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The Myositis Clinical Trials Consortium: an international collaborative initiative to promote clinical trials in adult and juvenile myositis

A. Bishnoi, IYK. Tang, A. Yoshida, FM. Pais, SY. Usman, SA. Dominguez, CG. Kavadichanda, D. Rivero-Gallegos, E. Dourado, E. Conticini, F. Bozán, G. Tulluru, JB. Lilleker, K. Sreerama Reddy, O. Landon-Cardinal, R. Smaili, S. Keret, T. Khoo, TY....

. 2025 ; 43 (2) : 202-210. [pub] 20250220

Language English Country Italy

Document type Journal Article, Review

Idiopathic inflammatory myopathies (IIM), or myositis, are a heterogeneous group of systemic autoimmune disorders that are associated with significant morbidity and mortality. Conducting high-quality clinical trials in IIM is challenging due to the rare and variable presentations of disease. To address this challenge, the Myositis Clinical Trials Consortium (MCTC) was formed. MCTC is a collaborative international alliance dedicated to facilitating, promoting, coordinating and conducting clinical trials and related research in IIM. This partnership works to advance the discovery of effective evidence-based treatments for IIM by integrating a diverse group of clinical investigators, research professionals, medical centres, patient groups, and industry partners. The Steering Committee, Core Group, and Paediatric Subcommittee of MCTC are comprised of myositis experts and junior investigators from around the world, representing a diversity of genders, geographies, and subspecialties. MCTC works alongside other current myositis organisations to complement existing work by concentrating on the operationalisation of clinical trials. Our pilot Myositis Investigators' Information Survey gathered responses from 173 myositis investigators globally and found considerable variability in proficiency with outcome measures, geographic disparities in patient recruitment, and a significant disconnect between investigators' routine myositis patient load and clinical trial enrolment. MCTC will meet the need to support and diversify myositis clinical trials by facilitating trial planning, feasibility assessments, site selection, and the training and mentoring of junior investigators/centres to establish their readiness for clinical trial participation. Through experienced leadership, strategic collaborations, and interdisciplinary discussions, MCTC will establish standards for IIM clinical trial design, protocols, and outcome measures in myositis.

Aveiro Rheumatology Research Centre Egas Moniz Health Alliance Aveiro

Department of Allergy and Rheumatology Nippon Medical School Graduate School of Medicine Tokyo Japan

Department of Dermatology Venereology and Leprology Postgraduate Institute of Medical Education and Research Chandigarh India

Department of Medicine McGill University Montreal

Division of Infectious Diseases and International Health Duke University School of Medicine Durham NC USA

Division of Pulmonology and Critical Care Department of Medicine University of Florida College of Medicine Gainesville Florida USA

Division of Rheumatology and Clinical Immunology Department of Medicine The University of Hong Kong Hong Kong

Division of Rheumatology and Clinical Immunology University of Pittsburgh School of Medicine Pittsburgh PA

Division of Rheumatology and Clinical Immunology University of Pittsburgh School of Medicine Pittsburgh PA USA

Division of Rheumatology and Clinical Immunology University of Tangier Morocco

Division of Rheumatology Centre Hospitalier de l'Université de Montréal Canada

Division of Rheumatology Department of Internal Medicine National Taiwan University Hospital Hsin Chu Branch Taiwan

Division of Rheumatology Emory University Atlanta GA USA

Division of Rheumatology Jewish General Hospital Montreal Canada

Faculty of Health and Medical Sciences University of Adelaide and Rheumatology Unit Southern Adelaide Local Health Network Adelaide Australia

Institute of Rheumatology and Department of Rheumatology 1st Medical Faculty Charles University Prague Czech Republic

Interstitial Lung Disease and Rheumatology Unit Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas Mexico City Mexico

Manchester Centre for Clinical Neurosciences Northern Care Alliance NHS Foundation Trust Manchester Academic Health Science Centre Salford UK

RheumaCARE Mysuru India

Rheumatology Department Unidade Local de Saúde da Região de Aveiro Aveiro

Rheumatology Research Unit Instituto de Medicina Molecular Faculdade de Medicina Universidade de Lisboa Portugal

Rheumatology Unit Bnai Zion Medical Center Faculty of Medicine Technion Israel institute of technology Haifa Israel

Rheumatology Unit Department of Medicine Surgery and Neurosciences University of Siena Italy

Section of Rheumatology Department of Medicine Hospital Clínico Universidad de Chile Santiago Chile

References provided by Crossref.org

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$a Idiopathic inflammatory myopathies (IIM), or myositis, are a heterogeneous group of systemic autoimmune disorders that are associated with significant morbidity and mortality. Conducting high-quality clinical trials in IIM is challenging due to the rare and variable presentations of disease. To address this challenge, the Myositis Clinical Trials Consortium (MCTC) was formed. MCTC is a collaborative international alliance dedicated to facilitating, promoting, coordinating and conducting clinical trials and related research in IIM. This partnership works to advance the discovery of effective evidence-based treatments for IIM by integrating a diverse group of clinical investigators, research professionals, medical centres, patient groups, and industry partners. The Steering Committee, Core Group, and Paediatric Subcommittee of MCTC are comprised of myositis experts and junior investigators from around the world, representing a diversity of genders, geographies, and subspecialties. MCTC works alongside other current myositis organisations to complement existing work by concentrating on the operationalisation of clinical trials. Our pilot Myositis Investigators' Information Survey gathered responses from 173 myositis investigators globally and found considerable variability in proficiency with outcome measures, geographic disparities in patient recruitment, and a significant disconnect between investigators' routine myositis patient load and clinical trial enrolment. MCTC will meet the need to support and diversify myositis clinical trials by facilitating trial planning, feasibility assessments, site selection, and the training and mentoring of junior investigators/centres to establish their readiness for clinical trial participation. Through experienced leadership, strategic collaborations, and interdisciplinary discussions, MCTC will establish standards for IIM clinical trial design, protocols, and outcome measures in myositis.
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