Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study. - IMMEDIATE

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•* Adult patients (age * 18 years);* Subacute-onset of disease (disease duration of * 9 months) of muscle symptoms;* Biopsy proven IIMs (see for diagnostic criteria Hoogendijk et al. 2004, note: ASS is considered a separate entity, but new criteria in which it has been included, has yet to be published).
•o Dermatomyositis
•o Non-specific myositis/antisynthetase syndrome
•o Immune-mediated necrotizing myopathy;* Minimal disability of:
•o MMT score reduction of 10% or lower and,
•o 2 other of the core set measures score abnormalities defined as:
•- Physician Global Activity 2 cm or more
•- Patient Global Activity 2 cm or more
•- Health Assessment Questionnaire 0.25 or more
•- Muscle enzymes more than 1.5 times upper limit of normal
•- Extra-Muscular Activity 2 cm or more

•* IVIg treatment related:
•o Subjects who have received clinical relevant immunosuppressive medication (e.g. plasmapheresis, biologicals, immune therapy etc.) within the last 6 months with the exception of prednisone dosed as follows:
•* daily dose of 20mg or lower
•* used for 2 weeks or less
•* no evident clinical response;o history of thrombotic episodes within the 2 years prior to enrolment
•o known allergic reactions or other severe reactions to any blood-derived product
•o known IgA deficiency and anti-IgA serum antibodies
•o pregnancy (wish).;* Conditions that are likely to interfere with:
•o compliance (legal incompetent and/or incapacitated patients are excluded) or,
•o evaluation of efficacy (e.g. due to severe pre-existing disability as result of any other disease than IIM or language barrier).;* Lack of informed consent (IC)

发起方