[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07374107":3,"trial-entities:NCT07374107":117,"trial-summary:NCT07374107":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":31,"study_type":41,"primary_purpose":42,"phases":43,"enrollment_info":44,"interventions":47,"primary_outcomes":53,"secondary_outcomes":58,"sex":59,"minimum_age":60,"maximum_age":42,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":70,"locations":74,"central_contacts":93,"overall_officials":98,"references":102,"see_also_links":113},"NCT07374107","MIHRA - 001","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases","RECRUITING","2030-12","2026-01","2026-01-28","2025-06-25","Myositis International Health & Research Collaborative Alliance Foundation","OTHER",false,"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.\n\nPotential participants can express interest via https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F","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\u002Fclinical characteristics.\n\nMethods include open-ended narratives, interactive focus groups and forums, rating and ranking to establish degree of importance and priorities.\n\nResults will include a structured set of patient-voiced priority topics\u002Fquestions and a draft framework for downstream consensus processes and research agenda setting.",[19,20,21,22,23,24,25,26,27,28,29,30],"IBM","IIM","Myositis","Inflammatory Myopathy","Dermatomyositis","Dermatomyositis, Juvenile","Anti-synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Polymyositis","Inclusion Body Myositis","Juvenile Myositis","Juvenile Dermatomyositis",[32,33,34,35,36,37,38,39,40],"myositis","rare diseases","patient priorities","patient engagement","patient initiated","patient research partners","qualitative research","mixed methods research","research priorities","OBSERVATIONAL",null,[],{"count":45,"type":46},700,"ESTIMATED",[48],{"type":14,"name":49,"description":50,"armGroupLabels":51},"No intervention - qualitative and mixed methods investigations","No Intervention",[52],"Individuals living with a myositis disease",[54],{"measure":55,"description":56,"timeFrame":57},"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",[],"ALL","7 Years",{"inclusion":62,"exclusion":66,"raw_text":69},[63,64,65],"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:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F",[67,68],"Under the age of 7 years old","Do not have a diagnosis of an inflammatory myopathy","Inclusion Criteria:\n\n* Ability to provide informed consent\n* 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.\n* Participants who may have signed up through the MIHRA Patient Contact Registry https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F\n\nExclusion Criteria:\n\n* Under the age of 7 years old\n* Do not have a diagnosis of an inflammatory myopathy",[71,72,73],"CHILD","ADULT","OLDER_ADULT",[75],{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":90},"MIHRA Foundation - This is a GLOBAL STUDY","New Orleans","Louisiana","70130","United States",[82,87],{"name":83,"role":84,"phone":85,"email":86},"Lesley Ann Saketkoo, MD, MPH","CONTACT","504-822-6653","info@MIHRAfoundation.org",{"name":88,"role":84,"phone":89,"email":86},"Barbara Shafranski","504 822 6653",{"lat":91,"lon":92},29.95465,-90.07507,[94,97],{"name":95,"role":84,"phone":89,"email":96},"Lesley Ann Saketkoo, MD\u002FMPH","info@MiHRAfoundation.org",{"name":88,"role":84,"phone":89,"email":86},[99],{"name":83,"affiliation":100,"role":101},"MIHRA Foundation","STUDY_CHAIR",[103,107,110],{"pmid":104,"type":105,"citation":106},"38436382","BACKGROUND","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\u002Fclinexprheumatol\u002Fhc1lsf. Epub 2024 Mar 4.",{"pmid":108,"type":105,"citation":109},"38488093","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\u002Fclinexprheumatol\u002Fcngdfn. Epub 2024 Mar 14.",{"pmid":111,"type":105,"citation":112},"37449887","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\u002FMIHRA) 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\u002Frheumatology\u002Fkead331. No abstract available.",[114],{"label":115,"url":116},"How to Participate through the MIHRA Patient Contact Registry","https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F",{"nct_id":4,"conditions":118,"biomarkers":122},[119,120,23,121,26,28,27],"Anti-Synthetase Syndrome","Childhood Dermatomyositis","Idiopathic Inflammatory Myopathy",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":135},true,{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is an observational study that will gather information from about 700 participants. It uses qualitative and mixed methods, mostly online, to understand patient perspectives.","completed","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) Study","This study, called PRISMS, wants to understand what research topics are most important to people living with myositis diseases like IBM, IIM, Myositis, Inflammatory Myopathy, and Dermatomyositis. Since these are rare diseases, this study aims to gather your perspectives, or those of your care partner, through online open-ended questions, community forums, and surveys. There are no interventions or drugs being tested. The goal is to create a list of research priorities directly from patients to help guide future research and funding decisions. The study is currently unclear on its recruitment status and plans to include about 700 participants.","Your input will be measured at the completion of your narrative, focus group forum, or survey, up to 90 minutes.",98,"You would participate in methods like open-ended narratives, interactive focus groups, forums, and rating\u002Franking activities. Each activity could last up to 90 minutes.","Not stated in the trial record.",[],"v2"]