Rgb-03 (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 | 2 |
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 | EUCTR2014-003255-54-CZ (EUCTR) | 21/01/2015 | 24/10/2014 | A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis | A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients | Rheumatoid arthritis MedDRA version: 18.1;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: RGB-03 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB | Gedeon Richter Plc | NULL | Not Recruiting | Female: yes Male: yes | 142 | Phase 1;Phase 3 | Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany | ||
2 | NCT02371096 (ClinicalTrials.gov) | January 2015 | 5/2/2015 | Comparative Pharmacokinetic Trial of RGB-03 and MabThera | Rheumatoid Arthritis | Drug: MabThera (rituximab);Drug: RGB-03 | Gedeon Richter Plc. | NULL | Not yet recruiting | 18 Years | 75 Years | Both | Phase 1 | NULL |