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A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus (EMERALD)

Primary Purpose

Systemic Lupus Erythematosus (SLE)

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Litifilimab
Litifilimab-matching placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus (SLE) focused on measuring Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either BIIB059 or placebo to Week 48 and attended the last study assessment visit at Week 52

Key Exclusion Criteria:

  • Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
  • Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period)
  • Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose
  • Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies

NOTE: Other inclusion/exclusion criteria may apply.

Sites / Locations

  • University of Alabama Hospital
  • Arizona Arthritis & Rheumatology Associates, P.C.
  • Wallace Rheumatic Study Center
  • University of California San Diego School of Medicine
  • Valerius Medical Group
  • University of Southern California
  • Providence Facey Medical Foundation
  • Inland Rheumatology Clinical Trials, Inc.
  • Medvin Clinical Research
  • University of Colorado Denver
  • Georgetown University Hospital-Medstar
  • Arthritis & Rheumatic Disease Specialties
  • RASF - Clinical Research Center
  • Clinical Research of West Florida - Corporate
  • Omega Research Consultants
  • Centre for Rheumatology, Immunology and Arthritis
  • University of Florida
  • GNP Research at Mark Jaffe, MD
  • Life Clinical Trials
  • University of Miami Miller School of Medicine
  • Rheumatology Associates of Central Florida
  • Believe Clinical Trials
  • Clinical Research of West Florida, Inc.
  • AdventHealth Medical Group
  • The Emory Clinic Emory University
  • Jefrey Lieberman, M.D., P.C.
  • Arthritis Center of North Georgia
  • Rush University Medical Center
  • Boston University School of Medicine
  • University of Massachusetts
  • AA MRC LLC Ahmed Arif Medical Research Center
  • Washington University, School of Medicine
  • Saint Louis Rheumatology
  • Arthritis & Osteoporosis Associates, PA
  • Arthritis and Osteoporosis Associates of New Mexico
  • NYU Langone Ambulatory Care Brooklyn Heights
  • University of Rochester Medical Center
  • SUNY Upstate Medical Center
  • Joint and Muscle Research Institute
  • DJL Clinical Research, PLLC
  • Medication Management, LLC
  • Carolina Arthritis Associates
  • University of Cincinnati
  • Paramount Medical Research & Consulting, LLC
  • STAT Research
  • Wake Forest University Health Sciences
  • Piedmont Arthritis Clinic, P.A.
  • Low Country Rheumatology, PA
  • West Tennessee Research Institute
  • Ramesh C Gupta, MD
  • Vanderbilt University Medical Center
  • Office of John P. Lavery M.D., PA
  • Tekton Research
  • Precision Comprehensive Clinical Research Solution
  • Precision Comprehensive Clinical Research Solutions
  • Accurate Clinical Research, Inc.
  • Accurate Clinical Research
  • Pioneer Research Solutions, Inc.
  • SouthWest Rheumatology Research, LLC
  • Sun Research Institute, LLC
  • The University of Texas Health Science Center at San Antonio
  • Advanced Rheumatology of Houston
  • CLS Research Ctr, PLLC
  • Swedish Medical Center
  • University of Washington Medical Centre
  • Hospital Italiano de La Plata
  • Centro de Investigaciones Medicas Mar del Plata
  • Investigaciones Clinicas Tucuman
  • Instituto de Investigaciones Clinicas Quilmes
  • Hospital General de Agudos Dr. J. M. Ramos Mejia
  • Centro Dermatologico Schejtman
  • STAT Research S.A.
  • Centro Privado de Medicina Familiar - Mind Out Research
  • Instituto de Reumatologia
  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
  • Centro de Investigaciones Medicas Tucuman
  • Royal Prince Alfred Hospital
  • Box Hill Hospital
  • Footscray Hospital
  • Fiona Stanley Hospital
  • UZ Leuven
  • CHU de Liège
  • Clínica SER da Bahia
  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  • L2IP - Instituto de Pesquisas Clínicas Ltda.
  • CEDOES - Diagnóstico e Pesquisa
  • Oncovida - Centro de Onco-Hematologia de Mato Grosso
  • Santa Casa de Misericórdia de Belo Horizonte
  • CMiP - Centro Mineiro de Pesquisa
  • CETI - Centro de Estudos em Terapias Inovadoras Ltda.
  • LMK Serviços Médicos S/S Ltda
  • Hospital das Clínicas da Faculdade de Medicina da UNICAMP
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
  • MC Artmed OOD
  • UMHAT "Pulmed" OOD
  • UMHAT-Plovdiv AD
  • DCC 1 - Ruse, EOOD
  • DCC "Alexandrovska", EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • Medical Center Hera EOOD
  • Military Medical Academy - MHAT - Sofia
  • UMHAT "Sv. Ivan Rilski", EAD
  • The Waterside Clinic
  • Hamilton Health Sciences Corporation
  • University of Toronto
  • Clinica Alemana de Osorno
  • Centro Medico Prosalud
  • Interin
  • CTR Estudios
  • Enroll Spa
  • BioMedica Research Group
  • SOMEAL
  • Beijing Chaoyang Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • The Third Affiliated Hospital, Sun Yat-sen University
  • Shenzhen People's Hospital
  • Hainan General Hospital
  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
  • Xiangya Hospital, Central South University
  • The 2nd Xiangya Hospital of Central South University
  • ZhuZhou Central Hospital
  • Jiujiang No.1 People's Hospital
  • The Second Affiliated Hospital of Nanchang University
  • Jiangxi Pingxiang People's Hospital
  • The First Hospital of Jilin University
  • Binzhou Medical University Hospital
  • Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine
  • The First Affiliated Hospital of Chengdu Medical College
  • Tianjin Medical University General Hospital
  • People's Hospital of Xinjiang Uighur Autonomous Region
  • Ningbo First Hospital
  • Wenzhou People's Hospital
  • Centro de Investigacion Medico Asistencial S.A.S
  • Clínica de la Costa Ltda.
  • Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
  • Servimed S.A.S.
  • Preventive Care Ltda
  • Healthy Medical Center
  • Fakultni nemocnice Brno
  • Revmatologie s.r.o.
  • Fakultni nemocnice Olomouc
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Hopital Lapeyronie
  • CHU Clermont Ferrand - Hopital Gabriel Montpied
  • Hôpital Cochin
  • Universitaetsmedizin Goettingen
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Koeln
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • General Hospital of Athens Laiko
  • University General Hospital "Attikon"
  • Obudai Egeszsegugyi Centrum Kft.
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
  • Vita Verum Medical Egeszsegugyi Szolgaltato
  • Vital Medical Center
  • Rambam Health Care Center
  • Meir Medical Center
  • Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center Pt
  • Istituto Clinico Humanitas
  • Ospedale M. Scarlato
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Azienda Socio Sanitaria Territoriale Gaetano Pini (Gaetano Pini-CTO)
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera San Camillo Forlanini
  • Università Campus Bio-Medico di Roma
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • JCHO Chukyo Hospital
  • Fujita Health University Hospital
  • NHO Chibahigashi National Hospital
  • Chibaken Saiseikai Narashino Hospital
  • KKR Hamanomachi Hospital
  • NHO Kyushu Medical Center
  • Hospital of the University of Occupational and Environmental Health
  • Hiroshima University Hospital
  • Tonan Hospital
  • Japanese Red Cross Society Himeji Hospital
  • Kobe University Hospital
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital
  • Kagawa University Hospital
  • St. Marianna University Hospital
  • Kitasato University Hospital
  • Yokohama City University Medical Center
  • NHO Yokohama Medical Center
  • Japanese Red Cross Kumamoto Hospital
  • Tohoku University Hospital
  • Nagasaki University Hospital
  • NHO Osaka Minami Medical Center
  • Kitano Hospital
  • Kindai University Hospital
  • Osaka Medical and Pharmaceutical University Hospital
  • Saitama Medical University Hospital
  • Tokyo Medical and Dental University Hospital
  • St. Luke's International Hospital
  • Nihon University Itabashi Hospital
  • Toho University Ohashi Medical Center
  • Toho University Omori Medical Center
  • Keio University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Ajou University Hospital
  • Dong-A University Hospital
  • Gachon University Gil Medical Center
  • Hanyang University Seoul Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • Clinstile, S.A. de C.V.
  • Centro de Investigacion Clínica GRAMEL S.C
  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
  • Diseño y Planeacion en Investigacion Medica S.C.
  • Clinica de Investigacion en Reumatologia y Obesidad S.C.
  • Consultorio Particular del Dr. Miguel Cortes Hernandez
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Centro Peninsular de Investigacion Clinica, SCP
  • Medical Care & Research SA de CV
  • Investigacion y Biomedicina de Chihuahua, S.C.
  • Centro de Investigacion y Atencion Integral Durango CIAID
  • Amsterdam UMC, Locatie VUMC
  • Universitair Medisch Centrum Groningen
  • Maastricht University Medical Center
  • UMC Utrecht
  • Hogar Clínica San Juan de Dios - Arequipa
  • Hospital Nacional Edgardo Rebagliati Martins
  • HMA - Hospital Maria Auxiliadora
  • Clinica San Felipe - Centro de Investigacion Clinica Inmunoreumatologia
  • Davao Doctors Hospital
  • Mary Mediatrix Medical Center
  • Medical Center Manila
  • Philippine General Hospital
  • The Medical City Clark
  • Manila Doctors Hospital
  • University of Santo Tomas
  • St. Luke's Medical Center
  • Far Eastern University - Dr. Nicanor Reyes Medical Foundation
  • Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
  • Szpital Uniwersytecki nr 2 im.dr J. Biziela
  • Centrum Medyczne Intercor Sp. z o.o
  • Nzoz Bif-Med
  • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
  • Centrum Medyczne All-Med
  • Pratia MCM Krakow
  • Centrum Medyczne Plejady
  • Reumed Spolka z o.o.
  • SP Szpital Kliniczny nr 1 PUM im. prof. Tadeusza Sokolowskiego
  • MICS Centrum Medyczne Warszawa
  • Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
  • Centro Reumatologico
  • S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
  • S C Delta Health Care SRL
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca
  • S.C.Centrul Medical Unirea SRL
  • S.C Centrul Medical Unirea SRL
  • LLC "Medical Center" Revma-Med "
  • Olla-Med, Llc
  • V.A. Nasonova Research Rheumatology Institute
  • SBIH "Orenburg Regional Clinical Hospital"
  • SPb SBIH "Clinical Rheumatological Hospital # 25"
  • Clinical Hospital Center "Bezanijska kosa"
  • Institute of Rheumatology
  • University Clinical Center of Serbia
  • Institute of Treatment and Rehabilitation "Niska Banja"
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario San Cecilio
  • Hospital Universitario Virgen Macarena
  • Hospital Quironsalud Infanta Luisa
  • Hospital Universitario Dr. Peset
  • Skåne University Hospital
  • Karolinska Universitetssjukhuset Solna
  • Akademiska Sjukhuset
  • Universitetssjukhuset Orebro
  • Kaohsiung Chang Gung Memorial Hospital
  • Chang Gung Memorial Hospital,Linkou
  • Whipps Cross University Hospital
  • St Thomas' Hospital
  • Doncaster Royal Infirmary
  • Cannock Chase Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Litifilimab Low Dose

Litifilimab High Dose

Arm Description

Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.

Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.

Outcomes

Primary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.
Number of Participants with Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.

Secondary Outcome Measures

Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
SRI-4 is a composite endpoint defined as the following: A reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score. No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit. No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) visual analog scale (VAS). No violation of protocol-specified medication rules
Percentage of Participants who Achieved a Joint-50 Response
Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response
CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A. CLASI-70 is 70% of improvement from baseline in CLASI-A and CLASI-90 is 90% of improvement from baseline in CLASI-A.
Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
BICLA is a composite endpoint defined as the following: BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at Baseline improved to B, C, or D and all of BILAG-2004 Grade B at Baseline improved to C or D. No BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 Grade A or greater than 1 new BILAG-2004 Grade B. No worsening in the SLEDAI-2K total score compared to baseline. No worsening from baseline in lupus disease activity defined by a <0.3-point increase on a 3-point PGA VAS. No violation of protocol-specified medication rules.
Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
A severe flare is defined as any of the following: Change in SLEDAI instrument score to >12 New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000/mL, or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose, increase to >0.5 milligrams per kilograms per day (mg/kg/day) or hospitalization Increase in prednisone dose to >0.5 mg/kg/day New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity Hospitalization for SLE activity Increase in PGA score to >2.5
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Percentage of Participants With Sustained LLDAS
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score
SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage.
Cumulative Exposure to OCS Over Time
Percentage of Participants With OCS ≤7.5 mg
Percentage of Participants With OCS ≤5 mg
Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health).
Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.
Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity.
Change from Baseline in Patient Global Assessment (PtGA) Score
The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question.
Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.
Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
Number of Participants with Antibodies to Litifilimab

Full Information

First Posted
April 25, 2022
Last Updated
September 13, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT05352919
Brief Title
A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus
Acronym
EMERALD
Official Title
A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
March 13, 2029 (Anticipated)
Study Completion Date
March 13, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.
Detailed Description
This is an extension study for all participants who completed study 230LE303 (NCT04895241) and 230LE304 (NCT04961567) (parent phase 3 studies) through Week 52 and did not discontinue litifilimab or placebo. Eligible participants from parent phase 3 studies will be followed for up to 180 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus (SLE)
Keywords
Lupus Erythematosus, Systemic Autoimmune Diseases, Connective Tissue Diseases, Immune System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
864 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Litifilimab Low Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus standard of care (SOC) therapy and received litifilimab low dose, subcutaneously (SC), every 4 weeks (Q4W) during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab low dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.
Arm Title
Litifilimab High Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab high dose, SC, Q4W during the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will continue to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose of litifilimab-matching placebo at Week 2. Participants who are receiving background nonbiologic lupus SOC therapy and received litifilimab-matching placebo in the parent Phase 3 studies (i.e. studies 230LE303 [NCT04895241] or 230LE304 [NCT04961567]) will be randomized to receive litifilimab high dose, SC, Q4W from Day 1 up to 152 weeks with an additional dose at Week 2.
Intervention Type
Drug
Intervention Name(s)
Litifilimab
Other Intervention Name(s)
BIIB059
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Litifilimab-matching placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that started or worsened in severity after the first dose of study treatment through 28 days after the last dose of study treatment or end of study (EOS) date, whichever comes earlier.
Time Frame
Up to Week 180
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
An SAE is any untoward medical occurrence that at any dose results in death, in the view of the Investigator, places the participant at immediate risk of death (a life threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, and is a medically important event.
Time Frame
Up to Week 180
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieved an Systemic Lupus Erythematosus Responder Index (SRI)-4 Response
Description
SRI-4 is a composite endpoint defined as the following: A reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score. No new organ system affected, as defined by no new British Isles Lupus Activity Group-2004 (BILAG-2004 grade A) and no more than 1 new BILAG 2004 grade B versus previous visit. No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point Physician's Global Assessment (PGA) visual analog scale (VAS). No violation of protocol-specified medication rules
Time Frame
Up to Week 180
Title
Percentage of Participants who Achieved a Joint-50 Response
Description
Joint-50 response is a 50% reduction in total active joint count from baseline. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). A 28-joint assessment will be performed to determine the active joint count, which is defined as the sum of tender and swollen joint counts.
Time Frame
Up to Week 180
Title
Percentage of Participants who Achieved Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-50, CLASI-70, and CLASI-90 Response
Description
CLASI score is used to evaluate lupus skin manifestations. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Scores for each area are assigned based on the most severe lesion within the area of interest. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-50 is 50% of improvement from baseline in CLASI-A. CLASI-70 is 70% of improvement from baseline in CLASI-A and CLASI-90 is 90% of improvement from baseline in CLASI-A.
Time Frame
Up to Week 180
Title
Percentage of Participants who Achieved a British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) Response
Description
BICLA is a composite endpoint defined as the following: BILAG-2004 improvement, defined as all of BILAG-2004 Grade A at Baseline improved to B, C, or D and all of BILAG-2004 Grade B at Baseline improved to C or D. No BILAG-2004 worsening in other BILAG-2004 organ systems such that there are no new BILAG-2004 Grade A or greater than 1 new BILAG-2004 Grade B. No worsening in the SLEDAI-2K total score compared to baseline. No worsening from baseline in lupus disease activity defined by a <0.3-point increase on a 3-point PGA VAS. No violation of protocol-specified medication rules.
Time Frame
Up to Week 180
Title
Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index Flare Index (SFI) Flare Rate
Description
A severe flare is defined as any of the following: Change in SLEDAI instrument score to >12 New or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000/mL, or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose, increase to >0.5 milligrams per kilograms per day (mg/kg/day) or hospitalization Increase in prednisone dose to >0.5 mg/kg/day New requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity Hospitalization for SLE activity Increase in PGA score to >2.5
Time Frame
Up to Week 156
Title
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Description
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Time Frame
Up to Week 180
Title
Percentage of Participants With Sustained LLDAS
Description
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Time Frame
Up to Week 180
Title
Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS
Description
LLDAS is a composite endpoint defined as the following: i. SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and ii. No new features of lupus disease activity compared with the previous assessment; and iii. SELENA-SLEDAI PGA ≤ 1; and iv. Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and v. Standard maintenance doses of immunosuppressive drugs and approved biological agents. "No new features" is defined as any new SLEDAI-2K component that was not present at the previous assessment. The SELENA-SLEDAI PGA Scale ranges from 0-3, where 0 is no disease activity and 3 is maximum disease activity. "Standard maintenance doses" include drugs limited to those allowed per protocol.
Time Frame
Up to Week 180
Title
Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) Score
Description
SDI score is used to assess the accumulated damage in participants with SLE. It assess 12 organ systems and records damage in participants with lupus, regardless of its cause. Damage could be due to previous disease activity, medication, or intercurrent illness (such as surgery or cancer). To distinguish between active inflammation and damage, an item must be present for at least 6 months. It is assumed that persistent inflammation (for at least 6 months) would result in tissue injury and hence damage. SDI is evaluated on a scale 0-47 with higher score indicating higher damage.
Time Frame
Up to Week 156
Title
Cumulative Exposure to OCS Over Time
Time Frame
Up to Week 156
Title
Percentage of Participants With OCS ≤7.5 mg
Time Frame
Up to Week 156
Title
Percentage of Participants With OCS ≤5 mg
Time Frame
Up to Week 156
Title
Change From Baseline in Lupus-Specific Health-Related Quality-Of-Life (LupusQoL) Score
Description
The LupusQoL is a participant-reported, lupus-specific, HRQoL questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all the time. A LupusQoL score for each domain will be reported on a 0 to 100 scale, with greater values indicating better HRQoL.
Time Frame
Up to Week 156
Title
Change From Baseline in Short Form Health Survey-36 (SF-36) (Acute Version) Score
Description
The SF-36 is a 36-item scale which assesses HRQoL in 8 domains: limitations in physical activities due to health problems, limitations in social activities due to physical or emotional problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to emotional problems, vitality (energy and fatigue), general health perceptions. The SF-36 (Acute Version) form asks for participants to reply to questions (items) according to how they have felt over a specifically defined period of time. Items 1-4 primarily contribute to the physical component summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36 where higher scores indicate best health. Scores on each item are summed and averaged (range: 0=worse health to 100=best possible health).
Time Frame
Up to Week 156
Title
Change From Baseline in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
Description
The EQ-5D is a standardized generic measure of health status developed by the European Quality of Life Group. This study uses the EQ-5D-3L version of the instrument. This instrument consists of 2 sections. The first section comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. All dimensions are measured on a 3-point scale, 1: No problems; 2: Some problems; 3: Extreme problems. The second section comprises the Visual Analogue Scale, which records the respondent's self-rated health on a vertical scale ranging from 0 to 100, lower scores indicate the worst possible health state.
Time Frame
Up to Week 156
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
Description
The FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in 5 broad categories: physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns. The level of fatigue is measured by questions assessed on a 5-point scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The responses for each item are added to obtain a total score which ranges from 0 to 52, with a higher score indicating less fatigue.
Time Frame
Up to Week 156
Title
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Description
The PHQ-9 is a participant-administered HRQoL questionnaire to screen for the presence and severity of depression. The PHQ-9 is a participant-reported outcome (PRO) that is used to measure depression in adults. It contains 9 questions, with a 2 week recall period. The PHQ-9 yields an overall severity score that can range from 0 to 27 with the following severity scores: 0-4 = none; 5-9 = mild; 10-14 = moderate; 15-19 = moderate-to-severe; and 20-27 = severe.
Time Frame
Up to Week 156
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI):Lupus Score
Description
WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. Each score ranges from 0 to 100, with higher numbers indicating greater impairment and less productivity.
Time Frame
Up to Week 156
Title
Change from Baseline in Patient Global Assessment (PtGA) Score
Description
The PtGA is participant-administered, single-item question evaluating the impact of health and illness, with responses ranging from very poor to very well on a 100 mm VAS. The participant will consider the previous week when addressing this question.
Time Frame
Up to Week 156
Title
Number of Participants with Clinically Relevant Abnormalities in Standard Laboratory Parameters
Description
Standard laboratory parameters will include hematology, blood chemistry, urinalysis, and coagulation.
Time Frame
Up to Week 180
Title
Number of Participants with Clinically Relevant Abnormalities in Electrocardiogram (ECG) Results
Time Frame
Up to Week 156
Title
Number of Participants with Antibodies to Litifilimab
Time Frame
Up to Week 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) on study treatments with either litifilimab or placebo to Week 48 and attended the last study assessment visit at Week 52 Key Exclusion Criteria: Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52) Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52 week treatment period) Participants who developed moderate-to-severe worsening of organ-specific lupus manifestations that would require a change in antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose) Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies NOTE: Other inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
University of California San Diego School of Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-094
Country
United States
Facility Name
Valerius Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5403
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Providence Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Hospital-Medstar
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
RASF - Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Clinical Research of West Florida - Corporate
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
GNP Research at Mark Jaffe, MD
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Life Clinical Trials
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Believe Clinical Trials
City
Ruskin
State/Province
Florida
ZIP/Postal Code
33573-6801
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
AdventHealth Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
The Emory Clinic Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Jefrey Lieberman, M.D., P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
AA MRC LLC Ahmed Arif Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Washington University, School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint Louis Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Arthritis & Osteoporosis Associates, PA
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629-1986
Country
United States
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Joint and Muscle Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Paramount Medical Research & Consulting, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
STAT Research
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Piedmont Arthritis Clinic, P.A.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Ramesh C Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0028
Country
United States
Facility Name
Office of John P. Lavery M.D., PA
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solution
City
Colleyville
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Accurate Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77095
Country
United States
Facility Name
SouthWest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Sun Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
CLS Research Ctr, PLLC
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Centre
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000ICL
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Hospital General de Agudos Dr. J. M. Ramos Mejia
City
Buenos Aires
ZIP/Postal Code
C1430
Country
Argentina
Facility Name
Centro Dermatologico Schejtman
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
STAT Research S.A.
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1013AAB
Country
Argentina
Facility Name
Centro Privado de Medicina Familiar - Mind Out Research
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Facility Name
Instituto de Reumatologia
City
Mendoza
ZIP/Postal Code
M5500
Country
Argentina
Facility Name
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Centro de Investigaciones Medicas Tucuman
City
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Box Hill Hospital
City
Caulfield
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clínica SER da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150-150
Country
Brazil
Facility Name
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-275
Country
Brazil
Facility Name
L2IP - Instituto de Pesquisas Clínicas Ltda.
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-740
Country
Brazil
Facility Name
CEDOES - Diagnóstico e Pesquisa
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Oncovida - Centro de Onco-Hematologia de Mato Grosso
City
Cuiabá
State/Province
Mato Grosso
ZIP/Postal Code
78040-360
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
CETI - Centro de Estudos em Terapias Inovadoras Ltda.
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
LMK Serviços Médicos S/S Ltda
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da UNICAMP
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-881
Country
Brazil
Facility Name
Centro Multidisciplinar de Estudos Clínicos - CEMEC
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09190-510
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
MC Artmed OOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT "Pulmed" OOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT-Plovdiv AD
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
DCC 1 - Ruse, EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
DCC "Alexandrovska", EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Military Medical Academy - MHAT - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
The Waterside Clinic
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Clinica Alemana de Osorno
City
Osorno
ZIP/Postal Code
1530 531
Country
Chile
Facility Name
Centro Medico Prosalud
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Facility Name
Interin
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Facility Name
CTR Estudios
City
Santiago
ZIP/Postal Code
7500571
Country
Chile
Facility Name
Enroll Spa
City
Santiago
ZIP/Postal Code
7500588
Country
Chile
Facility Name
BioMedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
SOMEAL
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The 2nd Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
ZhuZhou Central Hospital
City
ZhuZhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Facility Name
Jiujiang No.1 People's Hospital
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
ZIP/Postal Code
256603
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The First Affiliated Hospital of Chengdu Medical College
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610500
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
People's Hospital of Xinjiang Uighur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Wenzhou People's Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Centro de Investigacion Medico Asistencial S.A.S
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Clínica de la Costa Ltda.
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Servimed S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Preventive Care Ltda
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Healthy Medical Center
City
Zipaquirá
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33706
Country
France
Facility Name
Hopital Lapeyronie
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Clermont Ferrand - Hopital Gabriel Montpied
City
Clermont-Ferrand cedex 1
State/Province
Puy De Dome
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Universitaetsmedizin Goettingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
General Hospital of Athens Laiko
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital "Attikon"
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Vita Verum Medical Egeszsegugyi Szolgaltato
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Meir Medical Center
City
Kfar- Sava
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265602
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Pt
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale M. Scarlato
City
Scafati
State/Province
Salerno
ZIP/Postal Code
84018
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Gaetano Pini (Gaetano Pini-CTO)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00151
Country
Italy
Facility Name
Università Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00155
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
JCHO Chukyo Hospital
City
Nagoya-shi
State/Province
Aichi-Ken
ZIP/Postal Code
457-8510
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake-shi
State/Province
Aichi-Ken
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
NHO Chibahigashi National Hospital
City
Chiba-shi
State/Province
Chiba-Ken
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Chibaken Saiseikai Narashino Hospital
City
Narashino-shi
State/Province
Chiba-Ken
ZIP/Postal Code
275-8580
Country
Japan
Facility Name
KKR Hamanomachi Hospital
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
NHO Kyushu Medical Center
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health
City
Kitakyushu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
State/Province
Hiroshima-Ken
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Tonan Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0004
Country
Japan
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Himeji-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
670-8540
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe-shi
State/Province
Hyogo-Ken
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Kobe City Hospital Organization Kobe City Medical Center General Hospital
City
Kobe-shi
State/Province
Hyogo-ken
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa-Ken
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
St. Marianna University Hospital
City
Kawasaki-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
NHO Yokohama Medical Center
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto-Ken
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-shi
State/Province
Miyagi-Ken
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki-Ken
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
NHO Osaka Minami Medical Center
City
Kawachi-Nagano
State/Province
Osaka-Fu
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Kitano Hospital
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
530-8480
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka-Fu
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki-shi
State/Province
Osaka-Fu
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
State/Province
Saitama-Ken
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
St. Luke's International Hospital
City
Chuo-ku
State/Province
Tokyo-To
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo-To
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
State/Province
Tokyo-To
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Ota-ku
State/Province
Tokyo-To
ZIP/Postal Code
143-8541
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinstile, S.A. de C.V.
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Centro de Investigacion Clínica GRAMEL S.C
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03720
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Diseño y Planeacion en Investigacion Medica S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S.C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Consultorio Particular del Dr. Miguel Cortes Hernandez
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro Peninsular de Investigacion Clinica, SCP
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Medical Care & Research SA de CV
City
Yucatan
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua, S.C.
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Centro de Investigacion y Atencion Integral Durango CIAID
City
Durango
ZIP/Postal Code
34080
Country
Mexico
Facility Name
Amsterdam UMC, Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Hogar Clínica San Juan de Dios - Arequipa
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Facility Name
Hospital Nacional Edgardo Rebagliati Martins
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
HMA - Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Facility Name
Clinica San Felipe - Centro de Investigacion Clinica Inmunoreumatologia
City
Lima
ZIP/Postal Code
Lima 31
Country
Peru
Facility Name
Davao Doctors Hospital
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Mary Mediatrix Medical Center
City
Lipa City
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Medical Center Manila
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
The Medical City Clark
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1004
Country
Philippines
Facility Name
University of Santo Tomas
City
Manila
ZIP/Postal Code
1015
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Facility Name
Far Eastern University - Dr. Nicanor Reyes Medical Foundation
City
Quezon City
ZIP/Postal Code
1118
Country
Philippines
Facility Name
Nova Reuma Domysławska i Rusiłowicz, Spółka Partnerska Lekarza Reumatologa i Fizjoterapeuty
City
Bialystok
ZIP/Postal Code
15-707
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im.dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Medyczne Intercor Sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-312
Country
Poland
Facility Name
Nzoz Bif-Med
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Medyczne All-Med
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Reumed Spolka z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
SP Szpital Kliniczny nr 1 PUM im. prof. Tadeusza Sokolowskiego
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
ZIP/Postal Code
00-660
Country
Poland
Facility Name
Niepubliczny Zakład Opieki Zdrowotnej "Biogenes" Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Centro Reumatologico
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
S C Delta Health Care SRL
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
S.C.Centrul Medical Unirea SRL
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
S.C Centrul Medical Unirea SRL
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
LLC "Medical Center" Revma-Med "
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Facility Name
Olla-Med, Llc
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
V.A. Nasonova Research Rheumatology Institute
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
SBIH "Orenburg Regional Clinical Hospital"
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
SPb SBIH "Clinical Rheumatological Hospital # 25"
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Clinical Hospital Center "Bezanijska kosa"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Treatment and Rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41089
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Universitetssjukhuset Orebro
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital,Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Whipps Cross University Hospital
City
Leytonstone
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
St Thomas' Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Cannock Chase Hospital
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

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