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

Academic Medical Center0 个研究点目标入组 20 人开始时间: 2016年12月21日最近更新: 2018年1月29日

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).
•oDermatomyositis
•oNon-specific myositis/antisynthetase syndrome
•oImmune-mediated necrotizing myopathy
•Minimal disability of:
•oMMT score reduction of 10% or lower and,
•o2 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
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•IVIg treatment related:
•oSubjects who have received systemic immunosuppressive/immunomodulatory medication within the last 6 months with the execption of prednisone dosed as follows:
•?daily dose of 20mg or lower
•?used for 2 weeks or less
•?no evident clinical response
•ohistory of thrombotic episodes within the 2 years prior to enrolment
•oknown allergic reactions or other severe reactions to any blood-derived product
•oknown IgA deficiency and anti-IgA serum antibodies
•opregnancy (wish).
•Conditions that are likely to interfere with:
•ocompliance (legal incompetent and/or incapacitated patients are excluded) or,
•oevaluation 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

Academic Medical Center