Clinical trial NCT04961567: A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lupus Erythematosus, Systemic
Keywords: Lupus
SLE
CLE
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 540
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: In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants.

The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is:

- How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS).

Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires.

The study will be done as follows:

* After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine.
* All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications.
* Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo.
* There will be a follow-up safety period that lasts up to 24 weeks.
* In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.


Eligibility criteria: Key Inclusion Criteria:

* Participant must be diagnosed with SLE at least 24 weeks prior to screening and must meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE, at screening by a qualified physician.
* Participant has a modified Systemic Lupus Erythematosus Disease Activity Index-200 (SLEDAI-2K) score ≥6 (excluding alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated).
* Participant has a modified clinical SLEDAI-2K score ≥4 (excluding anti-dsDNA, low complement component 3 \[C3\] and/or complement component 4 \[C4\], alopecia, fever, lupus-related headache, and organic brain syndrome) at screening (adjudicated) and randomization.
* Participant has BILAG-2004 grade A in ≥1 organ system or BILAG-2004 grade B in ≥2 organ systems at screening (adjudicated) and randomization.
* Participants must be treated with one of the following background nonbiologic lupus SOC therapies, initiated ≥12 weeks prior to screening and at stable dose ≥4 weeks prior to randomization:

  1. Antimalarials as stand-alone treatment
  2. Antimalarial treatment in combination with OCS and/or a single immunosuppressant
  3. Treatment with OCS and/or a single immunosuppressant.

Key Exclusion Criteria:

* History of or positive test result for human immunodeficiency virus (HIV).
* Current hepatitis C infection (defined as positive hepatitis C virus \[HCV\] antibody and detectable HCV ribonucleic acid \[RNA\]).
* Current hepatitis B infection (defined as positive for antibody to hepatitis B surface antigen \[HBsAg\] and/or positive for total antibody to hepatitis B core antigen \[anti-HBc\] with positive reflex HBV DNA).
* History of severe herpes infection.
* Presence of uncontrolled or New York Heart Association class III or IV congestive heart failure.
* Active severe lupus nephritis where, in the opinion of the investigator, protocol-specified SOC is insufficient and use of a more aggressive therapeutic approach, such as adding intravenous (IV) cyclophosphamide and/or high-dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated; or urine protein-creatinine ratio \>2.0 or severe chronic kidney disease (estimated glomerular filtration rate \<30 milliliters per minute per 1.73 meter square \[mL/min/1.73 m\^2\]) calculated using the abbreviated Modification of Diet in Renal Disease equation.
* Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
* History or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome.
* Active neuropsychiatric SLE.
* Use of oral prednisone (or equivalent) above 20 mg/day.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved an SRI-4 Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
timeFrame: Week 52
measure: Percentage of Participants with OCS ≥10 milligrams per day (mg/day) at Baseline Who Have OCS Reduction to ≤7.5 mg/day at Week 40, Which Is Sustained Through Week 52 with No Disease Worsening from Week 40 to Week 52
timeFrame: Week 40 up to Week 52
measure: Percentage of Participants with a CLASI-A Score ≥10 at Baseline Who Achieved a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI-50) Response at Week 16
timeFrame: Week 16
measure: Annualized Flare Rate Through Week 52
timeFrame: Up to Week 52
measure: Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
timeFrame: Up to Week 52
measure: Time to Onset of SRI-4 Response Sustained Through Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Joint-50 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
timeFrame: Up to Week 52
measure: Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit
timeFrame: Up to Week 52
measure: Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
timeFrame: Up to Week 52
measure: Time to First Severe Flare as Defined by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI)
timeFrame: Up to Week 52
measure: Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
timeFrame: Up to Week 52
measure: Percentage of Participants With Sustained LLDAS as Defined by the Number of Participants With ≥ 3, ≥ 5, and ≥ 7 Consecutive Visits in LLDAS up to and Including Week 52
timeFrame: Up to Week 52
measure: Percentage of Participants who Achieved LLDAS at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
timeFrame: Week 52
measure: Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
timeFrame: Up to Week 52
measure: Change from Baseline in Short Form Health Survey-36 (SF-36) Score
timeFrame: Up to Week 52
measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: Up to Week 52
measure: Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Up to Week 52
measure: Change from Baseline in Work Productivity and Activity Impairment (WPAI): Lupus Score
timeFrame: Up to Week 52
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 52
measure: Number of Participants with Antibodies to Litifilimab
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Huntington Beach
country: United States
facility: Care Access Research - Huntington BeachCare Access Research - Huntington Beach
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group
state: California
city: Los Angeles
country: United States
facility: The Practice of Medicine
state: California
city: Monterey Park
country: United States
facility: R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
state: California
city: Napa
country: United States
facility: Neurovations
state: California
city: Orange
country: United States
facility: Joo-Hyung Lee MD
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Boca Raton
country: United States
facility: RASF - Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kissimmee
country: United States
facility: Vida Clinical Research
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: HMD Research, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic Emory University
state: Georgia
city: Decatur
country: United States
facility: Jefrey Lieberman, M.D., P.C.
state: Georgia
city: Gainesville
country: United States
facility: Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
state: Georgia
city: Gainesville
country: United States
facility: RNA America Health Sciences
state: Georgia
city: Snellville
country: United States
facility: EBGS Clinical Trials
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Brookline
country: United States
facility: DM Clinical Research - Boston
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis Rheumatology
state: Missouri
city: Freehold
country: United States
facility: Arthritis & Osteoporosis Associates, PA
state: New Jersey
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates of New Mexico
state: New Mexico
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dayton
country: United States
facility: STAT Research
state: Ohio
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic, P.A.
state: South Carolina
city: Summerville
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Allen
country: United States
facility: Arthritis & Rheumatology Institute
state: Texas
city: Allen
country: United States
facility: Office of John P. Lavery M.D., PA
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Katy
country: United States
facility: R and H Clinical Research
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research
state: Texas
city: Mesquite
country: United States
facility: SouthWest Rheumatology Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. J. M. Ramos Mejia
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar del Plata
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Policlìnica Red Omip S.A - Ensayos Clinicos GC
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro Dermatologico Schejtman
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: APRILLUS Asistencia e Investigacion
state: Ciudad Autonoma Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes
state: Provincia De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de La Plata
state: Provincia De Buenos Aires
city: Rosario
country: Argentina
facility: Instituto CAICI
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
state: Tucuman
city: San Miguel de Tucumán
country: Argentina
facility: Investigaciones Clinicas Tucuman
state: Tucuman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: STAT Research S.A.
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion (OMI)
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar - Mind Out Research
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Barrio Parque
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Mendoza
country: Argentina
facility: Instituto de Reumatologia
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
city: Barrie
country: Canada
facility: The Waterside Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
state: Hunan
city: ZhuZhou
country: China
facility: ZhuZhou Central Hospital
state: Hunan
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Yanji
country: China
facility: Yanbian University Hospital (Yanbian Hospital)
state: Jilin
city: Jiujiang
country: China
facility: Jiujiang No.1 People's Hospital
state: Jiujiang
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital of Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: The First Affiliated Hospital of Chengdu Medical College
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Barranquilla
country: Colombia
facility: Centro de Investigacion Medico Asistencial S.A.S
city: Barranquilla
country: Colombia
facility: Clínica de la Costa Ltda.
city: Bogotá
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S.
city: Cali
country: Colombia
facility: IPS Centro Medico Julián Coronel S.A.
city: Chia
country: Colombia
facility: Preventive Care Ltda
city: Zipaquirá
country: Colombia
facility: Healthy Medical Center
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Gottingen
country: Germany
facility: Universitaetsmedizin Goettingen
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein Westfalen
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
state: Rheinland Pfalz
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz
city: Szekesfehervar
country: Hungary
facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Kfar- Sava
country: Israel
facility: Meir Medical Center
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Scafati
country: Italy
facility: Ospedale M. Scarlato
state: Salerno
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
city: Padova
country: Italy
facility: Azienda Ospedale-Università di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Università Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
city: Nagoya-shi
country: Japan
facility: JCHO Chukyo Hospital
state: Aichi-Ken
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
state: Aichi-Ken
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba-Ken
city: Chiba-shi
country: Japan
facility: NHO Chibahigashi National Hospital
state: Chiba-Ken
city: Narashino-shi
country: Japan
facility: Chibaken Saiseikai Narashino Hospital
state: Chiba-Ken
city: Fukuoka-shi
country: Japan
facility: KKR Hamanomachi Hospital
state: Fukuoka-Ken
city: Fukuoka-shi
country: Japan
facility: NHO Kyushu Medical Center
state: Fukuoka-Ken
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Fukuoka-Ken
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-Ken
city: Sapporo-shi
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Japanese Red Cross Society Himeji Hospital
state: Hyogo-Ken
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo-Ken
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo-Ken
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa-ken
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa-ken
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa-Ken
city: Yokohama-shi
country: Japan
facility: NHO Yokohama Medical Center
state: Kanagawa-Ken
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto-Ken
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi-Ken
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki-Ken
city: Kawachinagano-shi
country: Japan
facility: NHO Osaka Minami Medical Center
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Tazuke-kofukai Medical Research Institute Kitano Hospital
state: Osaka-Fu
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka-Fu
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka-Fu
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama-Ken
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Hospital
state: Tokyo-To
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo-To
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo-To
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo-To
city: Ota-ku
country: Japan
facility: Toho University Omori Medical Center
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo-To
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
state: Tokyo-To
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico
city: Brasov
country: Romania
facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
city: Bucuresti
country: Romania
facility: S C Delta Health Care SRL
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Iasi
country: Romania
facility: S.C.Centrul Medical Unirea SRL
city: Suceava
country: Romania
facility: Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava
city: Targu Mures
country: Romania
facility: S.C Centrul Medical Unirea SRL
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska kosa
city: Niska Banja
country: Serbia
facility: Institute of Treatment and Rehabilitation 'Niska Banja'
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
state: Greater London
city: London
country: United Kingdom
facility: Guy's Hospital
state: Greater London
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: South Yorkshire
city: Cannock
country: United Kingdom
facility: Cannock Chase Hospital
state: Staffordshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: