NCT00802815已完成早期 1 期
Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles
研究概览
简要总结
Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients develop progressive weakness that may result in the need for assistive devices including a wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby blunting immune overactivation. Previous unblinded studies and case reports suggest that etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in slowing the progressive weakness in patients with IBM.
详细描述
Travel expenses not covered by the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of definite or probable IBM.
- •Male or female aged 18-
- •Subjects must be able to provide informed consent.
- •Subjects must be on no immunosuppressive medication for 3 months and agree not to take immunosuppressive medication during the study.
- •Subjects must not be on sulfasalazine
- •Subjects or caregivers must be able to administer SQ medication.
- •Women of childbearing potential (not postmenopausal or surgically sterile) must have a negative pregnancy test at screening and be using adequate birth control.
- •Absence of exclusion criteria.
排除标准
- •Exposure to etanercept within 3 months of study entry
- •Exposure to other investigational drugs within 3 months of study entry.
- •Subject with known hypersensitivity to etanercept.
- •Subject with active medical or psychiatric condition that in the opinion of the principal investigator, may affect the interpretation of the safety and efficacy data or which otherwise contraindicates participation in the study.
- •Signs, symptoms or laboratory evidence of severe renal, pulmonary, hepatic, neurologic, or cardiac (congestive heart failure, or coronary artery) disease, including creatinine > 2.0, LFT > 2x the upper limit of normal and hemoglobin < 12.5 (male) and < 11.0 (female).
- •Subject with weakness from any other neurological or neuromuscular disease, including multiple sclerosis or other CNS demyelinating disease.
- •Subject with sepsis or any active, chronic, or local infection or on antibiotic, antiviral or antifungal medication within 3 months prior to the first dose of Etanercept.
- •A prior history of tuberculosis and/or a positive PPD skin test at screening (including reading of borderline, reactive but non-diagnostic) or prior inoculated subjects.
- •Human immunodeficiency virus infection.
- •Subject with history of opportunistic infection.
- •Subject with a known history of anti-Jo-1, anti-SRP or anti-MI-2 antibodies.
- •The presence of an associated connective tissue disease, including systemic lupus erythematous, Sjögren's syndrome, scleroderma or mixed connective tissue disease.
- •History of a new diagnosis or treatment of invasive malignancy within 5 years of enrollment, including patients with a history of squamous cell carcinoma or basal cell carcinoma.
- •History of drug or alcohol abuse within 1 year prior to study entry.
- •Unwillingness to practice effective contraception, except for female patients who are post-menopausal or surgically sterile. The rhythm method is not to be used as the sloe method of contraception.
- •Subjects are not to receive live vaccines while in the study.
研究组 & 干预措施
Etanercept
Experimental
干预措施: Etanercept (Drug)
结局指标
主要结局
Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles
时间窗: 12 months
次要结局
未报告次要终点
研究者
Glenn Lopate
Associate Professor of Neurology
Washington University School of Medicine
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Cell Therapy for IBM by Muscle Injection of ADSVFInclusion Body MyositisNCT05032131Assistance Publique - Hôpitaux de Paris32
Unknown
不适用
Pharmacoepidemiologic General Research Extension: PGRx-sIBM StudySporadic Inclusion Body MyositisNCT02735447La-ser Europe Limited190
已完成
不适用
Lithium in Inclusion Body Myositis (IBM)Inclusion Body MyositisNCT00917956Phoenix Neurological Associates, LTD20
已完成
2 期
Arimoclomol in Sporadic Inclusion Body MyositisInclusion Body MyositisNCT00769860Richard Barohn, MD24
尚未招募
不适用
Clinical Study Cohort of Idiopathic Inflammatory MyositisIdiopathic Inflammatory MyopathiesNCT06306547RenJi Hospital1,000