OncRef

Clinical Trial: NCT03120949

Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:R-Pharm International, LLC
Information Provided By:R-Pharm
Last Update Posted:2023-10-12

Study Overview

Brief Summary

The primary objective of this study was to evaluate the long-term safety and tolerability of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) in subjects with moderately to severely active rheumatoid arthritis (RA) who previously had completed 24 weeks of double-blind treatment in Study CREDO 1, 2 or 3 (core studies). The long-term efficacy, immunogenicity, the physical function and quality of life of subjects received long-term treatment with OKZ were assessed as well.

Official Title

A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

Intervention / Treatment

  • Drug: Olokizumab 64 mg SC q4w
  • Drug: Olokizumab 64 mg SC q2w
  • Drug: Concomitant treatment

Other Study ID Numbers

  • CL04041024
  • 2015-005309-35
  • 2015

Start Date (Actual)

2017-07-04

Primary Completion Date (Actual)

2021-09-01

Study Completion Date (Actual)

2021-09-01

Enrollment (Actual)

2106

Study Type

Interventional

Phase

Phase 3