Trials / Completed
CompletedNCT00144521
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)
A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRA(Tocilizumab) | 8mg/kg/4week(i.v.)for 24 weeks |
| DRUG | MRA placebo | 0mg/kg/4week(i.v.) for 24 weeks |
| DRUG | MTX | 8mg/week(p.o.) for 24 weeks |
| DRUG | MTX placebo | 0mg/week(p.o.) for 24 weeks |
Timeline
- Start date
- 2004-02-01
- Primary completion
- 2004-08-01
- Completion
- 2006-04-01
- First posted
- 2005-09-05
- Last updated
- 2009-02-02
Source: ClinicalTrials.gov record NCT00144521. Inclusion in this directory is not an endorsement.