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NCT04333147 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,916
- Enrollment target
NCT04333147 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 2,916 participants.
The verdict
NCT04333147, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,916 participants
- Enrollment target
Study Summary
RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X \[209564: NCT04333147\]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) \[csDMARD(s)\] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study
Interventions
- BIOLOGICAL Otilimab (GSK3196165)
- DRUG csDMARD(s)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,916 participants |
| Start Date | 2020-05-12 |
| Est. Completion | 2023-02-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04333147
The ClinicalTrials.gov registry entry for NCT04333147 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2,916 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 2 interventions - of which Otilimab (GSK3196165) is the first listed.
NCT04333147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04333147 about?
NCT04333147 is a clinical study titled "Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)". RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and lon...
What is the current status of trial NCT04333147?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,916 participants. The study started on 2020-05-12. Estimated completion is 2023-02-24.
What interventions are being tested in trial NCT04333147?
The interventions under investigation include: Otilimab (GSK3196165) (BIOLOGICAL), csDMARD(s) (DRUG).
Who is sponsoring clinical trial NCT04333147?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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