Evaluation of Efficacy and Safety of Sarilumab in Patients with GCA

Phase 1

• Conditions: Giant Cell Arteritis; MedDRA version: 20.0Level: LLTClassification code 10018250Term: Giant cell arteritisSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-002988-18-SE
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

-Diagnosis of giant cell arteritis (GCA) according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 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 (ESR) =30 mm/hour or C-reactive protein (CRP) =10 mg/L within 6 weeks of baseline.
-Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 381

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 have elapsed prior to baseline, whichever is longer.
-Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological 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 is 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 have been stable for at least 3 months prior to baseline is not exclusionary).
-Concurrent use of systemic corticosteroids (CS) for conditions other than GCA.
-Use of IV CS at a dose equivalent to 100 mg of methylprednisolone or higher within 8 weeks of baseline for GCA therapy.
-Pregnant or breastfeeding woman.
-Patients with active or untreated latent tuberculosis.
-Patients with history of invasive opportunistic infections.
-Patients with fever associated with infection or chronic, persistent or recurring infections requiring active treatment.
-Patients with uncontrolled diabetes mellitus.
-Patients with non-healed or healing skin ulcers.
-Patients who received any live, attenuated vaccine within 3 months of baseline.
-Patients who are positive for hepatitis B, hepatitis C and/or HIV.
-Patients with a history of active or recurrent herpes zoster.
-Patients with a history of or prior articular or prosthetic joint infection.
-Prior or current history of malignancy.
-Patients who have had surgery within 4 weeks of screening or planned surgery during study.
-Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified