MedTrace Logo

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

NCT03120949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2106

Last updated 2023-10-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Olokizumab 64 mg SC q4w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

DRUG

Olokizumab 64 mg SC q2w

160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL.

DRUG

Concomitant treatment

Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.) Folic acid ≥ 5 mg per week or equivalent

Sponsors & Collaborators

  • IQVIA Pvt. Ltd

    collaborator INDUSTRY

  • OCT Clinical Trials

    collaborator OTHER

  • R-Pharm International, LLC

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-04
Primary Completion
2021-09-01
Completion
2021-09-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belarus
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03120949 on ClinicalTrials.gov