Overview

Evaluation of the Efficacy 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:
Completed

Trial end date:
2019-11-05

Target enrollment:

Participant gender:

Summary

The purpose of this study was to determine how effective and safe 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 primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy

Phase:

Phase 3

Details

Lead Sponsor:

R-Pharm
R-Pharm International, LLC

Collaborators:

OCT Clinical Trials
Quintiles, Inc.

Treatments:

Adalimumab
Methotrexate