At a glance
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A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate
In Brief
A Phase 2 clinical trial evaluating Placebo matched to atacicept, Atacicept: with loading dose, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 311 participants across 2 sites in 2 countries.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of atacicept compared to placebo in the treatment of signs and symptoms in a subject population with active rheumatoid arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.
Study Details
Timeline
Interventions
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.
Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.