A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
- Conditions
- Giant Cell ArteritisHorton DiseaseTemporal Arteritis10003816
- Registration Number
- NL-OMON45913
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
- Diagnose of Giant Cell Arteritis (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 * 30 mm/hour or C-reactive protein * 10 mg/L within 6 weeks of baseline.
- Receiving or able to receive prednisone 20-60 mg/day for the treatment of active GCA.
- 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.
- Prior treatment with any of the following:
> Janus kinase (JAK) inhibitor within 4 weeks of baseline.
> Cell-depletion agents 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 (TNF) inhibitors within 2 to 8 weeks of, or less than at least 5 half-lives have elapsed prior to, baseline, whichever is longer.
- Therapeutic failure with biological Interleukin 6/(R) (IL-6/(R) antagonist.
- Alkylating agents including cyclophosphamide within 6 months of baseline.
- Use of immunosuppressants, such as hydroxychloroquine (HCQ), cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide (LEF) within 4 weeks of baseline. (Use of 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 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 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 the study.
- Patients with a history of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients achieving sustained remission at Week 52.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Summary of the components of the sustained remission composite measure at Week<br /><br>52<br /><br>Total cumulative corticosteroid (including prednisone) dose over 52 weeks.<br /><br>Duration of first GCA flare from clinical remission up to Week 52.<br /><br>Changes from baseline in the glucocorticoid toxicity index and its components<br /><br>up to Week 52.<br /><br>Number of adverse events.<br /><br>Serum concentrations of sarilumab.</p><br>