MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) (MIHRA-PRISMS)

January 20, 2026 updated by: Myositis International Health & Research Collaborative Alliance Foundation

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/

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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/

Exclusion Criteria:

  • Under the age of 7 years old
  • Do not have a diagnosis of an inflammatory myopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No intervention - qualitative and mixed methods investigations
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At completion of narrative, focus group forum or survey, up to 90 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myositis International Health & Research Collaborative Alliance Foundation

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

Investigators

  • Study Chair: Lesley Ann Saketkoo, MD, MPH, MIHRA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIHRA - 001
  • PRISMS (Other Identifier: MIHRA Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified aggregate themes/coded domains may be shared; raw transcripts/audio will not be shared.

IPD Sharing Time Frame

Data will become available immediately and remain available

IPD Sharing Access Criteria

Through publication and by contacting info@MIHRAfoundation.org

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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