At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy
In Brief
A Phase 3 clinical trial evaluating Olokizumab 64mg q4w, Olokizumab 64mg q2w, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 1,648 participants across 203 sites in 18 countries.
Detailed Summary
The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been 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.
Study Details
Timeline
Interventions
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
0.4 or 0.8 mL prefilled, single-dose syringe
sodium chloride 0.9% solution supplied in either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule