A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)

Bristol-Myers Squibb K.K.0 个研究点目标入组 150 人开始时间: 2017年8月9日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Bristol-Myers Squibb K.K.
入组人数: 150

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment

入排标准

年龄范围: >= 18age old 至 ot applicable（—）
性别: All

入选标准

•Diagnosis of IIM based on the Bohan and Peter classification criteria:
•1) Subjects with dermatomyositis (DM) must also have a confirmed myositis-associated rash (Gottron's papules or a heliotrope rash preferably confirmed by skin biopsy) or a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody; 2) Subjects with IIM other than DM (PM, autoimmune necrotizing myopathy, myositis associated with other autoimmune connective diseases (overlap myositis), or juvenile myositis with age over 18 years) must also have a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody
•Demonstrable muscle weakness measured by the MMT-8 of under 135 units and any 3 of the following: 1) MMT-8 under 125 units; 2) Physician's global assessment (PGA) visual analog scale (VAS) over 2 cm; 3) Subject's global assessment (SGA) VAS over 2 cm; 4) HAQ-DI over 0.5; 5) One or more muscle enzyme (CK, aldolase, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), ALT) over 1.3 times upper limit of normal (ULN); 6) MDAAT Extramuscular Global Activity VAS over 2 cm
•Demonstration of currently active IIM will be determined by an adjudication committee unless the subject has any one of the following: 1) an active myositis-associated rash (Gottron's papules or heliotrope rash), or 2) a recent (within 1 month prior to signing informed consent) biopsy, magnetic resonance imaging (MRI), or electromyogram (EMG) demonstrating active disease, or 3) an elevated CK over 5 times the upper limit of normal
•Active disease despite prior treatment with corticosteroids, immunosuppressants, or biologics as determined by the investigator
•The subject must be on background standard treatment for IIM. The standard treatments that are allowed as background treatment for IIM includes: 1) Corticosteroids alone, or 2) One of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or 3) A combination of corticosteroids and one of the above immunosuppressants. The subject must have been on the same medication(s) for IIM for 12 weeks prior to randomization and the dose must have been stable for 4 weeks prior to randomization.

排除标准

•Subjects with Inclusion Body Myositis (IBM), or myositis other than IIM, eg, drug-induced myositis and PM associated with HIV
•Subjects treated with penicillamine or zidovudine in the past 3 months
•Subjects treated with rituximab in the past year or any other biologic treatment or Intravenous Immunoglobulin (IVIG) in the past 6 months.
•Subjects with uncontrolled or rapidly progressive interstitial lung disease
•Subjects with severe muscle damage (Myositis Damage Index over 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
•Subjects at risk for tuberculosis
•Subjects with recent acute infection requiring antibiotics
•Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections
•Subjects who have a present malignancy or have had a previous malignancy within the last 5 years prior to screening (except for a documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).

研究者

发起方

Bristol-Myers Squibb K.K.

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