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Sponsor: Sanofi
Conditions: Giant Cell Arteritis
Interventions: Sarilumab SAR153191, Sarilumab matching placebo, Prednisone, Prednisone matching placebo
Countries: United States, Argentina, Australia, Belgium, Canada, Croatia, Denmark, Estonia
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).
Sex: ALL
Age: 50 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria : * Diagnosis of 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 greater than or equal to (\>=) 30 millimeter per hour or C-reactive protein \>=10 mg per liter within 6 weeks of baseline. * Received or were 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. * 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 had elapsed prior to baseline, whichever was longer. * Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological Interleukin 6 (IL-6) 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 was 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 had been stable for at least 3 months prior to baseline was not exclusionary). * Concurrent use of systemic CS for conditions other than GCA. * Use of intervascular CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy. * Pregnant or breastfeeding woman. * Participants with active or untreated latent tuberculosis. * Participants with history of invasive opportunistic infections. * Participants with fever associated with infection or chronic, persistent or recurring infections requiring active treatment. * Participants with uncontrolled diabetes mellitus. * Participants with non-healed or healing skin ulcers. * Participants who received any live, attenuated vaccine within 3 months of baseline. * Participants who are positive for hepatitis B, hepatitis C and/or HIV. * Participants with a history of active or recurrent herpes zoster. * Participants with a history of or prior articular or prosthetic joint infection. * Prior or current history of malignancy. * Participants who have had surgery within 4 weeks of screening or planned surgery during study. * Participants with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
- Boca Raton, Florida, United States
- Gainesville, Florida, United States
- Iowa City, Iowa, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Buenos Aires, Argentina
- Caba, Argentina
- Camberwell, Australia
- Clayton, Australia
- Kogarah, Australia
- Leuven, Belgium
- Hamilton, Canada
- Montreal, Canada
- Rimouski, Canada
- Sherbrooke, Canada
- Trois-Rivières, Canada
- Zagreb, Croatia
- Aarhus C, Denmark
- Svendborg, Denmark
- Tallinn, Estonia
- Brest, France
- Montivilliers, France
- Montpellier, France
- Mulhouse, France
- Paris, France
- Pessac, France
- Berlin, Germany
- Dresden, Germany
- Kirchheim unter Teck, Germany
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