NL-OMON45913已完成3 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis - EFC15068
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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.
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.
- •- 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.
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