EUCTR2016-002902-37-HU进行中（未招募）1 期
PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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 under treatment with corticosteroids and/or maximally 2 immune-suppressants and
- •3. Subjects with active disease, assessed and agreed upon by an independent adjudication committee. being on stable therapy for at least 4 weeks.
- •4. Manual Muscle Testing-8 (MMT-8) score <142, with at least 2 other abnormal Core Set Measures (CSM) (Visual Analogue Scale [VAS] of patient global activity =2 cm, physician’s global disease activity =2 cm, extra-muscular activity =2 cm; at least one muscle enzyme >1.5 times upper limit of normal, Health Assessment Questionnaire =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 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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •1.Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
- •2. Subjects under treatment with corticosteroids and/or maximally 2 immune-suppressants and
- •3. Subjects with active disease, assessed and agreed upon by an independent adjudication committee. being on stable therapy for at least 4 weeks.
- •4. Manual Muscle Testing-8 (MMT-8) score <142, with at least 2 other abnormal Core Set Measures (CSM) (Visual Analogue Scale [VAS] of patient global activity =2 cm, physician’s global disease activity =2 cm, extra-muscular activity =2 cm; at least one muscle enzyme >1.5 times upper limit of normal, Health Assessment Questionnaire =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 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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
- •1.Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
- •2. Subjects under treatment with corticosteroids and/or maximally 2 immune-suppressants and
- •3. Subjects with active disease, assessed and agreed upon by an independent adjudication committee. being on stable therapy for at least 4 weeks.
- •4. Manual Muscle Testing-8 (MMT-8) score <142, with at least 2 other abnormal Core Set Measures (CSM) (Visual Analogue Scale [VAS] of patient global activity =2 cm, physician’s global disease activity =2 cm, extra-muscular activity =2 cm; at least one muscle enzyme >1.5 times upper limit of normal, Health Assessment Questionnaire =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 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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 5 years 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.
- •3. Subjects with overlap myositis (except for overlap with Sjögren’s syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis 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 have received IgG treatment within the last 6 months before enrolment.
- •7. Subjects who received blood or plasma-derived products (other than IgG) or plasma exchange within the last 3 months before enrolment.
- •8. Subjects starting or planning to start a physical therapy–directed exercise regimen during the trial.
- •9. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease.
- •10. Severe liver disease, e.g. hepatitis or cirrhosis.
- •11. Severe kidney disease (creatinine 1.5 times above the upper limit of normal).
- •12. Known hepatitis B, hepatitis C or HIV infection.
- •13. Subjects with a history of deep vein thrombosis within the last year prior to study enrollment or pulmonary embolism ever.
- •14. Body mass index =40 kg/m2.
- •15. Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
- •16. Known IgA deficiency with antibodies to IgA.
- •17. History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products or any component of Octagam 10%.
- •18. Known blood hyperviscosity, or other hypercoagulable states.
- •19. Subjects with a history of drug abuse within the past 5 years prior to study enrollment.
- •20. Subjects unable or unwilling to understand or comply with the study protocol.
- •21. Participating in another interventional clinical study with investigational treatment within 3 months prior to study enrollment.
- •22. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to apply an effective birth control method while on study.
- •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 5 years 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.
- •3. Subjects with overlap myositis (except for overlap with Sjögren’s syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis 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 have received IgG treatment within the last 6 months before enrolment.
- •7. Subjects who received blood or plasma-derived products (other than IgG) or plasma exchange within the last 3 months before enrolment.
- •8. Subjects starting or planning to start a physical therapy–directed exercise regimen during the trial.
- •9. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease.
- •10. Severe liver disease, e.g. hepatitis or cirrhosis.
- •11. Severe kidney disease (creatinine 1.5 times above the upper limit of normal).
- •12. Known hepatitis B, hepatitis C or HIV infection.
- •13. Subjects with a history of deep vein thrombosis within the last year prior to study enrollment or pulmonary embolism ever.
- •14. Body mass index =40 kg/m2.
- •15. Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
- •16. Known IgA deficiency with antibodies to IgA.
- •17. History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products or any component of Octagam 10%.
- •18. Known blood hyperviscosity, or other hypercoagulable states.
- •19. Subjects with a history of drug abuse within the past 5 years prior to study enrollment.
- •20. Subjects unable or unwilling to understand or comply with the study protocol.
- •21. Participating in another interventional clinical study with investigational treatment within 3 months prior to study enrollment.
- •22. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to apply an effective birth control method while on study.
- •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 5 years 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.
- •3. Subjects with overlap myositis (except for overlap with Sjögren’s syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis 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 have received IgG treatment within the last 6 months before enrolment.
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