Double-blind, randomized, placebo-controlled phase III study evaluating efficacy and safety of subcutaneous human immune globulin (Octanorm) in patients with dermatomyositis

Octapharma Pharmazeutika Produktionsges.m.b.H.0 个研究点目标入组 78 人开始时间: 2018年9月18日最近更新: 2019年1月14日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Octapharma Pharmazeutika Produktionsges.m.b.H.
入组人数: 78

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

入排标准

性别: All

入选标准

•1. Diagnosis of definite or probable DM according to the Bohan and Peter criteria
•2. Responded to IGIV (intravenous immunoglobulin) treatment as assessed by the treating physician and on a stable dose for at least 3 months on 2 g/kg bodyweight (+/- 10%).
•3. If on other medication(s) for the treatment of DM (immunosuppressants, corticosteroids):
•3.1. Receiving these medication(s) at the start of IGIV treatment in the first place
•3.2. Receiving these medication(s) for at least 3 months prior to study enrolment and at a stable dose for at least 4 weeks prior to study enrolment
•4. MMT-8 score =144, with at least 3 of the 5 other core set measures to be normal or near normal as per the following criteria:
•4.1. Visual Analogue Scale (VAS) of patient global disease activity =2 cm
•4.2. Physician’s global disease activity =2 cm,
•4.3. Extra-muscular disease activity =2 cm
•4.4. No muscle enzyme >4x upper limit of normal due to myositis
•4.5. Health Assessment Questionnaire (HAQ) =0.25.
•5. Aged =18 to <80 years
•6. Voluntarily given, fully informed written consent obtained from subject before any study-related procedures are conducted
•7. Capable and willing to understand and comply with the relevant aspects of the study protocol

排除标准

•1. Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 1 or 5 years, respectively, have passed since excision)
•2. Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors) or breast cancer diagnosed within the previous 10 years. Subjects >5 years (>10 years for breast cancer) of cancer diagnosis who have been treated and are in remission are allowed
•3. Overlap myositis (except for overlap with Sjögren’s syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis or drug-induced myopathy
•4. Immune-mediated necrotizing myopathy with absence of typical DM rash
•5. Generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician
•6. Received blood or plasma-derived products (other than IGIV) or plasma exchange within the last 3 months before enrolment
•7. Receiving permitted concomitant medications exceeding the maximally allowed conditions as above
•8. Received non-permitted concomitant medications within the washout periods
•9. Starting or planning to start a physical therapy–directed exercise regimen during the trial. Subjects on stable physical therapy for >4 weeks are allowed but the regimen should remain the same throughout the trial
•10. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
•11. Severe liver disease, with signs of ascites and hepatic encephalopathy
•12. Severe kidney disease (as defined by estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2)
•13. Known hepatitis B, hepatitis C or HIV infection
•14. History of deep vein thrombosis within the last year prior to study enrolment or pulmonary embolism ever
•15. Body mass index >40 kg/m2 and/or body weight >120 kg
•16. Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
•17. Known IgA deficiency with antibodies to IgA
•18. History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products or any component of Octanorm 16.5% such as polysorbate 80 or to sodium chloride
•19. Known blood hyperviscosity, or other hypercoagulable states
•20. Subjects with a history of drug abuse within the past 5 years prior to study enrolment
•21. Participating in another interventional clinical study with investigational treatment within 3 months prior to study enrolment. Subjects who participated in the Octagam 10% Dermatomyositis Study (GAM10-08) can be included
•22. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to apply an effective birth control method up to 4 weeks after the last Octagam infusion received

研究者

发起方

Octapharma Pharmazeutika Produktionsges.m.b.H.

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