Resumen

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).

Descripción detallada

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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Sarilumab SAR153191

Pharmaceutical form: solution for injection Route of administration: subcutaneous

drug

Sarilumab matching placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

drug

Prednisone

Pharmaceutical form: tablets or capsules Route of administration: oral administration

drug

Prednisone matching placebo

Pharmaceutical form: capsules Route of administration: oral administration

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sarilumab SAR153191

Sarilumab matching placebo

Prednisone

Prednisone matching placebo

Ubicaciones

Investigational Site Number 0320001

Investigational Site Number 0320002

Patrocinadores