Active — Not RecruitingNot Applicable

Sporadic Inclusion Body Myositis Natural History Study

United States150 participantsStarted 2021-10-11

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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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.

What they're measuring

Inclusion Body Myositis Functional Rating Scale (IBMFRS)

Timeframe: Change from Baseline to Month 24

Timed Up and Go (TUG)

Timeframe: Change from Baseline to Month 24

Frequency of immunophenotypic abnormalities in blood and muscle

Timeframe: Change from Baseline to Month 24

Forced Vital Capacity (FVC) (sitting)

Timeframe: Change from Baseline to Month 24

Trial details

NCT IDNCT05046821

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Sporadic Inclusion Body Myositis trials