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

  • STATUS
    Not Recruiting
  • participants needed
    1575
  • sponsor
    R-Pharm
Updated on 5 May 2021
Investigator
Sabeen Najam
Primary Contact
Accurate Clinical Management LLC (2.5 mi away) Contact
+224 other location
methotrexate
adalimumab
folic acid
folate

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 methotrexate (MTX).

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.

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

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note