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NCT03970837 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,764
- Enrollment target
NCT03970837 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 1,764 participants.
The verdict
NCT03970837, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,764 participants
- Enrollment target
Study Summary
This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study \[contRAst X (209564: NCT04333147)\]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.
Interventions
- DRUG Placebo
- DRUG Tofacitinib
- BIOLOGICAL GSK3196165 (Otilimab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,764 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970837
The ClinicalTrials.gov registry entry for NCT03970837 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,764 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03970837 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03970837 about?
NCT03970837 is a clinical study titled "Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)". This study \[contRAst 2 (201791: NCT03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an i...
What is the current status of trial NCT03970837?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,764 participants. The study started on 2019-06-05. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT03970837?
The interventions under investigation include: Placebo (DRUG), Tofacitinib (DRUG), GSK3196165 (Otilimab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03970837?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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