Mabioncd20 (DrugBank: -)
1 disease| 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 | 3 |
| 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 | EUCTR2012-003194-25-HR (EUCTR) | 17/03/2014 | 03/09/2014 | Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Mabion S.A. | NULL | Not Recruiting | Female: yes Male: yes | 863 | Phase 3 | Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia | |||
| 2 | NCT02468791 (ClinicalTrials.gov) | May 2013 | 9/6/2015 | MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab | Mabion SA | NULL | Completed | 18 Years | 80 Years | All | 709 | Phase 3 | Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine |
| 3 | EUCTR2012-003194-25-LT (EUCTR) | 04/02/2013 | 24/09/2012 | Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis | Active Rheumatoid Arthritis MedDRA version: 17.0;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: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB | Mabion S.A. | NULL | Not Recruiting | Female: yes Male: yes | 863 | Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia |