Sporadic Inclusion Body Myositis Natural History Study (NCT05046821) | Clinical Trial Compass
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 range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inclusion Body Myositis Functional Rating Scale (IBMFRS)
Timeframe: Change from Baseline to Month 24
2
Timed Up and Go (TUG)
Timeframe: Change from Baseline to Month 24
3
Frequency of immunophenotypic abnormalities in blood and muscle
. 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.