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

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

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

Awards & 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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