We Need Your Help

Are you frustrated that medical science knows so little about inclusion body myositis?

Do you wish that more pharmaceutical companies would fund clinical drug trials for IBM?

You can help!

The INSPIRE-IBM natural history study needs patients. If you qualify and live near a study site in the United States, please volunteer. If you don’t qualify, spread the word to other people with IBM. Call a friend, post on social media, and make sure that everyone you know who has IBM is aware of this study.

What is the INSPIRE-IBM Study and Why is it Important?

First of all, it is a natural history study, which means that it gathers information about patients and observes how the patients change as time passes. The purpose of the study is to learn more about IBM, how it affects the body, how it progresses, and how the progression can be measured. Participants will not be receiving any new treatments for IBM, but that doesn’t mean that the study is less valuable than a clinical drug trial. Natural history studies are extremely important for rare diseases.

The INSPIRE-IBM study is designed to answer crucial questions, such as:

How quickly does IBM progress? Can people with slow or fast progression be predicted based on their characteristics at the beginning of the study?

Which physical tests are the most sensitive and reliable for detecting changes in muscle strength and function?

Do people who test positive for the anti-cN1A (NT5c1A) antibody have different characteristics than those who have a negative test? Is their progression faster?

Can the study identify IBM biomarkers, tests that could be used to reliably measure the progression of inclusion body myositis?

Answering these questions will not only increase our general knowledge about IBM, but will also help drug companies who might sponsor a future clinical drug trial for IBM.

Tell Me More About The Study

The INSPIRE-IBM study is planned for a total of 150 participants at major medical centers across the United States. Participants will have an initial evaluation and then will be seen every six months for two years, so there will be five total visits.

The evaluations will include questionnaires, physical tests of muscle function and strength, blood tests, and breathing tests. Blood will be tested for the NT5c1A antibody, and will also be extensively analyzed for various immune system proteins and types of white blood cells. RNA and DNA will be collected for future analysis. The breathing tests are important because previous studies have largely neglected this aspect of the disease, so the INSPIRE-IBM study may uncover important information.

The study hopes to obtain a muscle biopsy from 40 people. Biopsies are taken from the biceps muscle in the upper arm. The muscle biopsy is completely optional — whether or not you agree to a biopsy does not affect your ability to enroll. However, if you are willing to have a biopsy, your participation would be extremely valuable.

Who Is Eligible?

People with an established diagnosis of inclusion body myositis who first developed significant symptoms of the disease within the past 10 years are eligible.

However, if you received an investigational medication or therapy within 90 days of the initial visit, or immunosuppressive medication within 6 months, you are not eligible.

It is important to note that, unlike most clinical drug trials, you are eligible to participate even if you are unable to perform all of the physical tests. For example, if you cannot stand up from a chair or walk, you can still enroll in the study.

Where are More Participants Needed?

The following locations are accepting new participants:

University of California, Irvine, CA
Marie Wencel: mwencel@hs.uci.edu

University of California, Los Angeles, CA
Denisse Velazquez: DenisseVelazquez@mednet.ucla.edu

Oregon Health and Science University, Portland, OR
Sonya Boyd: boydso@ohsu.edu

University of Washington, Seattle, WA
Mike Willis: mwillis5@uw.edu

University of Colorado, Denver, CO
Karen Parada: karen.parada@cuanschutz.edu

Kansas University Medical Center, Kansas City, KS
Lillian Saavedra: lsaavedra2@kumc.edu

Brigham and Women’s Hospital, Boston, MA
Mary Kate Gannon: mgannon2@partners.org

How Many Participants Are Still Needed?

The goal is to enroll 150 people. At this time 123 people are enrolled, so we need 27 more. We can do this! Help us meet the goal! Your participation will help the entire IBM community. A successful study will increase our knowledge about IBM and pave the way for future clinical drug trials.

More Information

For more information about the Inspire-IBM study, visit clinicaltrials.gov.

More information about natural history studies and clinical trials

Kevin Dooley, MD

August 8, 2023

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