NL-OMON45913
Completed
Phase 3
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis - EFC15068
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi-aventis
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diagnose of Giant Cell Arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology classification criteria.
- •\- New onset active disease or refractory active disease.
- •\- At least one of the symptoms of GCA within 6 weeks of baseline.
- •\- Either erythrocyte sedimentation rate \* 30 mm/hour or C\-reactive protein \* 10 mg/L within 6 weeks of baseline.
- •\- Receiving or able to receive prednisone 20\-60 mg/day for the treatment of active GCA.
Exclusion Criteria
- •\- Organ transplantation recipient (except corneas, unless it is within 3 months prior to baseline visit).
- •\- Major ischemic event, unrelated to GCA, within 12 weeks of screening.
- •\- Prior treatment with any of the following:
- •\> Janus kinase (JAK) inhibitor within 4 weeks of baseline.
- •\> Cell\-depletion agents without evidence of recovery of B cells to baseline level.
- •\> Abatacept within 8 weeks of baseline.
- •\> Anakinra within 1\-week of baseline.
- •\> Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks of, or less than at least 5 half\-lives have elapsed prior to, baseline, whichever is longer.
- •\- Therapeutic failure with biological Interleukin 6/(R) (IL\-6/(R) antagonist.
- •\- Alkylating agents including cyclophosphamide within 6 months of baseline.
Outcomes
Primary Outcomes
Not specified
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Phase 1
Evaluation of Efficacy and Safety of Sarilumab in Patients with GCAGiant Cell ArteritisMedDRA version: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2017-002988-18-BESanofi-Aventis Recherche & Développement508