IBMMIHRA-PRISMSNCT07374107
MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)
An observational study of IBM and IIM, run by Myositis International Health & Research Collaborative Alliance Foundation at 1 site in United States.
Trial summary
Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. Read more about this study
- Who is it for?
- Ages 7 years and older
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to Dec 2030
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children living with an idiopathic inflammatory myopathy recruited through self-referral (prompted by clinic notices/ patient organization newsletters / /advocacy communities / social media / internet searches ) to provide perspectives on research priorities.
Who may be able to join
- Ability to provide informed consent
- Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.
- Participants who may have signed up through the MIHRA Patient Contact Registry https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/
Who cannot join
- Under the age of 7 years old
- Do not have a diagnosis of an inflammatory myopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MIHRA Foundation - This is a GLOBAL STUDY
New Orleans, Louisiana, 70130
Lesley Ann Saketkoo, MD, MPH, 504-822-6653, info@MIHRAfoundation.org
Barbara Shafranski, 504 822 6653, info@MIHRAfoundation.org
About this study
Official title: MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases
Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases.
Potential participants can express interest via https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/
Read the detailed description
This is a patient-initiated observational qualitative (largely online) study engaging people living with myositis diseases (and optionally their care partners) in mixed methods applications to elicit patient-voiced research priorities. Participants will be purposively sampled to ensure representation across myositis subtypes and key demographic/clinical characteristics.
Methods include open-ended narratives, interactive focus groups and forums, rating and ranking to establish degree of importance and priorities.
Results will include a structured set of patient-voiced priority topics/questions and a draft framework for downstream consensus processes and research agenda setting.
- Conditions
- IBM, IIM, Myositis, Inflammatory Myopathy, Dermatomyositis, Dermatomyositis, Juvenile
- Being tested
- No intervention - qualitative and mixed methods investigations
- Keywords
- myositis, rare diseases, patient priorities, patient engagement, patient initiated, patient research partners, qualitative research, mixed methods research, research priorities
- Medical subject headings
- Myositis, Dermatomyositis, Polymyositis, Myositis, Inclusion Body, Rare Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - qualitative and mixed methods investigationsOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Individuals living with a myositis disease | Adults and children with a clinician diagnosis of an inflammatory myopathy (and optionally caregivers/partners) will express their priorities and insights regarding regarding research priorities across myositis diseases. Receives: Other: No intervention - qualitative and mixed methods investigations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-voiced research priority topics
Number and distribution of coded priority domains identified from data collection that has been stratified by disease type, through thematic analysis (codebook refined iteratively) with subsequent assigned degree of importance and ranked priority.
Measured: At completion of narrative, focus group forum or survey, up to 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start25 Jun 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBMStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myositis International Health & Research Collaborative Alliance Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- MIHRA Patient Advisory, Myositis Australia, CureJM, The Myositis Association, The Dutch Myositis Association, The Swedish Myositis Association, Myositis UK, The German Myositis Association, CARRA - Childhood Arthritis & Rheumatology Research Alliance, PReS - Paediatric Rheumatology European Society
- Responsible party
- Sponsor
- Investigators
- Lesley Ann Saketkoo, MD, MPH, Study chair, MIHRA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374107
- Sponsor's protocol ID
- MIHRA - 001
- Other IDs
- PRISMS
- Acronym
- MIHRA-PRISMS
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified aggregate themes/coded domains may be shared; raw transcripts/audio will not be shared.
Publications
Saketkoo LA, Paik JJ, Alexanderson H, Dimachkie MM, Ernste FC, Naddaf E, Shafranski B, Gupta L, Mecoli CA, Saygin D, Albayda J, Basharat P, Day JA, Valenzuela A, Bromley R, de Groot I, Edison SE, Lanis A, Lood C, Regardt M, Yi BY, Benitez AC, Chinoy H, Christopher-Stine L, Isenberg DA, Lang B, Oddis CV, van Royen A, Vencovsky J, Werth VP, Machado PM. Collaborative research in myositis-related disorders: MIHRA, a global shared community model. Clin Exp Rheumatol. 2024 Feb;42(2):207-212. doi: 10.55563/clinexprheumatol/hc1lsf. Epub 2024 Mar 4.
PubMed 38436382Lanis A, Alexanderson H, Ardalan K, Edison S, Graham CD, de Groot I, Gupta L, Kim S, Knight AM, Kobert L, Livermore P, Lood C, Pilkington C, Regardt M, Rubinstein TB, Shenoi S, Turnier L, Voet NBM, Wahezi DM, Saketkoo LA. Mental health in paediatric and adult myositis-related diseases: current state of research, interventions, and future steps from the MIHRA Psychological Impact Scientific Working Group. Clin Exp Rheumatol. 2024 Feb;42(2):413-424. doi: 10.55563/clinexprheumatol/cngdfn. Epub 2024 Mar 14.
PubMed 38488093Saketkoo LA, Valenzuela A, Kim S, McCann LJ, Lood C, Wahezi DM, Werth VP, Yi B, Alexanderson H, Maillard S, Pilkington C, Fligelstone K, Limbach B, Orandi AB, Regardt M, Russell AM, Davuluri S, deGroot I, Ernste F, Paik JJ, von Muhlen CA, Dimachkie MM, Machado PM, Naddaf E, Shafranski BM, Gupta L, Zulian F, Chung L; International Myositis Assessment and Clinical Studies Group and The Myositis International Research and Health Collaborative Alliance (IMACS/MIHRA) Calcinosis Scientific Interest Group. Moving forward together: collaborative landscapes of research in idiopathic inflammatory myopathies and calcinosis. Rheumatology (Oxford). 2024 May 2;63(5):1189-1191. doi: 10.1093/rheumatology/kead331. No abstract available.
PubMed 37449887
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases
- ClinicalTrials.gov ID
- NCT07374107
- Acronym / sponsor ID
- MIHRA-PRISMS / MIHRA - 001
- Conditions
- IBM, IIM, Myositis, Inflammatory Myopathy, Dermatomyositis, Dermatomyositis, Juvenile
- Keywords
- myositis, rare diseases, patient priorities, patient engagement, patient initiated, patient research partners, qualitative research, mixed methods research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Myositis International Health & Research Collaborative Alliance FoundationUniversity, hospital or other
- Collaborators
- MIHRA Patient Advisory, Myositis Australia, CureJM, The Myositis Association, The Dutch Myositis Association, The Swedish Myositis Association, Myositis UK, The German Myositis Association, CARRA - Childhood Arthritis & Rheumatology Research Alliance, PReS - Paediatric Rheumatology European Society
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Jan 2026 (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.
Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases.
Potential participants can express interest via https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/
Detailed description
This is a patient-initiated observational qualitative (largely online) study engaging people living with myositis diseases (and optionally their care partners) in mixed methods applications to elicit patient-voiced research priorities. Participants will be purposively sampled to ensure representation across myositis subtypes and key demographic/clinical characteristics.
Methods include open-ended narratives, interactive focus groups and forums, rating and ranking to establish degree of importance and priorities.
Results will include a structured set of patient-voiced priority topics/questions and a draft framework for downstream consensus processes and research agenda setting.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals living with a myositis disease | – | Other: No intervention - qualitative and mixed methods investigationsAdults and children with a clinician diagnosis of an inflammatory myopathy (and optionally caregivers/partners) will express their priorities and insights regarding regarding research priorities across myositis diseases. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children living with an idiopathic inflammatory myopathy recruited through self-referral (prompted by clinic notices/ patient organization newsletters / /advocacy communities / social media / internet searches ) to provide perspectives on research priorities.
Key inclusion criteria (3 listed)
- Ability to provide informed consent
- Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.
- Participants who may have signed up through the MIHRA Patient Contact Registry https://mihrafoundation.org/mihra-programs/mihra-patient-contact-registry/
Key exclusion criteria (2 listed)
- Under the age of 7 years old
- Do not have a diagnosis of an inflammatory myopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - qualitative and mixed methods investigationsNo Intervention | Other | Individuals living with a myositis disease |
Primary outcome
Patient-voiced research priority topics
Time frame: At completion of narrative, focus group forum or survey, up to 90 minute
Number and distribution of coded priority domains identified from data collection that has been stratified by disease type, through thematic analysis (codebook refined iteratively) with subsequent assigned degree of importance and ranked priority.
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 28 Jan 2026.
- Background: PubMed 38436382Saketkoo LA, Paik JJ, Alexanderson H, Dimachkie MM, Ernste FC, Naddaf E, Shafranski B, Gupta L, Mecoli CA, Saygin D, Albayda J, Basharat P, Day JA, Valenzuela A, Bromley R, de Groot I, Edison SE, Lanis A, Lood C, Regardt M, Yi BY, Benitez AC, Chinoy H, Christopher-Stine L, Isenberg DA, Lang B, Oddis CV, van Royen A, Vencovsky J, Werth VP, Machado PM. Collaborative research in myositis-related disorders: MIHRA, a global shared community model. Clin Exp Rheumatol. 2024 Feb;42(2):207-212. doi: 10.55563/clinexprheumatol/hc1lsf. Epub 2024 Mar 4.
- Background: PubMed 38488093Lanis A, Alexanderson H, Ardalan K, Edison S, Graham CD, de Groot I, Gupta L, Kim S, Knight AM, Kobert L, Livermore P, Lood C, Pilkington C, Regardt M, Rubinstein TB, Shenoi S, Turnier L, Voet NBM, Wahezi DM, Saketkoo LA. Mental health in paediatric and adult myositis-related diseases: current state of research, interventions, and future steps from the MIHRA Psychological Impact Scientific Working Group. Clin Exp Rheumatol. 2024 Feb;42(2):413-424. doi: 10.55563/clinexprheumatol/cngdfn. Epub 2024 Mar 14.
- Background: PubMed 37449887Saketkoo LA, Valenzuela A, Kim S, McCann LJ, Lood C, Wahezi DM, Werth VP, Yi B, Alexanderson H, Maillard S, Pilkington C, Fligelstone K, Limbach B, Orandi AB, Regardt M, Russell AM, Davuluri S, deGroot I, Ernste F, Paik JJ, von Muhlen CA, Dimachkie MM, Machado PM, Naddaf E, Shafranski BM, Gupta L, Zulian F, Chung L; International Myositis Assessment and Clinical Studies Group and The Myositis International Research and Health Collaborative Alliance (IMACS/MIHRA) Calcinosis Scientific Interest Group. Moving forward together: collaborative landscapes of research in idiopathic inflammatory myopathies and calcinosis. Rheumatology (Oxford). 2024 May 2;63(5):1189-1191. doi: 10.1093/rheumatology/kead331. No abstract available.
- How to Participate through the MIHRA Patient Contact RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified aggregate themes/coded domains may be shared; raw transcripts/audio will not be shared.
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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.
Lesley Ann Saketkoo, MD, MPH study chair
MIHRA Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBM and IIM, run by Myositis International Health & Research Collaborative Alliance Foundation at 1 site 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Lesley Ann Saketkoo, MD/MPH (504 822 6653, info@MiHRAfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-voiced research priority topics (time frame: At completion of narrative, focus group forum or survey, up to 90 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374107, which also lists 3 linked publications.
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 28 Jan 2026.