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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.

Join this Trial

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Study Stats
Protocol No.
21-001077
Category
Neurology
Urology
Contact
Denisse Velazquez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05046821
For detailed technical eligibility, visit ClinicalTrials.gov.