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 | EUCTR2010-018485-24-HU (EUCTR) | 29/06/2012 | 02/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. 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] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Czech Republic;Hungary;Spain;Latvia;Germany | |||
| 2 | EUCTR2010-018485-24-LV (EUCTR) | 15/06/2012 | 14/05/2012 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. 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] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Hungary;Germany;Czech Republic;Spain;Latvia | |||
| 3 | EUCTR2010-018485-24-DE (EUCTR) | 18/05/2011 | 28/01/2011 | To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. 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] - Immune System Diseases [C20] | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 176 | Hungary;Czech Republic;Spain;Latvia;Germany | |||
| 4 | EUCTR2010-018485-24-ES (EUCTR) | 12/04/2011 | 04/11/2010 | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Hungary;Germany;Czech Republic;Spain;Latvia | |||
| 5 | EUCTR2010-018485-24-CZ (EUCTR) | 20/10/2010 | 24/08/2010 | To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis | A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA | Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses. 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: BT061 Product Code: BT061 INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 128 | Hungary;Czech Republic;Spain;Latvia;Germany |