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Monoclonal Antibodies
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (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
No Placebo-Only Group
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24, 48, 96 and 144
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24, 48, 96 and 144
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 moreSecondary 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
4,812 Previous Clinical Trials
8,379,332 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
2,275 Patients Enrolled for Rheumatoid Arthritis
Iqvia Pty LtdIndustry Sponsor
118 Previous Clinical Trials
173,914 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,142,155 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
155 Patients Enrolled for Rheumatoid Arthritis