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NCT03600818 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT03600818 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 118 participants.
The verdict
NCT03600818, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: * To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: * Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. * Cumulative CS (including prednisone) exposure. * To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. * To measure sarilumab serum concentrations in participants with PMR. * To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
Interventions
- DRUG Prednisone
- DRUG Sarilumab SAR153191 (REGN88)
- DRUG Sarilumab-matching placebo
- DRUG Prednisone-matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2018-10-09 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03600818
The ClinicalTrials.gov registry entry for NCT03600818 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Prednisone is the first listed.
NCT03600818 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03600818 about?
NCT03600818 is a clinical study titled "Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica". Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS taper...
What is the current status of trial NCT03600818?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2018-10-09. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT03600818?
The interventions under investigation include: Prednisone (DRUG), Sarilumab SAR153191 (REGN88) (DRUG), Sarilumab-matching placebo (DRUG), Prednisone-matching placebo (DRUG).
Who is sponsoring clinical trial NCT03600818?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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