활동성 특발성 염증성 근병증이 있는 성인 참가자에서 Efgartigimod PH20 SC의 효능 및 안전성을 조사하기 위한 연구. (ALKIVIA)
2026년 9월 18일 업데이트: argenx
참가자를 대상으로 Efgartigimod PH20 SC의 효능, 안전성, 내약성, 약력학, 약동학 및 면역원성을 평가하기 위한 2/3상, 무작위, 이중 맹검, 위약 대조, 병렬 그룹, 2군, 다기관, 운영상 원활한 연구 활동성 특발성 염증성 근육병증이 있는 18세 이상
This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS).
연구 개요
연구 유형
중재적
등록 (실제)
265
단계
- 2 단계
- 3단계
연락처 및 위치
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연구 장소
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Tbilisi, 그루지야, 0160
- Aversi Clinic
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Tbilisi, 그루지야, 0180
- The First Medical Center
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Tbilisi, 그루지야, 0114
- LTD New Hospitals
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Tbilisi, 그루지야, 0186
- LTD Tbilisi Heart Center
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Tbilisi, 그루지야, 0102
- American Hospital Network
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Tbilisi, 그루지야, 0179
- LLC MediClub Georgia
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Athens, 그리스, 115 27
- National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
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Athens, 그리스, 115 28
- National and Kapodistrian University of Athens - Eginition Hospital
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Athens, 그리스, 151 25
- Athens Medical Center
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Athens, 그리스, 12462
- Attikon General University Hospital
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Ioannina, 그리스, 45110
- University of Ioannina Medical School
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Amsterdam, 네덜란드, 1105 AZ
- Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
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Utrecht, 네덜란드, 3584 CX
- Universitair Medisch Centrum Utrecht (UMC Utrecht)
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taichung, 대만, 402
- Chung Shan Medical University Hospital
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Taichung, 대만, 40402
- China Medical University and Hospital
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Daejeon, 대한민국, 35015
- Chungnam National University Hospital (CNUH)
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Incheon, 대한민국, 21565
- Gachon University Gil Medical Center
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 02447
- Kyung Hee University Medical Center
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Seoul, 대한민국, 04763
- Hanyang University Seoul Hospital
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Suwon, 대한민국, 16499
- Ajou University Hospital
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Copenhagen, 덴마크, 2100
- Copenhagen University Hospital-Rigshospitalet University Hospital
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Berlin, 독일, 10117
- Charite - Universitaetsmedizin Berlin
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Düsseldorf, 독일, 40225
- Universitaetsklinikum Duesseldorf
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Göttingen, 독일, 37075
- Universitatsmedizin Gottingen - Georg-August-Universitat
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Hamburg, 독일, 20246
- Universitaetsklinikum Hamburg-Eppendorf
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Herne, 독일, 44649
- Rheumazentrum Ruhrgebiet
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Mannheim, 독일, 68167
- Universitatsmedizin Mannheim
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München, 독일, 80336
- Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
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Sendenhorst, 독일, 48324
- St. Josef-Stift Sendenhorst
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Tübingen, 독일, 72076
- Universitaetsklinikum Tuebingen (UKT)
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Ulm, 독일, 89081
- Universitatsklinikum Ulm - Standort Oberer Eselsberg
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Kaunas, 리투아니아, 50161
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Vilnius, 리투아니아, 08661
- Vilnius University Hospital Santaros Klinikos
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Mexico City, 멕시코, 06700
- CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
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Mérida, 멕시코, 97000
- Centro Peninsular De Investigacion Clinica
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Arizona
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Phoenix, Arizona, 미국, 85028
- Neuromuscular Research Center
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Scottsdale, Arizona, 미국, 85251
- HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
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California
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Beverly Hills, California, 미국, 90039
- Attune Health Research, Inc
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Los Angeles, California, 미국, 90033
- University of Southern California Norris Comprehensive Cancer Center
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Oceanside, California, 미국, 92056
- Profound Research LLC - Oceanside
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Orange, California, 미국, 92868
- University of California, Irvine
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Rancho Mirage, California, 미국, 92270
- Eisenhower Medical Center
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Redwood City, California, 미국, 94063-3132
- Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
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San Francisco, California, 미국, 94109
- California Pacific Medical Center - Sutter Health
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San Francisco, California, 미국, 94143-2202
- Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
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Colorado
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Denver, Colorado, 미국, 80230
- Denver Arthritis Clinic
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale Cancer Center-Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- Georgetown University Hospital
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Florida
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Gainesville, Florida, 미국, 32610-3008
- UF Health Rheumatology
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic
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Tampa, Florida, 미국, 33616
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital, The Emory Clinic
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Augusta, Georgia, 미국, 30312
- Augusta University
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital
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Kansas
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Kansas City, Kansas, 미국, 66160
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Maryland
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Medicine - Johns Hopkins Myositis Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115-6110
- Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
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Michigan
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East Lansing, Michigan, 미국, 48824
- Michigan State University - Neurology
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Minnesota
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Saint Paul, Minnesota, 미국, 55121
- St. Paul Rheumatology, PA
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Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New York
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Great Neck, New York, 미국, 11021
- Northwell Health
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New York, New York, 미국, 10021
- Hospital for Special Surgery
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North Carolina
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Chapel Hill, North Carolina, 미국, 27514-4220
- University of North Carolina (UNC) School of Medicine
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Wilmington, North Carolina, 미국, 28401
- Carolina Arthritis Associates
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic - Main Campus
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Columbus, Ohio, 미국, 43201
- The Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73120
- Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15261
- University of Pittsburg Medical Center
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Tennessee
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Nashville, Tennessee, 미국, 37232-0028
- Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
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Texas
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Austin, Texas, 미국, 78759
- Austin Neuromuscular Center
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Houston, Texas, 미국, 77030
- McGovern Medical School -The University of Texas Health Science Center at Houston
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Houston, Texas, 미국, 77030
- Nerve And Muscle Center Of Texas
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Vermont
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Burlington, Vermont, 미국, 05401
- University of Vermont Medical Center - Main Campus
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington Medical Center
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Charleroi, 벨기에, 6042
- Centre Hospitalier Universitaire de Charleroi
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Ghent, 벨기에, 9000
- AZ Sint Lucas Gent-Campus Sint Lucas
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Leuven, 벨기에, 3000
- Universitair Ziekenhuis Leuven Gasthuisberg Campus
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Liège, 벨기에, 4000
- Centre Hospitalier Universitaire Sart Tilman
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Plovdiv, 불가리아, 4002
- Multiprofile hospital for active treatment Kaspela EOOD
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Plovdiv, 불가리아, 4002
- Medical Centre Artmed
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Belgrade, 세르비아, 11000
- Clinical Center of Serbia
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Belgrade, 세르비아, 11000
- Institute of Rheumatology
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Stockholm, 스웨덴, 17164
- Karolinska Universitestssjukhus Solna
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Lugano, 스위스, 6900
- Neurocenter of Southern Switzerland
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Alicante, 스페인, 03010
- Hospital General Universitario de Alicante
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Barcelona, 스페인, 08036
- Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
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Barcelona, 스페인, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, 스페인, 28034
- Hospital Universitario Ramon y Cajal
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Madrid, 스페인, 28046
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Madrid, 스페인, 451086
- Hospital Universitario 12 de Octubre
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Seville, 스페인, 9-41014
- Hospital De Valme
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Valencia, 스페인, 46026
- Hospital Universitario y Politecnico La Fe
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Vigo, 스페인, 36200
- Hospital Do Meixoeiro
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Piešťany, 슬로바키아, 92112
- Narodny ustav reumatickych chorob
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Córdoba, 아르헨티나, 5000
- Consultora Integral de Salud
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La Plata, 아르헨티나, B1902COS
- Framingham Centro Medico
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Ramos Mejía, 아르헨티나, B1704ETD
- Dim Clinica Privada
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San Miguel, 아르헨티나, B1663GKT
- Centro Dermatologico Schejtman
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San Miguel de Tucumán, 아르헨티나, T4000AXL
- Centro de Investigaciones Medicas Tucuman
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Dublin, 아일랜드, D04 T6F4
- St. Vincents University Hospital
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Dublin, 아일랜드, D15 X40D
- Connolly Hospital Blanchardstown
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Manorhamilton, 아일랜드, F91 X012
- North West Rheumatology Unit - Our Lady's Hospital
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Bath, 영국, BA1 3NG
- Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
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Doncaster, 영국, DN2 5LT
- Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
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Leeds, 영국, LS7 4SA
- Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
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Liverpool, 영국, L9 7AL
- Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
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London, 영국, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, 영국, WC1N 3BG
- The National Hospital for Neurology and Neurosurgery
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London, 영국, NW3 2QG
- The Royal Free Hospital - Royal Free London NHS Foundation Trust
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Middlesbrough, 영국, TS4 3BW
- James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
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Salford, 영국, M6 8HD
- Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
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Innsbruck, 오스트리아, 6020
- Medical University Innsbruck
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Vienna, 오스트리아, 1090
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campus
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Haifa, 이스라엘, 31048
- Bnai Zion Medical Center
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Kfar Saba, 이스라엘, 44281
- Meir Medical Center
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
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Ramat Gan, 이스라엘, 52621
- Sheba Medical Center - Rheumatology
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Bari, 이탈리아, 70124
- Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
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Florence, 이탈리아, 50139
- Azienda Ospedaliero Universitaria Careggi
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Milan, 이탈리아, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
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Pavia, 이탈리아, 27100
- San Matteo Hospital
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Pisa, 이탈리아, 56126
- A.O. Universitaria Pisana
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Reggio Emilia, 이탈리아, 42123
- IRCCS Arcispedale Santa Maria Nuova
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Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
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Roma, 이탈리아, 00189
- Azienda Ospedaliero Universitaria Sant'Andrea
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Rozzano, 이탈리아, 20089
- IRCCS Istituto Clinico Humanitas - Rheumatology
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Torino, 이탈리아, 10126
- Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
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Udine, 이탈리아, 33100
- ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
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Verona, 이탈리아, 37134
- Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
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Bunkyō City, 일본, 113-8519
- Tokyo Medical And Dental University Hospital, Faculty of Medicine
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Bunkyō City, 일본, 113-8603
- Nippon Medical School - Nippon Medical School Hospital
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Kawasaki, 일본, 216-8511
- St. Marianna University School of Medicine Hospital
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Kurume, 일본, 830-0011
- Kurume University Hospital
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Matsudo-shi, 일본, 270-2251
- Chiba-Nishi General Hospital
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Nagoya, 일본, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Sagamihara-shi, 일본, 252-0375
- Kitasato University Hospital (KUH)
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Sapporo, 일본, 060-8604
- Sapporo City Hospital
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Sapporo, 일본, 060-8648
- Hokkaido University Hospital - Rheumatology
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Sasebo-shi, 일본, 857-1165
- Sasebo Chuo Hospital
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Sendai, 일본, 980-8574
- Tohoku University Hospital
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Tokushima, 일본, 770-8503
- Tokushima University Hospital
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Tokyo, 일본, 160-8582
- Keio University Hospital
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Tokyo, 일본, 113-8655
- The University of Tokyo Hospital
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Tokyo, 일본, 113-8431
- Juntendo University Hospital - Rheumatology
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Tsukuba, 일본, 305-8576
- University of Tsukuba Hospital - Rheumatology
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Ube-shi, 일본, 755-8505
- Yamaguchi University Hospital
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Wakayama, 일본, 641-8509
- Wakayama Medical University Hospital - Dermatology
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Beijing, 중국, 100730
- Peking Union Medical College Hospital
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Beijing, 중국, 100191
- Peking University Third Hospital
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Beijing, 중국, 100034
- Peking University First Hospital
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Changchun, 중국, 130021
- The First Hospital of Jilin University
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Changsha, 중국, 410008
- Xiangya Hospital Central South University
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Changsha, 중국, 410011
- The Second Xiangya Hospital of Central South University
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Chengdu, 중국, 610072
- Sichuan Provincial Peoples Hospital
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Guangzhou, 중국, 510515
- Nanfang Hospital, Southern Medical University
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Guangzhou, 중국, 510000
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Hangzhou, 중국, 310003
- The First Affiliated Hospital - School of Medicine - ZheJiang University
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Hefei, 중국, 230001
- Anhui Provincial Hospital
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Nanchang, 중국, 330000
- The Second Affiliated Hospital Of Nanchang University
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Nanjing, 중국, 210008
- Nanjing Drum Tower Hospital
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Shanghai, 중국, 200025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, 중국, 200127
- Shanghai Renji Hospital
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Shanghai, 중국, 200000
- Huashan Hospital Affiliated to Fudan University
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Shanxi, 중국, 30001
- First Affiliated Hospital of Shanxi Medical College
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Shenyang, 중국, 110001
- China Medical University (CMU) - First Affiliated Hospital
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Wuhan, 중국, 430030
- Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
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Zhengzhou, 중국, 450052
- First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
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Prague, 체코, 128 00
- Revmatologicky ustav
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Montreal, 캐나다, H4A 3T2
- Genge Partners
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Ottawa, 캐나다, K1Y 4E9
- Ottawa Hospital Research Institute-Civic Campus
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Nicosia, 키프로스, 2371
- Cyprus Institute of Neurology and Genetics
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Bangkok, 태국, 10400
- Phramongkutklao Hospital
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Bangkok, 태국, 10700
- Siriraj Hospital, Mahidol University of Internal medicine
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Bangkok, 태국, 10300
- Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
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Bangkok, 태국, 10400
- Ramathibodi hospital
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Chiang Mai, 태국, 50200
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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Khon Kaen, 태국, 40000
- Khon Kaen University
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Pathum Thani, 태국, 12120
- Thammasat University Hospital
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Ankara, 터키 (Türkiye), 06800
- Ankara City Hospital
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Ankara, 터키 (Türkiye), 06230
- Ankara University Medical Faculty
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Konya, 터키 (Türkiye), 42090
- Necmettin Erbakan University Meram Medical Faculty
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Arequipa, 페루, 4018
- Hogar Clinica San Juan de Dios
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Lima, 페루, 31
- Hospital Nacional Cayetano Heredia
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Lima, 페루, 15023
- Investigaciones Clinicas S.A.C.
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Lima, 페루, 27
- Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
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Lisbon, 포르투갈, 1649-035
- Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
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Porto, 포르투갈, 4099-001
- Centro Hospitalar Universitario de Santo Antonio
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Bydgoszcz, 폴란드, 85-168
- Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
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Lodz, 폴란드, 90-549
- USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
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Szczecin, 폴란드, 71-252
- Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
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Lyon, 프랑스, 69003
- Hopital Edouard Herriot
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Paris, 프랑스, 75013
- Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
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Rouen, 프랑스, 76031
- Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
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Strasbourg, 프랑스, 67098
- Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
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Budapest, 헝가리, 1083
- Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
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Debrecen, 헝가리, 4032
- Debreceni Egyetem - University of Debrecen
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Auchenflower, 호주, 4066
- The Wesley Medical Research
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Murdoch, 호주, 6150
- Fiona Stanley Hospital
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공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Ability to consent in the jurisdiction in which the study is taking place and capable of giving signed informed consent.
- A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM)
- One of the following medical histories: Diagnosis of dermatomyositis (DM) or juvenile dermatomyositis (JDM), Diagnosis of polymyositis (PM) (including antisynthetase syndrome (ASyS)), Diagnosis of immune-mediated necrotizing myopathy (IMNM)
- Diagnosed with active disease as defined by the presence of at least 1 of the following criteria: Abnormal levels of at least 1 of the following enzymes: creatine kinase (CK), aldolase, lactate dehydrogenase, aspartate aminotransaminase (AST), alanine aminotransferase (ALT), based on central laboratory results; Electromyography demonstrating active disease within the past 3 months; Active dermatomyositis (DM) skin rash; Muscle biopsy indicative of active idiopathic inflammatory myopathy (IIM) in the past 3 months; Magnetic resonance imaging within the past 3 months indicative of active inflammation
- Muscle weakness
- Receiving a permitted background treatment for idiopathic inflammatory myopathy.
- Contraceptive use consistent with local regulations, where available, for individuals participating in clinical studies. Women of childbearing potential must have a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Exclusion Criteria:
- Any other known autoimmune disease that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of idiopathic inflammatory myopathy (IIM) or put the patient at undue risk
- A history of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for ≥ 3 years before the first administration of the investigational medicinal product (IMP). Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer ; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
- Severe muscle damage
- Glucocorticoid-induced myopathy that the investigator considers the primary cause of muscle weakness or permanent weakness linked to a non-idiopathic inflammatory myopathy (IIM) cause
- Uncontrolled interstitial lung disease or any other uncontrolled idiopathic inflammatory myopathy (IIM) manifestation that, in the opinion of the investigator, would be likely to require treatment with prohibited medication during the study
- Participant is pregnant or lactating or intends to become pregnant during the study.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment |
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
위약 비교기: PBO PH20 SC
participants receiving placebo PH20 SC on top of background treatment |
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mean TIS
기간: phase 2: 24 weeks; phase 3: 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: 24 weeks; phase 3: 52 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to reach TIS ≥ 20 (first "minimal clinical improvement")
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Percentage of participants with TIS ≥ 20
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Time to reach TIS ≥ 40 (first "moderate clinical improvement")
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Percentage of participants with TIS ≥ 40
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in MMT8 score
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The manual muscle testing-8 (MMT8) is a physician assessment of muscle strength in a set of 8 designated muscles tested bilaterally and axially. The highest total potential MMT8 score is 150 |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in Patient Global Assessment of Disease Activity (PGA)
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Patient Global Assessment of Disease Activity (PGA) is a tool that measures a patient's global evaluation of their overall disease activity at the time of assessment using a 10-cm VAS. The participant rates their overall disease activity by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity) to the right end of the line (extremely active or severe disease activity). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Change in Physician Global Assessment of Disease Activity (MDGA)
기간: phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
The Physician Global Assessment of Disease Activity (MDGA) is a tool that measures the physician's global evaluation of the participant's overall disease activity, defined as potentially reversible pathology or physiology resulting from IIM. The physician rates disease activity on the MDGA using a 10-cm VAS. Overall disease activity is rated by drawing a vertical mark on a 10-cm VAS from the left end of the line (no evidence of disease activity), midpoint of the line (moderate disease activity), and the right end of the line (extremely active or severe disease activity). |
phase 2: up to 24 weeks; phase 3: up to 52 weeks
|
|
Proportion of participants who have at least moderate improvement (≥40) in TIS at week 52 and adhere to an oral prednisone dosage of ≤5 mg/day (or equivalent) from week 44 onward
기간: Phase 3: up to 52 weeks
|
The Total improvement score (TIS) assesses minimal, moderate, and major clinical response, and is assessed using the ACR/EULAR criteria. It is measured on a 0 to 100 scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline). |
Phase 3: up to 52 weeks
|
|
Change in CK abnormality grades at week 52
기간: Phase 3: up to 52 weeks
|
CK: creatine kinase |
Phase 3: up to 52 weeks
|
|
Change in CDASI activity score at week 52
기간: Phase 3: up to 52 weeks
|
The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a skin-specific outcome measure used to assess disease in patients with Dermatomyositis (DM). Disease in 15 different anatomical locations is rated using 3 activity measures (erythema, scale, erosion/ulceration) and 2 damage measures (poikiloderma, calcinosis). The resulting activity and damage scores range from 0 to 100 and 0 to 32, respectively. Higher scores indicate greater disease severity. |
Phase 3: up to 52 weeks
|
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
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추가 정보
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