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Special Article

 

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

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25
Collaborator/s: O. Benveniste1, D.B. De Araujo2, C. Charles-Schoeman3, H. Chinoy4, T.J. Corte5, M.M. Dimachkie6, R.P. Dodiuk-Gad7, P. Eichenbrenner8, M. Fujimoto9, I. García-De la torre10, N. Govind11, N.A. Goyal12, Z. Griger13, R.W. Hallowell14, M. Hudson15, V. Limaye16, L. Rajasekhar17, M. Lubinus18, I.E. Lundberg19, S. Malloy20, G. Marder21, L. Metni22, J. Myles23, M. Needham24, J. Raaphorst25, L.G. Rider26, J. Rojas-Serrano27, J. Schmidt28, A. Selva-O’callaghan29, S.K. Shinjo30, V. Shobha31, H. So32, I.B. Ventura33, S. Venuturupalli34, R.A. Vleugels35, G. Wang36, Q. Wang37, E.M. Wilfong38, B.M. Feldman39, A.M. Huber40, H. Kim41, S. Kim42, A. Ravelli43, A. Van royen-Kerkhof44

 

  1. Department of Dermatology, Venereology, and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
  2. Division of Rheumatology and Clinical Immunology, Department of Medicine, The University of Hong Kong, Hong Kong.
  3. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
  4. Division of Pulmonology and Critical Care, Department of Medicine, University of Florida College of Medicine, Gainesville, Florida, USA.
  5. Division of Rheumatology, Emory University, Atlanta, GA, USA.
  6. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
  7. RheumaCARE, Mysuru, India.
  8. Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico.
  9. Rheumatology Department, Unidade Local de Saúde da Região de Aveiro, Aveiro; Aveiro Rheumatology Research Centre, Egas Moniz Health Alliance, Aveiro; and Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Portugal.
  10. Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Italy.
  11. Section of Rheumatology, Department of Medicine, Hospital Clínico Universidad de Chile, Santiago, Chile.
  12. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
  13. Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK.
  14. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA; and Division of Infectious Diseases and International Health, Duke University School of Medicine, Durham, NC, USA.
  15. Division of Rheumatology, Centre Hospitalier de l'Université de Montréal, Canada.
  16. Division of Rheumatology and Clinical Immunology, University of Tangier, Morocco.
  17. Rheumatology Unit, Bnai Zion Medical Center, Faculty of Medicine, Technion Israel institute of technology, Haifa, Israel.
  18. Faculty of Health and Medical Sciences, University of Adelaide and Rheumatology Unit, Southern Adelaide Local Health Network, Adelaide, Australia.
  19. Division of Rheumatology, Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Taiwan.
  20. Department of Medicine, McGill University, Montreal; and Division of Rheumatology, Jewish General Hospital, Montreal, Canada.
  21. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
  22. Institute of Rheumatology and Department of Rheumatology, 1st Medical Faculty, Charles University, Prague, Czech Republic.
  23. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
  24. Division of Rheumatology, Emory University, Atlanta, GA, USA. prateek.gandiga@emory.edu
  25. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. aggarwalr@upmc.edu

  1. Department of Internal Medicine and Clinical Immunology, Pitié-Salpêtrière Hospital, Paris, France.
  2. Internal Medicine Department, Universidade Federal de Pelotas, Pelotas, Rio Grande do Sul, RS, Brazil.
  3. Department of Medicine, Division of Rheumatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, California, USA.
  4. Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Manchester Academic Health Science Centre, Salford, UK; Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
  5. Royal Prince Alfred Hospitaland, University of Sydney, Camperdown, Australia.
  6. Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
  7. Department of Dermatology, Emek Medical Center, Afula, Israel.
  8. The Myositis Association, Columbia, MD, USA.
  9. Department of Dermatology, Osaka University Graduate School of Medicine, Osaka, Japan.
  10. Departamento de Inmunología y Reumatología, Hospital General de Occidente de la S.S. y Universidad de Guadalajara, Zapopán, Jalisco, México.
  11. Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  12. Department of Neurology, University of California Irvine, Irvine, CA, USA.
  13. Faculty of Medicine, Division of Clinical Immunology, University of Debrecen, Hungary.
  14. Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
  15. Department of Medicine, Division of Rheumatology, McGill University, Montreal, Canada; Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.
  16. Rheumatology Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Discipline of Medicine, Adelaide University, Adelaide, South Australia, Australia.
  17. Department of Clinical Immunology & Rheumatology, Nizam Institute of Medical Sciences, Hyderabad, India.
  18. Myositis Support And Understanding Association, Lincoln, DE, USA.
  19. Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
  20. Cure JM Foundation, Leesburg, VA, USA.
  21. Department of Rheumatology, Northwell Health, Great Neck, NY, USA.
  22. Cure JM Foundation, Leesburg, VA, USA.
  23. The Myositis Association, Columbia, MD, USA.
  24. Department of Neurology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia; Centre for Molecular, Medicine, Murdoch University, Perth, Western Australia, Australia; Department of Neurology, Perron Institute for Neurological and Translational Science, Nedlands, Western Australia, Australia; Department of Neurology, University of Notre Dame, Fremantle, Western Australia, Australia.
  25. Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, the Netherlands.
  26. Environmental Autoimmunity Group, Clinical Research Branch, National Institute of Environmental Health Sciences, National Institutes of Health, Bethesda, MD, USA.
  27. Interstitial Lung Disease and Rheumatology Units, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City, Mexico.
  28. Department of Neurology, Neuromuscular Center, University Medical Center Göttingen, Göttingen, Germany; Department of Neurology and Pain Treatment, Neuromuscular Center, Center for Translational Medicine, Immanuel Klinik Rüdersdorf, University Hospital of the Brandenburg Medical School; and Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Rüdersdorf bei Berlin, Germany.
  29. Systemic Autoimmune Diseases Unit, Internal Medicine Department, Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
  30. Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
  31. Department of Clinical Immunology and Rheumatology, St. John's Medical College Hospital, Bengaluru, India.
  32. Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
  33. Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.
  34. Division of Rheumatology, Department of Medicine, Cedars-Sinai Medical Center, Beverly Hills, CA, USA.
  35. Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA; Division of Allergy, Immunology and Rheumatology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
  36. Department of Rheumatology, Key Myositis Laboratories, China-Japan Friendship Hospital, Beijing, China.
  37. Department of Rheumatology and Clinical Immunology, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
  38. Division of Rheumatology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
  39. Division of Rheumatology, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.
  40. Department of Pediatrics, Dalhousie University, Halifax, NS, Canada; Division of Pediatric Rheumatology, IWK Health, Halifax, NS, Canada.
  41. Juvenile Myositis Pathogenesis and Therapeutics Unit, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Maryland, USA.
  42. Department of Pediatrics, Division of Rheumatology, University of California San Francisco Benioff Children's Hospital, San Francisco.
  43. Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili (DiNOGMI), Università degli Studi di Genova, Genova, Italy; Scientific Direction, IRCCS Istituto Giannina Gaslini, Genova, Italy.
  44. Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.

on behalf of the Myositis Clinical Trials Consortium investigators

CER18342
2025 Vol.43, N°2
PI 0202, PF 0210
Special Article

Free to view
(click on article PDF icon to read the article)

PMID: 39977016 [PubMed]

Received: 15/11/2024
Accepted : 16/12/2024
In Press: 20/02/2025
Published: 26/02/2025

Abstract

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.

DOI: https://doi.org/10.55563/clinexprheumatol/k7665a

Rheumatology Article