A Study of Tocilizumab [RoActemra/Actemra] Versus Adalimumab in Patients With Rheumatoid Arthritis
Status: | Archived |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | May 2010 |
End Date: | September 2012 |
A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
This randomized, blinded, parallel arm study will evaluate the efficacy and safety of
tocilizumab [RoActemra/Actemra] versus adalimumab as monotherapy in patients with rheumatoid
arthritis who are intolerant of methotrexate or where continued treatment with methotrexate
is considered inappropriate. Patients will be randomized to receive either tocilizumab
(8mg/kg intravenously) every 4 weeks plus placebo sc every 2 weeks, or adalimumab (40mg
subcutaneously) every 2 weeks plus placebo iv every 4 weeks. Anticipated time on study
treatment is 24 weeks. With regard to the blind, the study nurse will be unblinded due to
the nature of the treatment administration, but the investigator and the patient will remain
blinded. Target sample size is 200-400 patients.
We found this trial at
21
sites
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