evaluation of efficacy and safety of sarilumab in patients with gca

Conditions: Giant Cell Arteritis

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).

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.

Eligibility criteria:
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.