Adalimumab 40 mg (DrugBank: Adalimumab)
16 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 19 | ライソゾーム病 | 0 |
| 37 | 膿疱性乾癬（汎発型） | 0 |
| 40 | 高安動脈炎 | 0 |
| 41 | 巨細胞性動脈炎 | 0 |
| 46 | 悪性関節リウマチ | 15 |
| 56 | ベーチェット病 | 0 |
| 84 | サルコイドーシス | 0 |
| 96 | クローン病 | 5 |
| 97 | 潰瘍性大腸炎 | 0 |
| 151 | ラスムッセン脳炎 | 0 |
| 160 | 先天性魚鱗癬 | 0 |
| 164 | 眼皮膚白皮症 | 0 |
| 222 | 一次性ネフローゼ症候群 | 0 |
| 226 | 間質性膀胱炎（ハンナ型） | 0 |
| 269 | 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群 | 0 |
| 271 | 強直性脊椎炎 | 1 |
| 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 | NCT02019472 (ClinicalTrials.gov) | April 4, 2014 | 18/12/2013 | A Study Comparing Sirukumab (CNTO 136) Monotherapy With Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis | A Multicenter, Randomized, Double-blind, Parallel Group Study of Sirukumab Monotherapy Compared With HUMIRA® Monotherapy Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: adalimumab 40 mg;Biological: sirukumab 100 mg;Biological: sirukumab 50 mg;Drug: Placebo | Janssen Research & Development, LLC | GlaxoSmithKline | Completed | 18 Years | N/A | All | 559 | Phase 3 | United States;Bulgaria;Chile;Colombia;Germany;Hungary;Lithuania;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Ukraine;Argentina;Peru |
| 2 | EUCTR2009-015845-21-GR (EUCTR) | 04/10/2010 | 04/10/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden | |||
| 3 | EUCTR2009-015845-21-PT (EUCTR) | 01/10/2010 | 22/07/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden | |||
| 4 | EUCTR2009-015845-21-DE (EUCTR) | 22/07/2010 | 18/03/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden | |||
| 5 | EUCTR2009-015845-21-CZ (EUCTR) | 16/07/2010 | 26/03/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;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 | EUCTR2009-015845-21-SE (EUCTR) | 06/07/2010 | 10/05/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden | |||
| 7 | EUCTR2009-015845-21-FI (EUCTR) | 16/06/2010 | 30/04/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden | |||
| 8 | EUCTR2009-015845-21-BE (EUCTR) | 08/06/2010 | 04/05/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden | ||
| 9 | EUCTR2009-015845-21-GB (EUCTR) | 13/05/2010 | 17/03/2010 | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis | Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden | |||
| 10 | EUCTR2009-015845-21-ES (EUCTR) | 12/05/2010 | 12/01/2012 | A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity. | A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis. | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB | F. Hoffmann-La Roche Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Portugal;Germany;Switzerland;Turkey;Sweden;Australia;Brazil;Finland;United Kingdom;Czech Republic;Mexico;Belgium;Spain;Greece;United States | |||
| 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 | NCT01119859 (ClinicalTrials.gov) | May 2010 | 1/4/2010 | A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis | A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 326 | Phase 4 | United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway |
| 12 | JPRN-JapicCTI-080587 | 01/6/2008 | Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis | A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis | Juvenile Rheumatoid Arthritis (JRA) | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : adalimumab 20 mg for chldren with body weight < 30 kg; adalimumab 40 mg for chldren with body weight >= 30 kg Control intervention name : null | Abbott Japan Co., Ltd. | Eisai Co., Ltd. | 4 | 17 | BOTH | 25 | Phase 3 | NULL | ||
| 13 | NCT00538902 (ClinicalTrials.gov) | August 2007 | 1/10/2007 | Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate | A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate | Rheumatoid Arthritis | Biological: Placebo;Biological: Adalimumab 80 mg;Biological: Adalimumab 40 mg | Abbott | NULL | Completed | 18 Years | N/A | All | 302 | Phase 2;Phase 3 | China |
| 14 | NCT00216177 (ClinicalTrials.gov) | September 2005 | 20/9/2005 | Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis | Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks | Rheumatoid Arthritis | Drug: Infliximab;Drug: Adalimumab | Hvidovre University Hospital | University Hospital, Gentofte, Copenhagen | Recruiting | 18 Years | 80 Years | Both | 112 | Phase 4 | Denmark |
| 15 | NCT00233571 (ClinicalTrials.gov) | June 2000 | 13/9/2005 | A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis | A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab) | Rheumatoid Arthritis | Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW) | Abbott | NULL | Completed | 18 Years | N/A | Both | 796 | Phase 3 | NULL |
| 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 | JPRN-UMIN000024566 | 2016/11/01 | 01/11/2016 | Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy. | Crohn'disease | Dose escalation group Administration of Adalimumab 80 mg every other week Non-dose escalation group Administration of Adalimumab 40 mg every other week | Toho University Medical Center Sakura Hospital | NULL | Pending | 16years-old | Not applicable | Male and Female | 60 | Not applicable | Japan | |
| 2 | JPRN-UMIN000023871 | 2016/08/25 | 01/09/2016 | Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) | Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) - Comparison of efficacy between adalimumab 80mg every other week vs 40mg every week in Crohn's disease(WAVE-K study) | Crohn's disease | Administration of Adalimumab 80 mg every 2 weeks. Administration of Adalimumab 40 mg every week. | Fukuoka University Chikushi Hospital | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 100 | Not applicable | Japan |
| 3 | JPRN-UMIN000009596 | 2013/01/01 | 21/12/2012 | Withdrawal of immunomodulator in Crohn's disease treated with adalimumab and immnomodulator : a multicenter randomized trial(Diamond2 study). | Crohn`s disease | Withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. Non-withdrawal of the concomitant immunomodulator (azathioprine or 6-mercaptoprine) while under adalimumab 40 mg/every other week continued treatment. | Department of Internal Medicine, School of Medicine, Keio University | NULL | Complete: follow-up complete | 15years-old | Not applicable | Male and Female | 200 | Not selected | Japan | |
| 4 | NCT01070303 (ClinicalTrials.gov) | August 2002 | 16/2/2010 | Remission in Subjects With Crohn's Disease, Open Label Extension | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension | Crohn's Disease | Biological: Adalimumab 40 mg eow or ew | Abbott | NULL | Completed | 18 Years | 75 Years | All | 177 | Phase 3 | United States |
| 5 | NCT00055497 (ClinicalTrials.gov) | August 2002 | 3/3/2003 | Remission in Subjects With Crohn's Disease, 1 Year Phase | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease | Crohn's Disease | Biological: Double-blind (DB) adalimumab placebo;Biological: DB adalimumab 40 mg eow;Biological: DB adalimumab 40 mg ew;Biological: OL adalimumab 40 mg | Abbott | NULL | Completed | 18 Years | 75 Years | All | 276 | Phase 3 | United States |
| 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 | NCT00235105 (ClinicalTrials.gov) | March 2005 | 6/10/2005 | D2E7-Early AS | Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase | Ankylosing Spondylitis | Drug: Adalimumab 40 mg sc every other week | Charite University, Berlin, Germany | Abbott | Active, not recruiting | 18 Years | N/A | Both | 46 | Phase 2;Phase 3 | Germany |