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Monoclonal Antibodies

Treatment Arm 1: OKZ 64 mg q4w + MTX for Rheumatoid Arthritis (CREDO 4 Trial)

Phase 3
Waitlist Available
Research Sponsored by R-Pharm
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 126
Awards & highlights

Summary

This trial looked at the long-term safety and tolerability of olokizumab (OKZ) in people with RA who had completed 24 weeks of treatment in a previous study. The trial also looked at the long-term efficacy, immunogenicity, physical function and quality of life of people who received long-term treatment with OKZ.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 126
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 126 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence Rate of Treatment Emergent AESIs (Safety Population)
Incidence Rate of Treatment Emergent AEs Per Patient-years of Exposure
Incidence Rate of Treatment Emergent SAEs Per Patient-years of Exposure
+2 more
Secondary outcome measures
American College of Rheumatology 20% (ACR20) Response Rates Compare Against Core Baseline Through Week 82
American College of Rheumatology 50% (ACR50) Response Rates Compare Against Core Baseline Through Week 82
American College of Rheumatology 70% (ACR70) Response Rates Compare Against Core Baseline Through Week 82
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Arm 2: OKZ 64 mg q2w + MTXExperimental Treatment2 Interventions
Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Group II: Treatment Arm 1: OKZ 64 mg q4w + MTXExperimental Treatment2 Interventions
Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Concomitant treatment
2017
Completed Phase 3
~2110
Olokizumab 64 mg SC q4w
2017
Completed Phase 3
~2110
Olokizumab 64 mg SC q2w
2017
Completed Phase 3
~2110

Find a Location

Who is running the clinical trial?

R-PharmLead Sponsor
59 Previous Clinical Trials
12,221 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
310 Patients Enrolled for Rheumatoid Arthritis
IQVIA Pvt. LtdIndustry Sponsor
5 Previous Clinical Trials
893 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
17 Patients Enrolled for Rheumatoid Arthritis
R-Pharm International, LLCLead Sponsor
11 Previous Clinical Trials
3,106 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
2,461 Patients Enrolled for Rheumatoid Arthritis
~258 spots leftby Sep 2025
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