Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03600805 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT03600805 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 83 participants.
The verdict
NCT03600805, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: * Clinical responses (such as responses based on 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 GCA. * To measure sarilumab serum concentrations in participants with GCA. * To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).
Interventions
- DRUG Prednisone
- DRUG Sarilumab SAR153191
- DRUG Sarilumab matching placebo
- DRUG Prednisone matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03600805
The ClinicalTrials.gov registry entry for NCT03600805 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 83 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.
NCT03600805 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03600805 about?
NCT03600805 is a clinical study titled "Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA". Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: * To d...
What is the current status of trial NCT03600805?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2018-11-20. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT03600805?
The interventions under investigation include: Prednisone (DRUG), Sarilumab SAR153191 (DRUG), Sarilumab matching placebo (DRUG), Prednisone matching placebo (DRUG).
Who is sponsoring clinical trial NCT03600805?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.