EUCTR2005-002463-88-DE进行中（未招募）不适用
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
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Orfagen
- 入组人数
- 44
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,
- •Patients with a contra-indication or a major side-effect to prednisone or methotrexate / other IS,
- •Patients 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,
- •DM 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,
- •Patients 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:
- •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
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