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

    Not Recruiting
  • participants needed
  • sponsor
Updated on 5 May 2021
Bernardo Antonio Pons Estel
Primary Contact
Sanatorio Parque S.A. (0.0 mi away) Contact
+224 other location
folic acid


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).


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.

Condition Rheumatoid Arthritis
Treatment Placebo q2w, Olokizumab 64mg q4w, Olokizumab 64mg q2w, Adalimumab 40mg q2w
Clinical Study IdentifierNCT02760407
Last Modified on5 May 2021

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