Sporadic Inclusion Body Myositis Natural History Study

About

Brief Summary

This is a prospective natural history study on patients with clinically defined sIBM. Participants will be assessed every 6 months over two years (five visits total). We will include 150 participants, enrolled across 13 sites, with sporadic IBM, diagnosed according to established criteria.

Study Type

Observational

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

N/A

Inclusion Criteria:

Ages 40 years and older
Fulfills ENMC 2011 criteria of clinically definite or probable sporadic Inclusion body myositis (sIBM)
Disease onset is within the past 10 years of the time of Baseline visit
Able to participate and comply with study related procedures
Able to provide written consent

Exclusion Criteria:

Current or very recent use (within last 6 months of the Baseline visit) of immunomodulation or immunosuppression therapy.
Current or very recent use (within last 90 days of the Baseline visit) of an investigational medication or therapy.
Co-existing significant medical or surgical conditions that, in the opinion of the investigator, will influence study participation or alter natural history.

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