EUCTR2017-002710-31-HU进行中（未招募）1 期
DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 78
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
- •1. Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
- •2. Subjects who have responded to IGIV treatment as assessed by the treating physician and being on a stable dose for at least 3 months on 2 g/kg bodyweight (+/- 10%) prior to study enrolment.
- •3. For subjects being on other medication(s) for the treatment of DM (immunosuppressants, corticosteroids): a) subject was on such medication(s) at the start of IGIV treatment in the first place, and b) received such 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 at the maximally allowed conditions as per Table 2 (see section 4.2.1).
- •4. MMT-8 score =144, with at least 3 other CSM to be normal or near normal as per the following criteria: Visual Analogue Scale [VAS] of patient global disease activity
- •=2 cm, physician’s global disease activity =2 cm, extra-muscular disease activity =2 cm; no muscle enzyme >4 times upper limit of normal due to myositis, Health Assessment Questionnaire [HAQ] =0.25.
- •5. Males or females 18 to <80 years of age.
- •6. Voluntarily given, fully informed written consent obtained from subject before any study-related procedures are conducted.
- •7. Subject must be capable and willing to understand and comply with the relevant aspects of the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
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 at least 1 year for basal or squamous cell skin cancer and 5 years for carcinoma in situ of the cervix must have passed since excision).
- •2-Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors).
- •3-Subjects with overlap myositis connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile dermatomyositis or drug-induced myopathy.
- •4-Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.
- •5-Subjects with generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician.
- •6-Subjects who received blood or plasma-derived products (other than IGIV) or plasma exchange within the last 3 months before enrolment.
- •7-Subjects with administration of permitted concomitant medications exceeding the maximally allowed conditions as per section 4.2.1
- •8-Subjects with administration of forbidden concomitant medications within the washout periods as defined in Table 3
- •9-Subjects 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).
- •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 active or chronic hepatitis B, hepatitis C or HIV infection. Past hepatitis B or C infection that has been cured is allowed.
- •14-Subjects with a history of deep vein thrombosis within the last year prior to study enrolment or pulmonary embolism.
- •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.
- •17-Known IgA deficiency with antibodies to IgA.
- •18-History of hypersensitivity, anaphylaxis or severe systemic response to immuno- globulin, 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 except study GAM10-08.
- •22-Women who are breast feeding, pregnant, or planning to become pregnant during study.
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