EUCTR2005-003956-37-BE进行中（未招募）不适用
Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial
niversity Hospital Gent0 个研究点目标入组 180 人开始时间: 2006年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •Inclusion Criteria. Each patient must meet all the following criteria in order to participate in
- •this trial:
- •1) Newly diagnosed and untreated children (only treatment with 1 NSAID is allowed
- •and/or prednisone >1 mg/kg/day for no more than 1 month from diagnosis) with
- •probable or definite diagnosis of JDM according to the Bohan and Peter criteria (12;13). If a muscle biopsy will be performed (optional) it will be read by the pathologists of the participating centres (light and immunofluorescence). Slides of paraffin-embedded sections from all patients will be re-viewed by a blinded myopathologist at PRINTO.
- •2) Age at enrolment = 18 years.
- •3) Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial, and then every 3 months. If sexually active, they must agree to use adequate contraception, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use adequate birth control methods if sexually active.
- •4) Ability to comply with the entire study procedures, ability to communicate
- •meaningfully with the investigational staff, competence to give written informed
- •consent; to be applied to the parents and/or patients, as appropriate
- •5) Duly executed, written, informed consent obtained from the parents/patient.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria. Any of the following will exclude a patient from this trial:
- •1) Neutrophil count <1,500/mm3 and/or platelet count <50,000/mm3
- •2) Demonstration of cutaneous or gastrointestinal ulceration of JDM related
- •pulmonary disease or cardiomyopathy at the time of diagnosis.
- •3) History of poor compliance.
- •4) Evidence of current use of alcohol or illicit drugs abuse.
- •5) Live vaccines not allowed during the entire duration of the trial.
研究者
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