drugset / Trial / NCT00535782
A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.
Timeline
- Start
- 2007-10-31
- Primary completion
- 2008-09-30
- Completion
- 2011-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Background | Methotrexate | Small molecule | 7.5 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |