Sporadic Inclusion Body Myositis Natural History Study

Running, not enrolling

Conditions studied: Sporadic Inclusion Body Myositis, Inclusion Body Myositis

In brief

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.

Key facts

Study ID

NCT05046821

Run by

University of California, Irvine

People needed

150

Starts

2021-10-11

Expected to finish

2027-03-31

Last updated by the study team

2026-05-27

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of California, Irvine — Orange, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Miami — Miami, Florida, United States
• Kansas University Medical Center — Fairway, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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