A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | July 2005 |
| End Date: | December 2007 |
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus
methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized
to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate
7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is
3-12 months and the target sample size is 500+ individuals.
methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized
to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate
7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is
3-12 months and the target sample size is 500+ individuals.
Inclusion Criteria:
- adult patients at least 18 years of age with active RA for at least 3 months;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria:
- major surgery (including joint surgery) within 8 weeks before entering study or
planned major surgery within 6 months after entering study;
- treatment with methotrexate (MTX) within 6 months of entering study;
- patients who have stopped previous MTX treatment due to toxicity or lack of response;
- women who are pregnant or breast-feeding.
We found this trial at
67
sites
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