Trials / Terminated
TerminatedNCT03600805
Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
Study duration per participant was approximately 82 weeks, including an up to 6-week screening period, 52-week treatment period, and 24-week follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sarilumab SAR153191 | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| DRUG | Sarilumab matching placebo | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| DRUG | Prednisone | Pharmaceutical form: tablets or capsules Route of administration: oral administration |
| DRUG | Prednisone matching placebo | Pharmaceutical form: capsules Route of administration: oral administration |
Timeline
- Start date
- 2018-11-20
- Primary completion
- 2020-11-24
- Completion
- 2020-11-24
- First posted
- 2018-07-26
- Last updated
- 2022-03-28
- Results posted
- 2022-01-14
Locations
61 sites across 21 countries: United States, Argentina, Australia, Belgium, Canada, Croatia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Russia, Slovenia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03600805. Inclusion in this directory is not an endorsement.