Investigating genes in patients with polymyositis and dermatomyositis

Not Applicable

• Conditions: Polymyositis, dermatomyositis and inclusion body myositis; Musculoskeletal Diseases

• Registration Number: ISRCTN28639298
• Lead Sponsor: Manchester University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-21
• Last Update Posted: 16 February 2021
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1947

Inclusion Criteria

1. Skin lesions of (DM):
1.1. Heliotrope rash (violaceous rash and on upper eyelids)
1.2. Gottron?s sign (violaceous keratotic macules on extensor aspect of finger joints)
1.3. Violaceous slightly raised rash over elbows/knees
2. Proximal muscle weakness (PM, DM and IBM)
3. Elevated plasma muscle enzymes
4. Myalgia, at rest or with contraction
5. Myopathic changes on electromyogram (EMG)
6. Anti Jo1 Ab
7. Nondestructive arthritis
8. Systemic inflammatory signs (fever, erythrocyte sedimentation rate [ESR] greater than 20, elevated C-reactive protein [CRP], weight loss)
9. Myositic changes on muscle biopsy
10. Additional patients with proven Inclusion Body Myositis (IBM)
11. Male and female, lower age limit of 18 years

Exclusion Criteria

1. Below the age of 18 years
2. Myositis secondary to:
2.1. Alcohol or drug abuse
2.2. Non-abusive drug ingestion (e.g with statins, fibrates etc), or
2.3. A recent viral illnesses
3. Unable to give consent due to diminished mental capacity or inability to speak sufficient English
4. Unwilling to give blood samples

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify any disease susceptibility genes associated with development and clinical characteristics, measured once conformation GWAS performed (possibly 2020)

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures