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

NCT07374107 | Recruiting

• 2 other identifiers: MIHRA - 001PRISMS
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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. 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/

Conditions

IBM; IIM; Myositis; Inflammatory Myopathy; Dermatomyositis; Dermatomyositis, Juvenile; Anti-synthetase Syndrome; Immune-Mediated Necrotizing Myopathy; Polymyositis; Inclusion Body Myositis; Juvenile Myositis; Juvenile Dermatomyositis

Keywords

myositis; rare diseases; patient priorities; patient engagement; patient initiated; patient research partners; qualitative research; mixed methods research; research priorities

Outcome Measures

Primary Outcomes (1)

• 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.

  At completion of narrative, focus group forum or survey, up to 90 minute

Study Arms (1)

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

Interventions

No intervention - qualitative and mixed methods investigations OTHER

No Intervention

Individuals living with a myositis disease

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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/

You may not qualify if:

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

Sponsors & Collaborators

• Myositis International Health & Research Collaborative Alliance Foundation: lead
• Myositis Australia: collaborator
• CureJM: collaborator
• The Myositis Association: collaborator
• The Dutch Myositis Association: collaborator
• The Swedish Myositis Association: collaborator
• Myositis UK: collaborator
• The German Myositis Association: collaborator
• CARRA - Childhood Arthritis & Rheumatology Research Alliance: collaborator
• PReS - Paediatric Rheumatology European Society: collaborator
• MIHRA Patient Advisory: collaborator

Study Sites (1)

MIHRA Foundation - This is a GLOBAL STUDY

New Orleans, Louisiana, 70130, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 38436382 BACKGROUND

• Lanis 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.

  PMID: 38488093 BACKGROUND

• Saketkoo 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.

  PMID: 37449887 BACKGROUND

Related Links

• How to Participate through the MIHRA Patient Contact Registry

MeSH Terms

Conditions

Myositis; Dermatomyositis; Polymyositis; Myositis, Inclusion Body; Rare Diseases; Patient Participation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lesley Ann Saketkoo, MD, MPH

  MIHRA Foundation

  STUDY CHAIR

Central Study Contacts

Lesley Ann Saketkoo, MD/MPH

CONTACT

504 822 6653; info@MiHRAfoundation.org

Barbara Shafranski

CONTACT

504 822 6653; info@MIHRAfoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Data will become available immediately and remain available
• Access Criteria: Through publication and by contacting info@MIHRAfoundation.org

Locations

US (1)