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Monoclonal Antibodies

csDMARD(s) for Rheumatoid Arthritis (contRAst X Trial)

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
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 week 24, 48, 96 and 144
Awards & highlights

Summary

This trial is studying the long-term safety and effectiveness of GSK3196165, an injection for adults with rheumatoid arthritis. The participants have already shown benefits from this medication in earlier trials. GSK3196165 works by calming the immune system to reduce joint pain and swelling. The study will last several years and include around 3000 participants.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, 48, 96 and 144
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, 48, 96 and 144 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
+23 more
Secondary study objectives
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Absolute Values SF-36 Domain Scores
Absolute Values SF-36 Physical Component Scores (PCS)
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Otilimab 90 mgExperimental Treatment2 Interventions
Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.
Group II: Otilimab 150 mgExperimental Treatment2 Interventions
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,788 Previous Clinical Trials
8,173,891 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,275 Patients Enrolled for Rheumatoid Arthritis
Iqvia Pty LtdIndustry Sponsor
112 Previous Clinical Trials
170,717 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,601 Previous Clinical Trials
6,142,098 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
155 Patients Enrolled for Rheumatoid Arthritis
~547 spots leftby Sep 2025
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