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 International Corporation0 个研究点目标入组 150 人开始时间: 2019年2月11日最近更新: 2021年12月21日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Bristol-Myers Squibb International Corporation
入组人数: 150

研究概览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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•a) Diagnosis of Definite or Probable IIM (DM or PM) using the Bohan and Peter classification criteria
•i) 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 myositis-specific autoantibody
•ii) Subjects with a diagnosis of IIM other than dermatomyositis include PM, autoimmune necrotizing myopathy, myositis in association with another connective tissue disease (overlap myositis) and juvenile myositis subjects above the age of 18. These subjects
•must have a prior muscle biopsy diagnostic for IIM or a prior positive test for at least one myositis-specific autoantibody (anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS), anti-Mi-2, anti-SRP, anti-TIF1-y, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR). For subjects with overlap myositis, the myositis must be the principal clinically active manifestation of their disease.
•iii) Myositis-specific autoantibodies include the anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS), anti-Mi-2, anti-SRP, anti-TIF1-c, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR
•iv) Where applicable, documentation of prior skin biopsy, muscle biopsy, and autoantibody results must be obtained and retained by the site
•b) Demonstrable muscle weakness measured by the MMT-8 of = 135 units and any 3 of the following:
•i) MMT-8 = 125 units
•ii) Physician’s global assessment (PGA) VAS = 2 cm
•iii) Subject’s global assessment (SGA) VAS = 2 cm
•iv) HAQ-DI = 0.5
•v) One or more muscle enzyme (CK, aldolase, LDH, AST, ALT) = 1.3 times upper limit of normal (ULN)
•vi) MDAAT Extramuscular Global Activity VAS = 2 cm
•c) Demonstration of currently active IIM will be determined by an adjudication committee unless the subject has any one of the following:
•i. an active myositis-associated rash (Gottron’s papules or heliotrope rash), or
•ii. a recent (within 3 months prior to signing informed consent) biopsy, magnetic resonance imaging (MRI) or electromyogram (EMG) demonstrating active disease, or
•iii. an elevated CK > 5 times the upper limit of normal at screening with no alternate explanation or cause
•d) Active disease despite adequate prior treatment experience with corticosteroids, immunosuppressants, or biologics as determined by the investigator
•e) The subject must be on background standard treatment for IIM. The standard treatments that are allowed as background treatment for IIM includes:
•i. Corticosteroids alone, or
•ii. One of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or
•iii. A combination of corticosteroids and one of the above immunosuppressants
•If using corticosteroids for IIM, the subject must have been on corticosteroids for at least 12 weeks prior to randomization and a stable dose of corticosteroids for at least 4 weeks prior to randomization.
•If using immunosuppressants other than azathioprine, the subject must have been on a stable dose of the same medication for at least 12 weeks and a stable dose for at least 4prior to randomization.
•If using azathioprine, the subject must have been on azathioprine for at least 24 weeks with a stable dose for at least 12 weeks prior to randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-6

排除标准

•a) Subjects with Inclusion Body Myositis,or myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.
•b) Subjects treated with penicillamine or zidovudine in the past 3 months
•c) Subjects treated with rituximab in the 6 months prior to randomization (there must be laboratory results indicating the presence of circulating B cells (CD19+). Any other biologic treatment in the past 3 months or immune globulin (intravenous [IVIG] or subcutaneous [SCIG] in the past 3 months prior to randomization.
•d) Subjects with uncontrolled or rapidly progressive interstitial lung disease
•e) Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
•f) Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer). See criteria (2i)
•g) Subjects who are known to be positive for the anti-TIF-y (p155/140) autoantibody prior to randomization who were diagnosed with IIM < 1 year prior to randomization.
•h) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections
•i) 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). Additional screening recommandations for malignancy are outlined in Sections 3.3.2 and 3.3.4.

研究者

发起方

Bristol-Myers Squibb International Corporation

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