Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

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.