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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: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT04333147 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 2,916 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (278% higher). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Pr
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 |
Why NCT04333147 stopped before completion
NCT04333147 is an interventional study that assigns participants to a tested intervention. Its 2,916 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (278% higher).
The record links to 0 conditions, and to 2 interventions - of which Otilimab (GSK3196165) is the first listed.
NCT04333147 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04333147's enrollment target sits among peer trials
2,916 80th of 2000 higher than 1,921 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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