Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate
This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in
combination with RoActemra in patients with active rheumatoid arthritis despite a stable
dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either
MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending
doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo
arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive
MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at
weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8
and 12.
All patients will then be eligible to receive extension treatment withRoActemra every 4
weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is
<100 individuals.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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