EUCTR2017-002988-18-BE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 508
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •-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.
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