Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study.

ORFAGE0 个研究点目标入组 44 人开始时间: 2006年4月21日最近更新: 2013年1月7日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 44

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•- Male or female patients of at least 18 years of age - Patients fulfilling the diagnostic criteria (definite or probable) of the European Neuro-Muscular Committee (ENMC) for idiopathic DM and PM.- Patients with an active DM or PM disease who received conventional therapies for at least 14 weeks: prospective or clearly-documented retrospective administration of oral prednisone 1mg/Kg per day for at least 4 weeks, with or without IS, followed by IS at stable dose (methotrexate MTX 15-50 mg per week, or other IS) and prednisone for at least 10 weeks, OR Patients with a contra-indication or a major side-effect to prednisone or methotrexate / other IS,ORPatients under bitherapy (prednisone and MTX / other IS) with a documented deterioration of their BMRC score, as follows:`· Of at least 18 points if BMRC at the beginning of the run-in period over 56`· Of at least 12 points if BMRC at the beginning of the run-in period between 40.5 and 56 included`· Of at least 8 points if BMRC at the beginning of the run-in period below 40.5,ORDM patients under bitherapy (prednisone and MTX / other IS) having a documented deterioration of their cutaneous signs, as follows:`· Cutaneous signs aggravated (score from 0 or 1 to 2)`· Cutaneous signs of 2 at two consecutive visits, ORPatients under bitherapy (prednisone and MTX / other IS) with an onset of visceral involvement (e.g. pharyngeal, pulmonary, cardiac).- Patients with no significant improvement of muscle strength under conventional therapy, as follows:`· Less of 8 points if BMRC score over 56 at the beginning of the run-in period `· Less of 12 points if BMRC score between 40.5 and 56 at the beginning of the run-in period `· Less of 18 points if BMRC score below 40.5 at the beginning of the run-in period.- Patients with BMRC index between 24 and 72 at baseline.- For French centres, patients affiliated to the French Security System.- Patients able to follow instructions.- Written informed consent from the patients.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•- Pregnant women, nursing mothers and women of childbearing potential with no reliable contraception.- Patients who do not fulfill the ENMC diagnostic criteria (definite or probable) of idiopathic DM and PM.- Patients with a diagnosis of paraneoplasic DM or PM.- Juvenile DM and PM (age less than 18 years).- DM patients with no muscle involvement.- Patients with life expectancy of less than 3 months.- Patients whose muscle strength is responsive to conventional therapy, i.e. with the following BMRC improvement of at least:`· 18 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC below 40,5 at first run-in period assessment`· . 12 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC between 40.5 and 56 included at first run-in period assessment`· 8 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC over 56 at first run-in period assessment- Patients with an BMRC index of less than 24 or more than 72.- Patients having received a bolus of methylprednisone within 3 weeks prior to study entry.- Patients with a known allergy to one of the ingredients of the IVIg test product.- Patients with decompensated cardiac insufficiency or any other intercurrent condition that may alter the study conduct.- Patients with positive Coomb`s test at baseline.- Patients who refuse to participate in the study.- Patients who are not able to follow instructions.- Patients who are protected by the law (guardianship, trusteeship).- Patients who have participated in a study within the 3 months prior to study run-in period.- Patients who refuse to give written informed consent.

研究者

发起方

ORFAGE

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