Sporadic Inclusion Body MyositisINSPIRE-IBMNCT05046821
Sporadic Inclusion Body Myositis Natural History Study
An observational study of Sporadic Inclusion Body Myositis and Inclusion Body Myositis, run by University of California, Irvine at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sporadic Inclusion Body Myositis, Inclusion Body Myositis
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Oct 2021to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Paticipants age 40 and older with sporadic IBM, diagnosed according to established criteria.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ohio State University
Columbus, Ohio, 43221
Kansas University Medical Center
Fairway, Kansas, 66205
Nerve and Muscle Center of Texas
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
University of California, Irvine
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
University of Washington
Seattle, Washington, 98195
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Influence of NT5c1A Antibodies on Disease Progression, Clinical Phenotype and Blood and Muscle Biomarkers in Sporadic Inclusion Body Myositis - A Prospective Evaluation (INSPIRE-IBM Study)
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.
Read the detailed description
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 with sporadic IBM, diagnosed according to established criteria. Participants will require an routine serum sample via blood draw to evaluate for NT5c1A antibody status. This testing will be performed at Washington University School of Medicine in the Neuromuscular Laboratory. Investigators will be blinded to antibody status. A subset of participants (40) will undergo a muscle biopsy at the Baseline visit.
Aim 1. To determine for the first time whether NT5c1A antibodies mediate disease progression over a two-year interval in patients with sIBM.
We will perform a prospective, non-interventional, observational study on patients with sIBM with follow up and evaluations every 6 months over a two-year time frame. Primary analyses are: 1) the rates of disease progression and severity as measured by rates of decline in IBM Functional Rating Scale (IBMFRS) score and Timed Get Up and Go (TUG); 2) the presence or absence of serum antibodies to NT5c1A; and 3) the presence and frequency of variant T-cells in the serum and skeletal muscle.
Aim 2. To perform a detailed morphological, histochemical and immunohistochemical analysis of fresh muscle biopsy specimens obtained from a subset of patients with sIBM.
Aim 3. To characterize the distribution of "immunosenescent" lymphocytes in circulating blood from patients with sIBM.
Aim 4. To quantify the decline in the respiratory function of sIBM patients.
- Medical subject headings
- Myositis, Inclusion Body
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Month 24
Timed Up and Go (TUG)
Stand up from a chair, walk 3 meters, sit back down in chair
Measured: Change from Baseline to Month 24
Frequency of immunophenotypic abnormalities in blood and muscle
Laboratory assessment
Measured: Change from Baseline to Month 24
Forced Vital Capacity (FVC) (sitting)
breathing test
Measured: Change from Baseline to Month 24
Secondary outcomes (8)
Manual Muscle Testing
muscle strength testing
Measured: Change from Baseline to Month 24
Hand Held Dynamometry
muscle strength testing
Measured: Change from Baseline to Month 24
Sydney Swallow Questionnaire
swallow ability questionnaire
Measured: Change from Baseline to Month 24
EAT-10 Questionnaire
swallow ability questionnaire
Measured: Change from Baseline to Month 24
NIH PROMIS questionnaires
quality of life questionnaires
Measured: Change from Baseline to Month 24
Forced Vital Capacity (supine)
breathing test done while lying down
Measured: Change from Baseline to Month 24
Maximum Inspiratory Pressure/Maximum Expiratory Pressure
breathing tests
Measured: Change from Baseline to Month 24
sporadic inclusion body myositis physical functioning assessment (sIFA)
functional ability questionnaire
Measured: Change from Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start11 Oct 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sporadic Inclusion Body MyositisStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Tahseen Mozaffar, University of California, Irvine
- Investigators
- Tahseen Mozaffar, MD FAAN, FANA, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046821
- Sponsor's protocol ID
- 20216779
- Other IDs
- R01AR078340-01
- Acronym
- INSPIRE-IBM
- Status last verified
- May 2026
- First submitted
- 8 Sep 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of NT5c1A Antibodies on Disease Progression, Clinical Phenotype and Blood and Muscle Biomarkers in Sporadic Inclusion Body Myositis - A Prospective Evaluation (INSPIRE-IBM Study)
- ClinicalTrials.gov ID
- NCT05046821
- Acronym / sponsor ID
- INSPIRE-IBM / 20216779
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 with sporadic IBM, diagnosed according to established criteria. Participants will require an routine serum sample via blood draw to evaluate for NT5c1A antibody status. This testing will be performed at Washington University School of Medicine in the Neuromuscular Laboratory. Investigators will be blinded to antibody status. A subset of participants (40) will undergo a muscle biopsy at the Baseline visit.
Aim 1. To determine for the first time whether NT5c1A antibodies mediate disease progression over a two-year interval in patients with sIBM.
We will perform a prospective, non-interventional, observational study on patients with sIBM with follow up and evaluations every 6 months over a two-year time frame. Primary analyses are: 1) the rates of disease progression and severity as measured by rates of decline in IBM Functional Rating Scale (IBMFRS) score and Timed Get Up and Go (TUG); 2) the presence or absence of serum antibodies to NT5c1A; and 3) the presence and frequency of variant T-cells in the serum and skeletal muscle.
Aim 2. To perform a detailed morphological, histochemical and immunohistochemical analysis of fresh muscle biopsy specimens obtained from a subset of patients with sIBM.
Aim 3. To characterize the distribution of "immunosenescent" lymphocytes in circulating blood from patients with sIBM.
Aim 4. To quantify the decline in the respiratory function of sIBM patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paticipants age 40 and older with sporadic IBM, diagnosed according to established criteria.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inclusion Body Myositis Functional Rating Scale (IBMFRS)
Time frame: Change from Baseline to Month 24
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.
Timed Up and Go (TUG)
Time frame: Change from Baseline to Month 24
Stand up from a chair, walk 3 meters, sit back down in chair
Frequency of immunophenotypic abnormalities in blood and muscle
Time frame: Change from Baseline to Month 24
Laboratory assessment
Forced Vital Capacity (FVC) (sitting)
Time frame: Change from Baseline to Month 24
breathing test
8 secondary outcomes
Manual Muscle Testing
Time frame: Change from Baseline to Month 24
Hand Held Dynamometry
Time frame: Change from Baseline to Month 24
Sydney Swallow Questionnaire
Time frame: Change from Baseline to Month 24
EAT-10 Questionnaire
Time frame: Change from Baseline to Month 24
NIH PROMIS questionnaires
Time frame: Change from Baseline to Month 24
Forced Vital Capacity (supine)
Time frame: Change from Baseline to Month 24
Maximum Inspiratory Pressure/Maximum Expiratory Pressure
Time frame: Change from Baseline to Month 24
sporadic inclusion body myositis physical functioning assessment (sIFA)
Time frame: Change from Baseline to Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tahseen Mozaffar, MD FAAN, FANA principal investigator
University of California, Irvine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sporadic Inclusion Body Myositis and Inclusion Body Myositis, run by University of California, Irvine at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion Body Myositis Functional Rating Scale (IBMFRS) (time frame: Change from Baseline to Month 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.