A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs
Summary
This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.
Timeline
- Start
- 2010-03
- Primary completion
- 2011-09
- Completion
- 2011-09
Outcome
Mixed primary results
registry MEDIAN Tocilizumab 8 mg/kg: 2nd to 5th MCP joints (n=25,14): -25.0 (-91.7 to 100.0) percent change NCT01034397 ↗
registry analysis (superiority or other test); Tocilizumab 8 mg/kg vs Placebo; p = 0.026; t-test, 1 sided; note: 2nd and 5th MCP joints: Tocilizumab versus placebo NCT01034397 ↗
registry MEDIAN Tocilizumab 8 mg/kg: Wrist region (n=30,17): -20.0 (-100.0 to 200.0) percent change NCT01034397 ↗
registry analysis (superiority or other test); Tocilizumab 8 mg/kg vs Placebo; p = 1.00; t-test, 1 sided; note: Wrist region: Tocilizumab versus placebo NCT01034397 ↗
registry MEDIAN Tocilizumab 8 mg/kg: Total synovitis score (n=30,17): -23.6 (-80.0 to 1200.0) percent change NCT01034397 ↗
registry analysis (superiority or other test); Tocilizumab 8 mg/kg vs Placebo; p = 1.00; t-test, 1 sided; note: Total synovitis score: Tocilizumab versus placebo NCT01034397 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |