46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | EUCTR2011-004171-36-ES (EUCTR) | 30/03/2012 | 30/01/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe 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] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of | |||
| 2 | EUCTR2011-004171-36-PL (EUCTR) | 29/03/2012 | 22/02/2012 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe 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] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 3 | EUCTR2011-004171-36-GB (EUCTR) | 24/02/2012 | 15/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe 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] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 4 | EUCTR2011-004171-36-HU (EUCTR) | 23/02/2012 | 16/12/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe 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] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland | |||
| 5 | EUCTR2011-004171-36-CZ (EUCTR) | 15/02/2012 | 30/11/2011 | A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA) | Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera® Product Name: MabThera® INN or Proposed INN: RITUXIMAB | Samsung Electronics Co. Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 616 | Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland |