AbbVie | Completed | 18 Years | N/A | Both | 13 | Phase 3 | Denmark |
| 42 | EUCTR2011-002411-29-FI (EUCTR) | 29/06/2012 | 11/06/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 15.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 43 | EUCTR2011-002411-29-AT (EUCTR) | 26/06/2012 | 01/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 44 | EUCTR2011-002411-29-PT (EUCTR) | 01/06/2012 | 03/01/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 45 | EUCTR2011-002411-29-DE (EUCTR) | 11/05/2012 | 11/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 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 |
| 46 | EUCTR2011-002411-29-GB (EUCTR) | 03/05/2012 | 07/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbvie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 47 | EUCTR2011-002411-29-SE (EUCTR) | 26/04/2012 | 13/10/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 48 | EUCTR2011-002411-29-IE (EUCTR) | 30/03/2012 | 09/02/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 17.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | |||
| 49 | EUCTR2011-002411-29-DK (EUCTR) | 30/03/2012 | 28/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 16.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 50 | EUCTR2011-002411-29-BE (EUCTR) | 07/03/2012 | 23/11/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 455 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Norway;Sweden | |||
| 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 |
| 51 | EUCTR2011-002411-29-IT (EUCTR) | 20/02/2012 | 07/03/2012 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. | Ulcerative Colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;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 | ABBOTT GMBH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Canada;Poland;Belgium;Denmark;Germany;Sweden | |||
| 52 | EUCTR2011-002411-29-GR (EUCTR) | 09/01/2012 | 07/12/2011 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: ADALIMUMAB | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 680 | Portugal;Slovakia;Greece;Finland;Spain;Ireland;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 53 | EUCTR2011-004268-31-DK (EUCTR) | 13/12/2011 | 21/11/2011 | Adalimumab (Humira) in the treatment of chronic pouchitis | Adalimumab (Humira) in the treatment of chronic pouchitis | Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0;Level: PT;Classification code 10036463;Term: Pouchitis;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 syringes Product Name: Humira Product Code: EMEA/H/C/000481 | Odense University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 24 | Denmark | |||
| 54 | EUCTR2007-004157-28-SE (EUCTR) | 22/10/2009 | 06/05/2009 | Long-term open-label safety and efficacy study of Adalimumab in subjectswith Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 55 | EUCTR2007-004157-28-PT (EUCTR) | 17/03/2009 | 12/12/2008 | A Multicenter, 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 Ulcerative Colitis | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 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 |
| 56 | EUCTR2007-004157-28-NL (EUCTR) | 09/12/2008 | 10/12/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 57 | EUCTR2007-004157-28-DE (EUCTR) | 07/08/2008 | 25/03/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 58 | EUCTR2007-004157-28-SK (EUCTR) | 04/08/2008 | 09/04/2008 | A Multicenter, 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 Ulcerative Colitis | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 59 | EUCTR2007-004157-28-HU (EUCTR) | 09/07/2008 | 28/03/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden;Portugal;Slovakia | ||
| 60 | EUCTR2007-004157-28-BE (EUCTR) | 23/06/2008 | 13/12/2007 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Germany;Norway;New Zealand;Sweden;Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Denmark;Australia;Netherlands | ||
| 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 |
| 61 | EUCTR2007-004157-28-CZ (EUCTR) | 09/06/2008 | 10/04/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 62 | EUCTR2006-002781-20-SE (EUCTR) | 23/05/2008 | 04/03/2008 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 63 | EUCTR2007-004157-28-AT (EUCTR) | 30/04/2008 | 08/04/2008 | Long-term open-label safety and efficacy study of Adalimumab in subjects with Ulcerative Colitis. | A Multicenter, 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 Ulcerative Colitis | Ulcerative Colitis MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira | AbbVie Deutschland GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 592 | Phase 3 | Portugal;Slovakia;Spain;Austria;Israel;Italy;Switzerland;France;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 64 | EUCTR2006-002782-40-AT (EUCTR) | 16/03/2008 | 20/03/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 65 | EUCTR2006-002781-20-AT (EUCTR) | 27/02/2008 | 23/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 475 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 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 |
| 66 | EUCTR2006-002782-40-DE (EUCTR) | 20/02/2008 | 18/04/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria | |||
| 67 | EUCTR2006-002782-40-PT (EUCTR) | 07/09/2007 | 18/06/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria | |||
| 68 | EUCTR2006-002781-20-BE (EUCTR) | 16/07/2007 | 10/01/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 475 | Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden | |||
| 69 | EUCTR2006-002782-40-DK (EUCTR) | 09/07/2007 | 07/03/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 70 | EUCTR2006-002781-20-DE (EUCTR) | 27/06/2007 | 04/04/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Czech Republic;Germany;Italy;Austria;Sweden | |||
| 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 |
| 71 | EUCTR2006-002782-40-BE (EUCTR) | 19/06/2007 | 05/01/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany | |||
| 72 | EUCTR2006-002782-40-FR (EUCTR) | 19/06/2007 | 06/03/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 73 | EUCTR2006-002782-40-CZ (EUCTR) | 18/06/2007 | 10/04/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria | |||
| 74 | EUCTR2006-002781-20-CZ (EUCTR) | 04/05/2007 | 16/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 75 | EUCTR2006-002782-40-HU (EUCTR) | 18/04/2007 | 20/03/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany | |||
| 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 |
| 76 | EUCTR2006-002781-20-IT (EUCTR) | 17/04/2007 | 07/03/2007 | A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND | A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND | Moderately to severely active Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Trade Name: HUMIRA | Abbott GmbH Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 77 | EUCTR2006-002781-20-HU (EUCTR) | 26/03/2007 | 28/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Hungary;Germany;Czech Republic;Italy;Austria;Sweden | |||
| 78 | EUCTR2006-002782-40-ES (EUCTR) | 23/03/2007 | 05/02/2007 | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa. | A Multicenter, 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 Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa. | Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany | |||
| 79 | EUCTR2006-002781-20-SK (EUCTR) | 19/03/2007 | 01/02/2007 | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis. | Moderately to severely active ulcerative colitis. MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Humira INN or Proposed INN: Adalimumab | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 575 | Phase 3 | Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden | ||
| 80 | EUCTR2014-004559-29-Outside-EU/EEA (EUCTR) | 12/11/2014 | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;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 Inc. | NULL | NA | Female: yes Male: yes | 274 | Japan | ||||
| 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 |
| 81 | EUCTR2015-001346-29-SE (EUCTR) | 30/09/2015 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;United Kingdom;New Zealand;Japan;Sweden | |||
| 82 | EUCTR2015-001346-29-AT (EUCTR) | 12/01/2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 93 | Phase 3 | United States;Spain;Austria;Israel;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Japan;New Zealand;Sweden |