EUCTR2017-002988-18-SE
Active, not recruiting
Phase 1
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi-Aventis Recherche & Développement
- Enrollment
- 508
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 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 (ESR) \=30 mm/hour or C\-reactive protein (CRP) \=10 mg/L within 6 weeks of baseline.
- •\-Receiving or able to receive prednisone 20\-60 mg/day for the treatment of active GCA.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 127
- •F.1\.3 Elderly (\>\=65 years) yes
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.
- •\-Any prior use of the following therapies, for the treatment of GCA:
- •\-Janus kinase inhibitor (e.g., tofacitinib) within 4 weeks of baseline.
- •\-Cell\-depletion agents (e.g., anti CD20\) 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 inhibitors within 2\-8 weeks (etanercept within 2 weeks; infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or less than at least 5 half\-lives have elapsed prior to baseline, whichever is longer.
- •\-Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL\-6/(R) antagonist (prior experience with IL\-6/(R) antagonist that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
- •\-Use of any alkylating agents including cyclophosphamide within 6 months of baseline.
Outcomes
Primary Outcomes
Not specified
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