Giant Cell Arteritis MedDRA version: 20.0 Level: LLT Classification code 10018250 Term: Giant cell arteritis System Organ Class: 100000004866
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 381
Exclusion criteria
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. -Use of immunosuppressant, such as hydroxychloroquine, cyclosporine, azathioprine,mycophenolate mofetil or leflunomide within 4 weeks of baseline. (Use of methotrexate (MTX) not exceeding 25 mg per week and have been stable for at least 3 months prior to baseline is not exclusionary). -Concurrent use of systemic corticosteroids (CS) for conditions other than GCA. -Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy. -Pregnant or breastfeeding woman. -Patients with active or untreated latent tuberculosis. -Patients with history of invasive opportunistic infections. -Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment. -Patients with uncontrolled diabetes mellitus. -Patients with non-healed or healing skin ulcers. -Patients who received any live, attenuated vaccine within 3 months of baseline. -Patients who are positive for hepatitis B, hepatitis C and/or HIV. -Patients with a history of active or recurrent herpes zoster. -Patients with a history of or prior articular or prosthetic joint infection. -Prior or current history of malignancy. -Patients who have had surgery within 4 weeks of screening or planned surgery during study. -Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients 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 patients 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 patients with GCA. -To measure sarilumab serum concentrations in patients with GCA. -To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).;Primary end point(s): Proportion of patients achieving sustained remission;Timepoint(s) of evaluation of this end point: Baseline to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Components of sustained remission (composite measure): Summary of the components of the sustained remission composite measure at Week 52 2. Cumulative corticosteroid dose: Total cumulative corticosteroid (including prednisone) dose over 52 weeks 3. Time to first GCA flare: Duration of first GCA flare from clinical remission up to Week 52 4. Change in glucocorticoid toxicity index: Changes from baseline in the glucocorticoid toxicity index and its components up to Week 52 5. Number of adverse events 6. Pharmacokinetic: Serum concentrations of sarilumab;Timepoint(s) of evaluation of this end point: 1. At Week 52 2. Up to Week 52 3. Up to Week 52 4. Up to Week 52 5. Up to Week 76 6. Up to Week 58 | — |
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed