Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Intervention: Sarilumab SAR153191; Sarilumab matching placebo; Prednisone; Prednisone matching placebo
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: tablets or capsules Route of administration: oral administration; Pharmaceutical form: capsules Route of administration: oral administration
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

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).
    

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.