The natural history of inclusion body myositis: an observational cohort study

niversity College London Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 120 人开始时间: 2013年2月21日最近更新: 2022年4月25日

适应症

试验速览

•Any person who meets the established diagnostic criteria for inclusion body myositis. The age criteria set above in section A16 are to allow for one criterion being age at onset of over 30, while the upper limit is set so as not to exclude any participant on the grounds of being too old.
•Griggs' diagnostic criteria for IBM:
•Clinical features:
•1. Illness duration of more than six months
•2. Male and female, age at onset greater than 30 years
•3. Proximal and distal weakness of arms and legs, with finger flexion weakness, wrist flexion more than extension weakness, and quadriceps weakness.
•Laboratory features:
•1. Creatine kinase (CK) less than 12 times normal
•2. Neurophysiology consistent with myopathy
•Muscle biopsy features:
•1. Inflammation with mononuclear cell invasion of non-necrotic fibres
•2. Vacuolated fibres
•3. Intracellular amyloid and/or 15?18 nm filaments on electron microscopy
•If all the muscle biopsy features above are present, then the disease is labelled as definite (regardless of the presence or absence of other criteria). To meet the probable standard of disease, then the muscle biopsy must show at least inflammation and vacuolation of fibres, plus all the clinical and laboratory features above.

发起方

niversity College London Hospitals NHS Foundation Trust (UK)