Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ) Compared to Placebo in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease

  • STATUS
    Not Recruiting
  • participants needed
    350
  • sponsor
    R-Pharm
Updated on 25 January 2021
Investigator
Javier Dario Marquez Hernandez
Primary Contact
Hospital Pablo Tob n Uribe (5.1 mi away) Contact
+137 other location
folic acid
folate
tumour necrosis

Summary

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 an existing medication called a tumour necrosis factor alpha inhibitor

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 TNFi therapy. 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.

Details
Condition Rheumatoid Arthritis
Treatment Olokizumab q4w, Olokizumab q2w, Placebo q2w
Clinical Study IdentifierNCT02760433
SponsorR-Pharm
Last Modified on25 January 2021

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