NCT02971683已完成3 期
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 Squibb79 个研究点 分布在 7 个国家目标入组 149 人开始时间: 2017年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 79
- 主要终点
- Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
研究概览
简要总结
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IIM based on 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) and 2 or more of the remaining 4 criteria.
- •ii) Subjects with a diagnosis of IIM other than DM include PM, autoimmune necrotizing myopathy, myositis in association with another connective tissue disease (overlap myositis) and juvenile myositis subjects above the age of
- •These subjects must have a prior muscle biopsy diagnostic for IIM or a 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-g, 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. Where applicable, documentation of prior skin biopsy, muscle biopsy, and autoantibody results must be obtained and retained by the site.
- •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) visual analog scale (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) ³ 1.3 times upper limit of normal (ULN); vi) MDAAT Extramuscular Global Activity VAS ≥2 cm
- •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
- •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: 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. 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. 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.
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 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
- •Subjects with uncontrolled or rapidly progressive interstitial lung disease
- •Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
- •Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer
- •Subjects who are known to be positive for the anti-TIF-1 (p155/140) autoantibody prior to randomization who were diagnosed with IIM < 1 year prior to randomization.
- •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).
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Abatacept subcutaneous + Standard Treatment
Active Comparator
Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
干预措施: Abatacept subcutaneous (Drug)
Placebo of Abatacept subcutaneous + Standard Treatment
Placebo Comparator
Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
时间窗: From first dose to 24 weeks after first dose. (Approximately 169 days)
The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24. The IMACS DOI is: An improvement of \>/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by \>/= 25% from baseline. IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
次要结局
- Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24(From first dose to 24 weeks after first dose. (Approximately 169 days))
- Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period(From first dose up to approximately 56 days post last dose (up to approximately 54 months))
- Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period(From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days))
- Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Cumulative Abatacept Period(From first dose up to approximately 56 days post last dose (up to approximately 54 months))
- Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24(From first dose to 24 weeks after first dose. (Approximately 169 days))
- Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24(From first dose to 24 weeks after first dose. (Approximately 169 days))
- Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period(From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days))
- Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24(From first dose to 24 weeks after first dose. (Approximately 169 days))
- Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period(From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days))
- Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period(From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days))
- Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period(From first dose up to approximately 56 days post last dose (up to approximately 54 months))
- Number of Participants Experiencing Laboratory Test Abnormalities in the Long-Term Open Label Period(From first dose in the Long-Term Open Label Period up to 56 days post last dose in the Long-Term Open Label Period (up to approximately 958 days))
- Number of Participants Experiencing Laboratory Test Abnormalities in the Open-Label Period(From first dose in open label period to first dose date in the subsequent period or up to 56 days post last dose (up to approximately 666 days))
研究者
研究点 (79)
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