Clinical trial NCT05523167: A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
Official title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Active Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Polymyositis
Immune-Mediated Necrotizing Myopathy
Antisynthetase Syndrome
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2022-08-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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). Additional information can be found on https://myositis-study.com/.


Eligibility criteria: 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).

The full list of inclusion criteria can be found in the protocol.

Exclusion Criteria:

* A clinically significant active infection at screening
* A COVID-19 polymerase chain reaction (PCR)-positive test before enrollment
* 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
* Juvenile myositis (JDM) diagnosed \> 5 years from screening or juvenile myositis with extensive calcinosis or severe calcinosis.
* 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
* Other inflammatory and noninflammatory myopathies: inclusion body myositis, overlap myositis), metabolic myopathies, muscle dystrophies or a family history of muscle dystrophy, drug-induced or endocrine induced myositis, and juvenile myositis (other than juvenile dermatomyositis (JDM))
* Clinically significant disease, recent major surgery or intends to have surgery during the study, or has any other condition in the opinion of the investigator that could confound the results of the trial or put the patient at undue risk
* Known hypersensitivity reaction to investigational medicinal product (IMP) or 1 of its excipients
* Received a live or live-attenuated vaccine less than 4 weeks before screening.
* Positive serum test at screening for active viral infection with any of the following conditions: Hepatitis B virus (HBV); Hepatitis C virus (HCV); HIV
* Participant has previously participated in an efgartigimod clinical trial and received at least 1 dose of investigational medicinal product (IMP).
* Participant is concurrently participating in any other clinical study, including a noninterventional study.
* Participant has a current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse.
* Participant is pregnant or lactating or intends to become pregnant during the study.
* Participant has severe renal impairment .
* Participant is institutionalized by a court or other governmental order or is in a dependent relationship with the sponsor or investigator.

The full list of exclusion criteria can be found in the protocol.

Primary outcomes:
measure: Total improvement score (TIS); measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
Secondary outcomes:
measure: Time to reach TIS ≥ 20 (first "minimal clinical improvement")
timeFrame: phase 2: up to 24 weeks; phase 3: up to 52 weeks
measure: Percentage of participants with TIS ≥ 20
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
measure: Time to reach TIS ≥ 40 (first "moderate clinical improvement")
timeFrame: phase 2: up to 24 weeks; phase 3: up to 52 weeks
measure: Percentage of participants with TIS ≥ 40
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
measure: Change in manual muscle testing-8 (MMT8) score
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
measure: Change in Patient Global Assessment of Disease Activity (PGA)
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
measure: Change in Physician Global Assessment of Disease Activity (MDGA)
timeFrame: phase 2: 24 weeks; phase 3: 52 weeks
measure: Proportion of participants achieving target dose of ≤ 5 mg (prednisone equivalent)
timeFrame: Phase 3: 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Neuromuscular Research Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Neurology - Bob Bove Neuroscience Institute - Neurology
state: Arizona
city: Beverly Hills
country: United States
facility: Attune Health Research, Inc
state: California
city: Los Angeles
country: United States
facility: University of Southern California Norris Comprehensive Cancer Center
state: California
city: Oceanside
country: United States
facility: Profound Research LLC - Oceanside
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Health
state: California
city: San Francisco
country: United States
facility: Amyotrophic Lateral Sclerosis (ALS) Treatment Center,University of California San Francisco (UCSF)
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: New Haven
country: United States
facility: Yale Cancer Center-Yale University School Of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: UF Health Rheumatology
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Tampa
country: United States
facility: University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital, The Emory Clinic
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Medicine - Johns Hopkins Myositis Center
state: Maryland
city: Boston
country: United States
facility: Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Research Center (TRC)
state: Massachusetts
city: East Lansing
country: United States
facility: Michigan State University - Neurology
state: Michigan
city: Saint Paul
country: United States
facility: St. Paul Rheumatology, PA
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) School of Medicine
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Main Campus
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Hospital - Mercy Clinic Neurology Oklahoma City - Neurology
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center (VUMC) - Vanderbilt Rheumatology Clinic
state: Tennessee
city: Austin
country: United States
facility: Austin Neuromuscular Center
state: Texas
city: Houston
country: United States
facility: McGovern Medical School -The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: Nerve And Muscle Center Of Texas
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center - Main Campus
state: Vermont
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Córdoba
country: Argentina
facility: Consultora Integral de Salud
city: La Plata
country: Argentina
facility: Framingham Centro Medico
city: Ramos Mejía
country: Argentina
facility: Dim Clinica Privada
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: San Miguel
country: Argentina
facility: Centro Dermatologico Schejtman
city: Auchenflower
country: Australia
facility: The Wesley Medical Research
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
city: Charleroi
country: Belgium
facility: Centre Hospitalier Universitaire de Charleroi
city: Gent
country: Belgium
facility: AZ Sint Lucas Gent-Campus Sint Lucas
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven Gasthuisberg Campus
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven Gasthuisberg Campus
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman
city: Plovdiv
country: Bulgaria
facility: Medical Centre Artmed
city: Plovdiv
country: Bulgaria
facility: Multiprofile hospital for active treatment Kaspela EOOD
city: Montréal
country: Canada
facility: Genge Partners
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute-Civic Campus
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital - School of Medicine - ZheJiang University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Renji Hospital
city: Shanxi
country: China
facility: First Affiliated Hospital of Shanxi Medical College
city: Shenyang
country: China
facility: China Medical University (CMU) - First Affiliated Hospital
city: Wuhan
country: China
facility: Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital
city: Zhengzhou
country: China
facility: First Affiliated Hospital (Henan Medical University - First Affiliated Hospital)-Zhengzhou University
city: Nicosia
country: Cyprus
facility: Cyprus Institute of Neurology and Genetics
city: Praha
country: Czechia
facility: Revmatologicky ustav
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital-Rigshospitalet University Hospital
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
facility: Reference Center Neuro-Muscular Diseases - CHU Paris Group Hospitalier La Pitie Salpetriere-Charles Foix
city: Rouen
country: France
facility: Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes
city: Tbilisi
country: Georgia
facility: American Hospital Network
city: Tbilisi
country: Georgia
facility: LTD New Hospitals
city: Tbilisi
country: Georgia
facility: Aversi Clinic
city: Tbilisi
country: Georgia
facility: LLC MediClub Georgia
city: Tbilisi
country: Georgia
facility: The First Medical Center
city: Tbilisi
country: Georgia
facility: LTD Tbilisi Heart Center
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen - Georg-August-Universitat
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Mannheim
country: Germany
facility: Universitatsmedizin Mannheim
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitat Munchen Friedrich-Baur-Institut Neurologische Klinik und Poliklinik
city: Sendenhorst
country: Germany
facility: St. Josef-Stift Sendenhorst
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen (UKT)
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm - Standort Oberer Eselsberg
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens - Eginition Hospital
city: Athens
country: Greece
facility: Attikon General University Hospital
city: Athens
country: Greece
facility: Athens Medical Center
city: Ioánnina
country: Greece
facility: University of Ioannina Medical School
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Institute of Genomic Medicine and Rare Disorders
city: Debrecen
country: Hungary
facility: Debreceni Egyetem - University of Debrecen
city: Dublin
country: Ireland
facility: St. Vincents University Hospital
city: Dublin
country: Ireland
facility: Connolly Hospital Blanchardstown
city: Manorhamilton
country: Ireland
facility: North West Rheumatology Unit - Our Lady's Hospital
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - Rheumatology
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari - Rheumatology
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milan
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele Hospital
city: Pavia
country: Italy
facility: San Matteo Hospital
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: IRCCS Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Andrea
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas - Rheumatology
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
city: Udine
country: Italy
facility: ASU FC - Presidio Ospedaliero Universitario Santa Maria della Misericordia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School - Nippon Medical School Hospital
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
city: Matsudo-shi
country: Japan
facility: Chiba-Nishi General Hospital
city: Nagoya
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital (KUH)
city: Sapporo-shi
country: Japan
facility: Sapporo City Hospital
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital - Rheumatology
city: Sasebo-shi
country: Japan
facility: Sasebo Chuo Hospital
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital - Rheumatology
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital - Rheumatology
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital - Dermatology
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNUH)
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Mexico City
country: Mexico
facility: CITER - Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S.A. de C.V.
city: Mérida
country: Mexico
facility: Centro Peninsular De Investigacion Clinica
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht (UMC Utrecht)
city: Arequipa
country: Peru
facility: Hogar Clinica San Juan de Dios
city: Lima
country: Peru
facility: Investigaciones Clinicas S.A.C.
city: Lima
country: Peru
facility: Instituto Peruano Del Hueso Y La Articulacion Sac-Privado-Lima, Centro De Investigacion Iphar
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Szczecin
country: Poland
facility: Centrum Wsparcia Badan Klinicznych Pomorski Uniwersytet Medyczny w Szczecinie
city: Łódź
country: Poland
facility: USK-WAM Centralny Szpital Weteranow - Szpital Kniniczny ul. Zeromskiego 113
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E- Hospital Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Santo Antonio
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrad
country: Serbia
facility: Institute of Rheumatology
city: Piešťany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona - Sede Villarroel - Rheumatology
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital De Valme
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Vigo
country: Spain
facility: Hospital Do Meixoeiro
city: Stockholm
country: Sweden
facility: Karolinska Universitestssjukhus Solna
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland
city: Taichung city
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: China Medical University and Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn University - Faculty of Medicine - King Chulalongkorn Memorial Hospital (KCMH)
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University of Internal medicine
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
city: Pathum Thani
country: Thailand
facility: Thammasat University Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Konya
country: Turkey
facility: Necmettin Erbakan University Meram Medical Faculty
city: Bath
country: United Kingdom
facility: Royal National Hospital for Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary - Doncaster And Bassetlaw Hospitals Nhs Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Institute of Rheumatic & Musculoskeletal Medicine - University of Leeds
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital - Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal Free Hospital - Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: The National Hospital for Neurology and Neurosurgery
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital - South Tees Hospitals NHS Foundation Trust
city: Salford
country: United Kingdom
facility: Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Study officials:
References: