The natural history of inclusion body myositis

Not Applicable

Completed

• Conditions: Inclusion body myositis; Nervous System Diseases; Inflammatory myopathy, not elsewhere classified

• Registration Number: ISRCTN96803614
• Lead Sponsor: niversity College London Hospitals NHS Foundation Trust (UK)

Brief Summary

2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/23489664 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-21
• Study Completion: 2022-04-01
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified