EUCTR2006-000078-65-GB进行中（未招募）1 期
Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis
Karolinska University Hospital0 个研究点目标入组 202 人开始时间: 2010年12月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
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.Adults with definite or probable DM or PM and pediatric patients five years of age and over with definite or probable JDM by the criteria of Bohan and Peter [33] (See Appendix C). Patients without the rash of DM will require a muscle biopsy (not necessarily done at enrollment) compatible with PM as determined by an experienced muscle pathologist. In order to be enrolled with a diagnosis of refractory PM, patients’ medical information will be reviewed and the diagnosis confirmed by a 3-member Adjudication Committee consisting of 3 Steering Committee members/Investigators. This adjudication process is necessary to exclude mimics of polymyositis including but not limited to inclusion body myositis, toxic or metabolic myopathies and adult onset muscular dystrophies.
- •2.A diagnosis of JDM based on an age of onset (i.e. first symptom of myositis or the rash of dermatomyositis) < 18 years of age.
- •3.Disease duration > 6 months from diagnosis of myositis.
- •4.Refractory myositis as defined by the intolerance to or an inadequate response to corticosteroids plus an adequate regimen of at least one other IS agent such as azathioprine, methotrexate, IVIg, mycophenolate mofetil, cyclophosphamide, tacrolimus or cyclosporine A. The definition of intolerance is: side effects that require discontinuation of the medication or an underlying condition that precludes the further use of the medication.
- •An adequate corticosteroid treatment trial is as follows:
- •Adult IIM: prednisone (or an equivalent corticosteroid) at a dose of at least 60 mg/day for one month
- •JDM: 1.0mg/kg/day prednisone for at least one month
- •5.Baseline manual muscle testing which is based on a maximum MMT-8 score of 150 (see Appendix D): Subjects must have a score that is no greater than 125/150 in conjunction with 2 other abnormal core set measures; abnormal core set measures include the following:
- •Patient/Parent global VAS with a minimum value of 2.0cm on a 10cm scale
- •MD global VAS with a minimum value of 2.0cm on a 10cm scale
- •CHAQ/HAQ disability index with a minimum value of 0.25
- •Elevation of at least one of the muscle enzymes [which includes creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] at a minimum level of 1.3 x the upper limit of normal.
- •If more than one muscle enzyme is identified as being elevated and meeting the above guidelines then the most abnormal will be selected and this enzyme will be the target enzyme followed to evaluate disease improvement or worsening.
- •Global extramuscular disease activity score with a minimum value of 1.0cm on a 10cm VAS scale (this measure is the physician’s composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiac scales of the Myositis Disease Activity Assessment Tool (MDAAT) - see Appendix D
- •6.If on prednisone, the dose must be stable for 4 weeks prior to the screening visit (recommend = 1.0 mg/kg/day).
- •7.Background therapy with at least 1 non-corticosteroid immunosuppressive agent is required at a stable dose for at least 6 weeks prior to the screening visit.
- •The IS agents include: methotrexate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide or mycophenolate mofetil.
- •8.If an IS agent was discontinued prior to the screening visit then there must be a:
- •4 week washout
排除标准
- •1.Drug-induced myositis (myositis in patients taking medications known to induce myositis-like syndromes, including, but not limited to, statin agents, fibric acid derivatives, colchicine, and hydroxychloroquine).
- •2.Use of colchicine during study participation is not allowed.
- •3.Juvenile polymyositis; inclusion body myositis; 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 if at least 5 years since excision
- •4.Myositis in overlap with another connective tissue disease (CTD) that precludes the accurate assessment of a treatment response (the 3-member committee discussed under Inclusion Criteria #1 above will also determine the eligibility of such patients with myositis and an associated CTD).
- •5.History of receiving a live vaccine 4 weeks prior to initiation of study treatment
- •6.Joint disease or other musculoskeletal condition, which precludes the ability to quantitate muscle strength.
- •7.Known hypersensitivity to murine proteins.
- •8.Concomitant illness that would prevent adequate patient assessment or pose an added risk for study participants:
- •recurrent or chronic infections, including HIV, hepatitis B and C
- •known liver disease (i.e. cirrhosis or other conditions compromising the synthetic function of the liver)
- •disorders that would preclude accurate assessment of neuromuscular function
- •cardiomyopathy/congestive heart failure/arrhythmia (or New York Heart Classification III or IV disease)
- •psychiatric illness that precludes compliance or neuromuscular assessment
- •serum creatinine > 2.0mg/dl
- •IgG or IgM levels at baseline that are below the normal range (for pediatrics age adjusted normal ranges will be followed)
- •9.Pregnant females or nursing mothers
- •10.Life threatening non-myositis illness that would interfere with the patient’s ability to complete the study.
- •11.Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview
- •12.Anticipated poor compliance
- •13.Participation in another clinical (experimental) study within 30 days of screening visit.
- •14.Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study.
- •15.Any history of receiving rituximab
- •16.Evidence of prior infection of Hepatitis B and Hepatitis C
- •17.Initiation of an exercise program within 4 weeks of screening visit or initiation of an exercise program during the study (See section 5.4 Other Restrictions)
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