46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| 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 | EUCTR2010-023956-99-CZ (EUCTR) | 29/11/2011 | 17/06/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014) | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil | ||
| 2 | EUCTR2010-023956-99-DE (EUCTR) | 22/09/2011 | 01/06/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 3 | EUCTR2010-023956-99-HU (EUCTR) | 17/08/2011 | 18/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 4 | EUCTR2010-023956-99-NL (EUCTR) | 28/07/2011 | 30/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Protocol Amendment 03 (v1.0, dated 08-Mar-2011) | RHEUMATOID ARTHRITIS,NOS MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of | ||
| 5 | EUCTR2010-023956-99-BE (EUCTR) | 20/07/2011 | 24/05/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 | RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: CLAZAKIZUMAB Product Code: BMS-945429 INN or Proposed INN: CLAZAKIZUMAB | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 677 | Phase 2 | United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of | ||
| 6 | EUCTR2010-023956-99-ES (EUCTR) | 20/07/2011 | 03/11/2011 | Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate | A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) - | RHEUMATOID ARTHRITIS,NOS MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Anti-Interleukin-6 Monoclonal Antibody Product Code: BMS-945429 INN or Proposed INN: BMS-945429 Other descriptive name: anti-IL-6 mAb Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 677 | Phase 2 | Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States |