Last updated on February 2018

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ) Compared to Placebo and Adalimumab in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease


Brief description of study

The purpose of this study is to determine how safe and effective the study drug Olokizumab is, in patients with Rheumatoid Arthritis (RA) who are already receiving, but not fully responding to treatment with methotrexate (MTX).

Detailed Study Description

The goal of this Phase III study is to assess the safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who have responded inadequately to MTX. The primary endpoint of the trial is at Week 12. Olokizumab is expected to reduce the disease activity and improve physical function. The study is expected to provide safety information in a large group of subjects over at least a 24 week period. Adalimumab 40 mg q2w SC has been included as the active comparator for assay sensitivity and non inferiority evaluations.

Clinical Study Identifier: NCT02760407

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Gunther Neeck

Rheumazentrum Prof. Dr. G. Neeck
Bad Doberan, Germany
1.34miles
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