97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2015-001346-29-SK (EUCTR) | 12/11/2015 | 30/10/2015 | 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: 20.1;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 Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL) 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 | 59 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Poland;Japan;New Zealand;Sweden | ||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | |||
| 6 | 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 | |||
| 7 | 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 | |||
| 8 | 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 | |||
| 9 | 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 | |||
| 10 | 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 | |||
| 11 | 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 | |||
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | |||
| 15 | 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 | |||
| 16 | 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 | |||
| 17 | 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 | Phase 3 | Denmark | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | EUCTR2007-004157-28-FR (EUCTR) | 10/07/2008 | 14/04/2008 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | EUCTR2015-001346-29-PL (EUCTR) | 21/03/2016 | 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: 20.1;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 Trade Name: Humira 20 mg solution for injection in pre-filled syringe (20 mg/0.2mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40 mg solution for injection in pre-filled syringe (40 mg/0.4 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB Trade Name: Humira 80 mg solution for injection in pre-filled syringe (80 mg/0.8 mL) Product Name: Adalimumab Product Code: 331731-18-1 INN or Proposed INN: ADALIMUMAB | AbbVie Deutschland GmbH & Co. KG | NULL | NA | Female: yes Male: yes | 59 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Czech Republic;Hungary;European Union;Canada;Poland;Belgium;Japan;New Zealand;Sweden |