NCT05046821

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Oct 2021Mar 2027

First Submitted

Initial submission to the registry

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

September 8, 2021

Last Update Submit

February 13, 2026

Conditions

Inclusion Body MyositisSporadic Inclusion Body Myositis

Outcome Measures

Primary Outcomes (4)

  • Inclusion Body Myositis Functional Rating Scale (IBMFRS)

    The IBMFRS is a 10 item questionnaire. Scores for each item range from 0 to 4. There is a total maximum score of 40 and minimum score of 0. The higher the score the better functional status of the person.

    Change from Baseline to Month 24

  • Timed Up and Go (TUG)

    Stand up from a chair, walk 3 meters, sit back down in chair

    Change from Baseline to Month 24

  • Frequency of immunophenotypic abnormalities in blood and muscle

    Laboratory assessment

    Change from Baseline to Month 24

  • Forced Vital Capacity (FVC) (sitting)

    breathing test

    Change from Baseline to Month 24

Secondary Outcomes (8)

  • Manual Muscle Testing

    Change from Baseline to Month 24

  • Hand Held Dynamometry

    Change from Baseline to Month 24

  • Sydney Swallow Questionnaire

    Change from Baseline to Month 24

  • EAT-10 Questionnaire

    Change from Baseline to Month 24

  • NIH PROMIS questionnaires

    Change from Baseline to Month 24

  • +3 more secondary outcomes

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Paticipants age 40 and older with sporadic IBM, diagnosed according to established criteria.

You may qualify if:

  • Ages 40 years and older
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Kansas University Medical Center

Fairway, Kansas, 66205, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Nerve and Muscle Center of Texas

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA will be isolated from blood and muscle samples and stored for future research

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Tahseen Mozaffar, MD FAAN, FANA

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

October 11, 2021

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

US(13)