Evaluation of the Long Term Safety Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ) in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1 2 or 3.

  • STATUS
    Recruiting
  • End date
    Nov 22, 2021
  • participants needed
    1880
  • sponsor
    R-Pharm
Updated on 22 January 2021
methotrexate
folic acid
folate

Summary

The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.

Description

The goal of this Phase III study is to evaluate the long-term safety, tolerability, and efficacy of OKZ in subjects with moderately to severely active RA who previously completed 24 weeks of double-blind treatment with OKZ in the core studies. OKZ is expected to reduce the disease activity and induce an improvement in physical function. The study is expected to provide long-term safety information in a large group of subjects treated with OKZ for up to 106 weeks.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment methotrexate, Olokizumab 64 mg SC q4w, Olokizumab 64 mg SC q2w
Clinical Study IdentifierNCT03120949
SponsorR-Pharm
Last Modified on22 January 2021

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