Abt-humira (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 2 |
| 97 | 潰瘍性大腸炎 | 9 |
| 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 | EUCTR2007-005905-23-DE (EUCTR) | 13/05/2008 | 29/01/2008 | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira 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 | 424 | United Kingdom;Germany | |||
| 2 | EUCTR2007-005905-23-GB (EUCTR) | 22/04/2008 | 15/02/2008 | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07 | A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing - M10-261, FINAL 30Nov07 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira 40 mg solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab Other descriptive name: ABT-Humira 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 | 424 | Germany;United Kingdom |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 |