Back to resultsA Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care (TOPAZ-2)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BIIB059 (litifilimab)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Lupus, SLE, CLE
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:
- Antimalarials as stand-alone treatment
- Antimalarial treatment in combination with OCS and/or immunosuppressants
- Treatment with OCS and/or immunosuppressants.
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 hepatitis B surface antigen [HBsAg] and/or total hepatitis B core antibody [anti-HBc]).
- 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.
Sites / Locations
- University of Alabama Birmingham
- Arizona Arthritis & Rheumatology Associates, P.C.Recruiting
- Valerius Medical GroupRecruiting
- Kotha
- RASF - Clinical Research CenterRecruiting
- University of Florida GainesvilleRecruiting
- University of Miami Miller School of MedicineRecruiting
- Clinical Research of West Florida, Inc.Recruiting
- The Emory Clinic Emory UniversityRecruiting
- Arthritis Center of North GeorgiaRecruiting
- Rush University Medical Center
- LSU Health Sciences Center
- Boston University School of MedicineRecruiting
- University of MassachusettsRecruiting
- Saint Louis RheumatologyRecruiting
- Arthritis & Osteoporosis Associates, PARecruiting
- Arthritis and Osteoporosis Associates of New MexicoRecruiting
- DJL Clinical Research, PLLCRecruiting
- Carolina Arthritis AssociatesRecruiting
- University of CincinnatiRecruiting
- STAT ResearchRecruiting
- Piedmont Arthritis Clinic, P.A.Recruiting
- Low Country Rheumatology, PARecruiting
- West Tennessee Research InstituteRecruiting
- Office of John P. Lavery M.D., PARecruiting
- Tekton ResearchRecruiting
- Precision Comprehensive Clinical Research SolutionsRecruiting
- The University of Texas Health
- SouthWest Rheumatology Research, LLCRecruiting
- Sun Research Institute, LLCRecruiting
- Swedish Medical CenterRecruiting
- Hospital General de Agudos Dr. J. M. Ramos MejiaRecruiting
- Centro Privado de Medicina Familiar - Mind Out ResearchRecruiting
- APRILLUS Asistencia e Investigacion
- CINME - Centro De Investigaciones Metabolicas
- Hospital Italiano de La PlataRecruiting
- Hospital Italiano de La PlataRecruiting
- Centro de Investigaciones Medicas Mar del PlataRecruiting
- Instituto de Investigaciones Clinicas QuilmesRecruiting
- Centro Dermatologico SchejtmanRecruiting
- Centro de Investigaciones Medicas TucumanRecruiting
- Investigaciones Clinicas TucumanRecruiting
- Investigaciones Clinicas TucumanRecruiting
- STAT Research S.A.Recruiting
- Centro Privado de Medicina Familiar - Mind Out ResearchRecruiting
- Instituto de ReumatologiaRecruiting
- CER San Juan Centro Polivalente de Asistencia e Inv. ClinicaRecruiting
- UZ LeuvenRecruiting
- CHU de LiègeRecruiting
- The Waterside ClinicRecruiting
- Hamilton Health Sciences Corporation
- University of Toronto
- Shenzhen People's HospitalRecruiting
- Hainan General HospitalRecruiting
- EC of Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
- Xiangya Hospital, Central South UniversityRecruiting
- The 2nd Xiangya Hospital of Central South UniversityRecruiting
- ZhuZhou Central HospitalRecruiting
- The Second Affiliated Hospital of Nanchang UniversityRecruiting
- Jiangxi Pingxiang People's HospitalRecruiting
- The First Hospital of Jilin University
- Jiujiang No.1 People's HospitalRecruiting
- Binzhou Medical University HospitalRecruiting
- Renji Hospital Shanghai Jiaotong University School of Medicine - West BranchRecruiting
- Ruijin Hospital of Shanghai Jiaotong University School of MedicineRecruiting
- The First Affiliated Hospital of Chengdu Medical CollegeRecruiting
- Tianjin Medical University General HospitalRecruiting
- People's Hospital of Xinjiang Uighur Autonomous Region
- The First Affiliated Hospital of Ningbo UniversityRecruiting
- Wenzhou People's HospitalRecruiting
- Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
- Peking Union Medical College HospitalRecruiting
- The Third Affiliated Hospital, Sun Yat-sen University
- Centro de Investigacion Medico Asistencial S.A.SRecruiting
- Clínica de la Costa Ltda.Recruiting
- Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.Recruiting
- Servimed S.A.S.Recruiting
- IPS Centro Medico Julián Coronel S.A.
- Preventive Care LtdaRecruiting
- Fundacion Centro de Investigaciones Clinica Ips Cardiomet Pereira
- Healthy Medical CenterRecruiting
- Fakultni nemocnice Brno
- Revmatologie s.r.o.Recruiting
- Fakultni nemocnice OlomoucRecruiting
- ARTHROHELP s.r.o.
- Universitaetsmedizin GoettingenRecruiting
- Medizinische Hochschule HannoverRecruiting
- Universitaetsklinikum KoelnRecruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet MainzRecruiting
- Obudai Egeszsegugyi Centrum Kft.
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai IntezetRecruiting
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai IntezetRecruiting
- Egyesitett Szt. Istvan
- Bekes Varmegyei Kozponti KorhazRecruiting
- Vita Verum Medical Egeszsegugyi Szolgaltato Bt.Recruiting
- Vital Medical CenterRecruiting
- Rambam Health Care CenterRecruiting
- Meir Medical CenterRecruiting
- Rabin Medical Center-Beilinson CampusRecruiting
- Chaim Sheba Medical CenterRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- Research Site
- Azienda Ospedaliera San Camillo ForlaniniRecruiting
- Ospedale M. ScarlatoRecruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)Recruiting
- Azienda Socio Sanitaria Territ
- Azienda Ospedaliera di PadovaRecruiting
- Azienda Ospedaliero Universitaria PisanaRecruiting
- Università Campus Bio-Medico di RomaRecruiting
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La SapienzaRecruiting
- Tokyo Medical and Dental University HospitalRecruiting
- NHO Chibahigashi National HospitalRecruiting
- St. Luke's International HospitalRecruiting
- KKR Hamanomachi HospitalRecruiting
- NHO Kyushu Medical CenterRecruiting
- Japanese Red Cross Society Himeji HospitalRecruiting
- Hiroshima University HospitalRecruiting
- Saitama Medical University HospitalRecruiting
- Nihon University Itabashi HospitalRecruiting
- NHO Osaka Minami Medical CenterRecruiting
- St. Mariana University HospitalRecruiting
- Kagawa University HospitalRecruiting
- Hospital of the University of Occupational and Environmental Health, JapanRecruiting
- Kobe University HospitalRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Japanese Red Cross Kumamoto HospitalRecruiting
- Toho University Ohashi Medical CenterRecruiting
- Nagasaki University HospitalRecruiting
- JCHO Chukyo HospitalRecruiting
- Chibaken Saiseikai Narashino HospitalRecruiting
- Kindai University HospitalRecruiting
- Kitano HospitalRecruiting
- Toho University Omori Medical CenterRecruiting
- Kitasato University HospitalRecruiting
- Tonan HospitalRecruiting
- Tohoku University HospitalRecruiting
- National Center for Global Health and MedicineRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Keio University HospitalRecruiting
- Fujita Health University HospitalRecruiting
- NHO Yokohama Medical CenterRecruiting
- Yokohama City University CenterRecruiting
- Amsterdam UMC, Locatie VUMCRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Maastricht Univ Med Centre
- UMC UtrechtRecruiting
- Centro ReumatologicoRecruiting
- S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.LRecruiting
- S.C Dental Health Care SRLRecruiting
- Spitalul Clinic Judetean de Urgenta Cluj NapocaRecruiting
- S.C.Centrul Medical Unirea SRLRecruiting
- Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
- S.C Centrul Medical Unirea SRLRecruiting
- Institute of RheumatologyRecruiting
- Institute of RheumatologyRecruiting
- University Clinical Center of SerbiaRecruiting
- University Clinical Center of SerbiaRecruiting
- Clinical Hospital Center Bezanijska kosaRecruiting
- Institute of Treatment and Rehabilitation "Niska Banja"Recruiting
- Whipps Cross University HospitalRecruiting
- Guy's HospitalRecruiting
- Doncaster Royal InfirmaryRecruiting
- Cannock Chase HospitalRecruiting
- Royal Infirmary of Edinburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BIIB059 High Dose
BIIB059 Low Dose
Placebo
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of BIIB059, SC Q4W, up to Week 48 with an additional dose at Week 2.
Participants who are receiving background nonbiologic lupus SOC therapy will receive BIIB059 matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
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 to protocol-specified medication rules.
Secondary Outcome Measures
Percentage of Participants Who Achieved an SRI-4 Response at Week 24
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules.
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Joint-50 response is 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 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
No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52.
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
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. 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 form baseline in CLASI-A.
Annualized Flare Rate Through Week 52
Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25.
Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit
The PGA is an investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. PGA asks the investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE.
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade 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 with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules.
Time to Onset of SRI-4 Response Sustained Through Week 52
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules.
Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules. SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.
Percentage of Participants with Joint-50 Response by Visit
Joint-50 response is 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 with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively.
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A ≤1 represent the absolute score ≤1 in CLASI-A by visit.
Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done.
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)
SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or 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:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
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
LLDAS is a composite endpoint defined as:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Percentage of Participants who Achieved LLDAS at Week 52
LLDAS is a composite endpoint defined as:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
The LupusQoL is a participant-reported, lupus-specific, health-related quality-of-life questionnaire (HRQoL) 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) Score
SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 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
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. 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. Presenteeism (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 scores indicating greater impairment and less productivity.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event.
Number of Participants with Antibodies to BIIB059
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961567
Brief Title
A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Acronym
TOPAZ-2
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
September 18, 2025 (Anticipated)
Study Completion Date
March 5, 2026 (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 demonstrate efficacy of BIIB059 (litifilimab) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity.
The secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid(s) (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE and to evaluate immunogenicity of BIIB059 in participants with active SLE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Lupus, SLE, CLE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BIIB059 High Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive high dose of BIIB059, subcutaneously (SC), every 4 weeks (Q4W), up to Week 48 with an additional dose at Week 2.
Arm Title
BIIB059 Low Dose
Arm Type
Experimental
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive low dose of BIIB059, SC Q4W, up to Week 48 with an additional dose at Week 2.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who are receiving background nonbiologic lupus SOC therapy will receive BIIB059 matching placebo, SC Q4W, up to Week 48 with an additional dose at Week 2.
Intervention Type
Drug
Intervention Name(s)
BIIB059 (litifilimab)
Other Intervention Name(s)
litifilimab
Intervention Description
Administered as specified in the treatment arm.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Systemic Lupus Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
Description
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
No new organ system affected as defined by no new organ system with British Isles Lupus Assessment Group-2004 (BILAG-2004) grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
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 to protocol-specified medication rules.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an SRI-4 Response at Week 24
Description
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules.
Time Frame
Week 24
Title
Percentage of Participants With at Least 4 Joints (Both Swollen and Tender) at Baseline Who Achieved a Joint-50 Response at Week 52
Description
Joint-50 response is 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
Week 52
Title
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
Description
No worsening of the disease is defined as no new BILAG-2004 grade A or less than 2 new BILAG-2004 grade B since the last visit during the Week 40 to Week 52.
Time Frame
Week 40 up to Week 52
Title
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
Description
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. 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 form baseline in CLASI-A.
Time Frame
Week 16
Title
Annualized Flare Rate Through Week 52
Description
Annualized flare rate will be calculated as the total number of flares divided by the flare exposure time in days, and the ratio multiplied by 365.25.
Time Frame
Up to Week 52
Title
Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog Scale (VAS) Score by Visit
Description
The PGA is an investigator-administered assessment used to quantify disease activity and is measured using an anchored VAS. PGA asks the investigator to assess the participant's current disease activity from a score of 0 (none) to 3 (severe), with the assessment made relative to the most severe state of SLE.
Time Frame
Up to Week 52
Title
Percentage of Participants Who Achieved a British Isles Lupus Activity Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
Description
The BILAG disease activity index evaluates SLE activity in number of organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows, BILAG A: severe disease activity; BILAG B: moderate disease activity; BILAG C: Stable mild disease; BILAG D: System previously affected but now inactive; BILAG E: System never involved. BICLA is a composite endpoint defined as BILAG-2004 improvement, defined as all BILAG-2004 grade A at Baseline improved to grade B, C, or D, and all BILAG-2004 grade B at baseline improved to grade 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 with Baseline, no worsening from Baseline in lupus disease activity defined by < 0.3-point increase on 3-point PGA-VAS and no violation to protocol-specified medication rules.
Time Frame
Up to Week 52
Title
Time to Onset of SRI-4 Response Sustained Through Week 52
Description
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules.
Time Frame
Up to Week 52
Title
Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
Description
An SRI-4 response is a composite endpoint defined by the following criteria:
Reduction from baseline of ≥4 points in SLEDAI-2K.
No new organ system affected as defined by no new organ system with BILAG-2004 grade A and no more than 1 new organ system with BILAG-2004 grade B compared with baseline.
No worsening from baseline in lupus disease activity as defined by <0.3-point increase on 3-point PGA-VAS.
No violation to protocol-specified medication rules. SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.
Time Frame
Up to Week 52
Title
Percentage of Participants with Joint-50 Response by Visit
Description
Joint-50 response is 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 52
Title
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-20, -50, -70, or -90 Response by Visit
Description
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-20, -50, -70 and -90 represent 20%, 50%, 70% or 90% improvement from baseline in CLASI-A score, respectively.
Time Frame
Up to Week 52
Title
Percentage of Participants with Baseline CLASI-A Score ≥10 Who Achieved a CLASI-A Score of ≤1 by Visit
Description
Cutaneous Lupus Erythematosus Disease Area and Severity Index - Activity (CLASI-A) score is used to evaluate lupus skin manifestations. CLASI-A scores of 0 to 9, 10 to 20, and 21 to 70 represent disease severity of mild, moderate, and severe, respectively. CLASI-A ≤1 represent the absolute score ≤1 in CLASI-A by visit.
Time Frame
Up to Week 52
Title
Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe Flare by Visit
Description
BILAG-2004 severe flare is defined as an A score for items recorded as worse or new. BILAG-2004 is evaluated by scoring each item of a list of signs and symptoms given as 4 = new; 3 = worse; 2 = same; 1 = improving; 0 = not present; and ND = not done.
Time Frame
Up to Week 52
Title
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)
Description
SFI severe flare is defined any of the following: change in SLEDAI instrument score to >12; or new or worse: central nervous system SLE; vasculitis; nephritis; myositis; platelets <60,000 per milliliter (/mL); or hemolytic anemia with hemoglobin <7 grams per deciliter (g/dL) or decrease in hemoglobin >3 g/dL and requiring: doubling prednisone dose; or increase to >0.5 milligrams per kilogram per day (mg/kg/day) or hospitalization; or increase in prednisone dose to >0.5 mg/kg/day; or new requirement for cyclophosphamide, azathioprine, methotrexate, or mycophenolate for SLE activity; or hospitalization for SLE activity; or increase in PGA score to >2.5.
Time Frame
Up to Week 52
Title
Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
Description
LLDAS is a composite endpoint defined as:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Time Frame
Up to Week 52
Title
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
Description
LLDAS is a composite endpoint defined as:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Time Frame
Up to Week 52
Title
Percentage of Participants who Achieved LLDAS at Week 52
Description
LLDAS is a composite endpoint defined as:
SLEDAI-2K score ≤ 4, with no activity in a major organ system (renal, central nervous system, cardiopulmonary, vasculitis, fever); and
No new features of lupus disease activity compared with the previous assessment; and
SELENA-SLEDAI PGA ≤ 1; and
Current prednisone (or equivalent) dose ≤ 7.5 mg/day; and
Standard maintenance doses of immunosuppressive drugs and approved biological agents.
Time Frame
Week 52
Title
Percentage of Participants With Baseline OCS ≥10 mg/day Who Achieved ≤7.5 mg/day at Week 52
Time Frame
Week 52
Title
Change from Baseline in Lupus-Specific Health-Related Quality-of-Life Questionnaire (LupusQoL) Score
Description
The LupusQoL is a participant-reported, lupus-specific, health-related quality-of-life questionnaire (HRQoL) 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 52
Title
Change from Baseline in Short Form Health Survey-36 (SF-36) Score
Description
SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary (PCS) score of SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement.
Time Frame
Up to Week 52
Title
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Description
FACIT-Fatigue is a participant-administered HRQoL questionnaire that evaluates participant's fatigue in the 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 52
Title
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
Description
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. 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 52
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. Presenteeism (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 scores indicating greater impairment and less productivity.
Time Frame
Up to Week 52
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. 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. An SAE is any untoward medical occurrence that at any dose results in death (a life-threatening event), in the view of the investigator, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a birth defect, or is a medically important event.
Time Frame
Up to Week 52
Title
Number of Participants with Antibodies to BIIB059
Time Frame
Up to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Antimalarials as stand-alone treatment
Antimalarial treatment in combination with OCS and/or a single immunosuppressant
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 hepatitis B surface antigen [HBsAg] and/or total hepatitis B core antibody [anti-HBc]).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial
Email
clinicaltrials@biogen.com
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 Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
480-321-8580
First Name & Middle Initial & Last Name & Degree
Areena Swarup
Facility Name
Valerius Medical Group
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-794-9801
First Name & Middle Initial & Last Name & Degree
Nathaniel Neal
Facility Name
Kotha
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
RASF - Clinical Research Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-361-6547
First Name & Middle Initial & Last Name & Degree
Joseph Forstot
Facility Name
University of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-273-5340
First Name & Middle Initial & Last Name & Degree
Michael Bubb
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-243-8567
First Name & Middle Initial & Last Name & Degree
Maria Carpintero
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-870-1292
First Name & Middle Initial & Last Name & Degree
Paul Lunseth
Facility Name
The Emory Clinic Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-616-3640
First Name & Middle Initial & Last Name & Degree
Sam Lim
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
856-325-6677
First Name & Middle Initial & Last Name & Degree
Brent Flickinger
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-358-9650
First Name & Middle Initial & Last Name & Degree
Monica Crespo-Bosque
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
508-334-0221
First Name & Middle Initial & Last Name & Degree
Jonathan Kay
Facility Name
Saint Louis Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
314-646-0688
First Name & Middle Initial & Last Name & Degree
Chad Ronholm
Facility Name
Arthritis & Osteoporosis Associates, PA
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
856-325-6677
First Name & Middle Initial & Last Name & Degree
Sylwia Sasinowska
Facility Name
Arthritis and Osteoporosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
575-532-5934
First Name & Middle Initial & Last Name & Degree
Arthur Synder
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
704-247-9179
First Name & Middle Initial & Last Name & Degree
Emily Jane Box
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
910-762-1182
First Name & Middle Initial & Last Name & Degree
Mark Harris
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
513-559-2370
First Name & Middle Initial & Last Name & Degree
Michael Luggen
Facility Name
STAT Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
937-887-9009
First Name & Middle Initial & Last Name & Degree
Chacko Alappatt
Facility Name
Piedmont Arthritis Clinic, P.A.
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-527-2307
First Name & Middle Initial & Last Name & Degree
Richard Kim
Facility Name
Low Country Rheumatology, PA
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29846
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
843-572-1818
First Name & Middle Initial & Last Name & Degree
Nicholas Holdgate
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
731-664-0002
First Name & Middle Initial & Last Name & Degree
Jacob Aelion
Facility Name
Office of John P. Lavery M.D., PA
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-747-0709
First Name & Middle Initial & Last Name & Degree
John Lavery
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
512-388-5717
First Name & Middle Initial & Last Name & Degree
Paul Pickrell
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-299-8399
First Name & Middle Initial & Last Name & Degree
Uzma Syeda
Facility Name
The University of Texas Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
SouthWest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-288-2600
First Name & Middle Initial & Last Name & Degree
Atul Singhal
Facility Name
Sun Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-227-4100
First Name & Middle Initial & Last Name & Degree
Leonel Reyes
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
206-386-2000
First Name & Middle Initial & Last Name & Degree
Philip Mease
Facility Name
Hospital General de Agudos Dr. J. M. Ramos Mejia
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+541149311178
First Name & Middle Initial & Last Name & Degree
Eduardo Kerzberg
Facility Name
Centro Privado de Medicina Familiar - Mind Out Research
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5491149273479
First Name & Middle Initial & Last Name & Degree
Leonardo Naftal
Facility Name
APRILLUS Asistencia e Investigacion
City
Ciudad Autonoma
State/Province
Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
CINME - Centro De Investigaciones Metabolicas
City
Ciudad Autonoma
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AXI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+542214176839
First Name & Middle Initial & Last Name & Degree
Garcia Salinas
First Name & Middle Initial & Last Name & Degree
Ro Nicholas
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AXI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+542214176839
First Name & Middle Initial & Last Name & Degree
Garcia Salinas
First Name & Middle Initial & Last Name & Degree
Rodrigo Nicholas
Facility Name
Centro de Investigaciones Medicas Mar del Plata
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5492235603218
First Name & Middle Initial & Last Name & Degree
Gladys Alicia Testa
Facility Name
Instituto de Investigaciones Clinicas Quilmes
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5491135804733
First Name & Middle Initial & Last Name & Degree
Velasco Zamora
First Name & Middle Initial & Last Name & Degree
Jose Luis
Facility Name
Centro Dermatologico Schejtman
City
San Miguel
State/Province
Buenos Aires
ZIP/Postal Code
B1663
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541145719929
First Name & Middle Initial & Last Name & Degree
Alejandro Martinez Muñoz
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+543814200180
First Name & Middle Initial & Last Name & Degree
Walter Spindler
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
T4000ICL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5493815932070
First Name & Middle Initial & Last Name & Degree
Veronica Ines Bellomio
Facility Name
Investigaciones Clinicas Tucuman
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000ICL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5493815932070
First Name & Middle Initial & Last Name & Degree
Veronica Ines Bellomio
Facility Name
STAT Research S.A.
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1013AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541561678705
First Name & Middle Initial & Last Name & Degree
Alejandro Brigante
Facility Name
Centro Privado de Medicina Familiar - Mind Out Research
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5491149273479
First Name & Middle Initial & Last Name & Degree
Leonardo Naftal
Facility Name
Instituto de Reumatologia
City
Mendoza
ZIP/Postal Code
M5500
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5492615440980
First Name & Middle Initial & Last Name & Degree
Alfredo Borgia
Facility Name
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
+5492645655194
First Name & Middle Initial & Last Name & Degree
Jose Luis Cristian Moreno
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3216342541
First Name & Middle Initial & Last Name & Degree
Ellen De Langhe
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3243667863
First Name & Middle Initial & Last Name & Degree
Christian Von Frenckell
Facility Name
The Waterside Clinic
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
7052521376
First Name & Middle Initial & Last Name & Degree
Derek Haaland
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
The 2nd Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
ZhuZhou Central Hospital
City
ZhuZhou
State/Province
Hunan
ZIP/Postal Code
412000
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Jiujiang No.1 People's Hospital
City
Jiujiang
State/Province
Jiujiang
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
ZIP/Postal Code
256603
Country
China
Individual Site Status
Recruiting
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Chengdu Medical College
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Xinjiang Uighur Autonomous Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Recruiting
Facility Name
Wenzhou People's Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
The Third Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Centro de Investigacion Medico Asistencial S.A.S
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clínica de la Costa Ltda.
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas CIREEM S.A.S.
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Servimed S.A.S.
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Recruiting
Facility Name
IPS Centro Medico Julián Coronel S.A.
City
Cali
ZIP/Postal Code
760001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Preventive Care Ltda
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fundacion Centro de Investigaciones Clinica Ips Cardiomet Pereira
City
Pereira
ZIP/Postal Code
660003
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Healthy Medical Center
City
Zipaquirá
ZIP/Postal Code
250252
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
ARTHROHELP s.r.o.
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsmedizin Goettingen
City
Gottingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+4915146509138
First Name & Middle Initial & Last Name & Degree
Peter Korsten
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+495115325252
First Name & Middle Initial & Last Name & Degree
Torsten Witte
Facility Name
Universitaetsklinikum Koeln
City
Koeln
State/Province
Nordrhein Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+492214783593
First Name & Middle Initial & Last Name & Degree
David Kofler
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
+496131176774
First Name & Middle Initial & Last Name & Degree
Julie Weinmann-Menke
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
+3614555700
First Name & Middle Initial & Last Name & Degree
Janos Kadar
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
3614555700
First Name & Middle Initial & Last Name & Degree
Janos Kadar
Facility Name
Egyesitett Szt. Istvan
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Bekes Varmegyei Kozponti Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
+36703678253
First Name & Middle Initial & Last Name & Degree
Tibor Martyin
Facility Name
Vita Verum Medical Egeszsegugyi Szolgaltato Bt.
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
+36304463463
First Name & Middle Initial & Last Name & Degree
Tunde Varga
Facility Name
Vital Medical Center
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
+36309930382
First Name & Middle Initial & Last Name & Degree
Edit Drescher
Facility Name
Rambam Health Care Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97247772988
First Name & Middle Initial & Last Name & Degree
Alexandra Balbir-Gurman
Facility Name
Meir Medical Center
City
Kfar- Sava
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+972523671735
First Name & Middle Initial & Last Name & Degree
Yair Levy
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97239376947
First Name & Middle Initial & Last Name & Degree
Yair Molad
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97235304413
First Name & Middle Initial & Last Name & Degree
Merav Lidar
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
Phone
+97236973668
First Name & Middle Initial & Last Name & Degree
Daphna Paran
Facility Name
Research Site
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
State/Province
Roma
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39658704218
First Name & Middle Initial & Last Name & Degree
Gian Domenico Sebastiani
Facility Name
Ospedale M. Scarlato
City
Scafati
State/Province
Salerno
ZIP/Postal Code
84018
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39815356111
First Name & Middle Initial & Last Name & Degree
Scarpato Salvatore
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39303995487
First Name & Middle Initial & Last Name & Degree
Franco Franceschini
Facility Name
Azienda Socio Sanitaria Territ
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39498214391
First Name & Middle Initial & Last Name & Degree
Luca Iaccarino
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39502218290
First Name & Middle Initial & Last Name & Degree
Marta Mosca
Facility Name
Università Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39862434745
First Name & Middle Initial & Last Name & Degree
Roberto Giacomelli
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
Phone
+39649974660
First Name & Middle Initial & Last Name & Degree
Fabrizio Conti
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Chibahigashi National Hospital
City
Chiba-shi
ZIP/Postal Code
260-8712
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Luke's International Hospital
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
KKR Hamanomachi Hospital
City
Fukuoka-shi
ZIP/Postal Code
810-8539
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Society Himeji Hospital
City
Himeji-shi
ZIP/Postal Code
670-8540
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-5881
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Iruma-gun
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Osaka Minami Medical Center
City
Kawachinagano
ZIP/Postal Code
586-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Mariana University Hospital
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagawa University Hospital
City
Kita-gun
ZIP/Postal Code
761-0793
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan
City
Kitakyushu-shi
ZIP/Postal Code
807-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe University Hospital
City
Kobe-shi
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toho University Ohashi Medical Center
City
Meguro-ku
ZIP/Postal Code
153-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
JCHO Chukyo Hospital
City
Nagoya-shi
ZIP/Postal Code
457-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chibaken Saiseikai Narashino Hospital
City
Narashino-shi
ZIP/Postal Code
275-8580
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitano Hospital
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toho University Omori Medical Center
City
Ota-ku
ZIP/Postal Code
143-8541
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitasato University Hospital
City
Sagamihara-shi
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tonan Hospital
City
Sapporo-shi
ZIP/Postal Code
060-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai-shi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Global Health and Medicine
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Takatsuki-shi
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Yokohama Medical Center
City
Yokohama-shi
ZIP/Postal Code
245-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Center
City
Yokohama
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC, Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+31204444444
First Name & Middle Initial & Last Name & Degree
Ronald van Vollenhoven
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+31503616161
First Name & Middle Initial & Last Name & Degree
Karina De Leeuw
Facility Name
Maastricht Univ Med Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
Phone
+313188755050
First Name & Middle Initial & Last Name & Degree
Maarten Limper
Facility Name
Centro Reumatologico
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
Phone
7874471491
First Name & Middle Initial & Last Name & Degree
Amarilis Perez De Jesus
Facility Name
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
+40722530460
First Name & Middle Initial & Last Name & Degree
Liliana Duca
Facility Name
S.C Dental Health Care SRL
City
Bucuresti
ZIP/Postal Code
014142
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
+40745088514
First Name & Middle Initial & Last Name & Degree
Bogdan Horia Chicos
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
+40264591942
First Name & Middle Initial & Last Name & Degree
Simona Rednic
Facility Name
S.C.Centrul Medical Unirea SRL
City
Iasi
ZIP/Postal Code
700023
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
+40740063687
First Name & Middle Initial & Last Name & Degree
Codrina Irena Mihaela Ancuta
Facility Name
Spitalul Judetean de Urgenta "Sf. Ioan cel Nou" Suceava
City
Suceava
ZIP/Postal Code
720284
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
S.C Centrul Medical Unirea SRL
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
+40725511508
First Name & Middle Initial & Last Name & Degree
Monica Chis
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
+381113600801
First Name & Middle Initial & Last Name & Degree
Goran Radunovic
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
+381648833030
First Name & Middle Initial & Last Name & Degree
Mirjana Sefik Bukilica
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
+381113663700
First Name & Middle Initial & Last Name & Degree
Snezana Arandjelovic
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
381113663700
First Name & Middle Initial & Last Name & Degree
Snezana Arandjelovic
Facility Name
Clinical Hospital Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
+381112095617
First Name & Middle Initial & Last Name & Degree
Gordana Bogdanovic
Facility Name
Institute of Treatment and Rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
Phone
+38118502045
First Name & Middle Initial & Last Name & Degree
Jovan Nedovic
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+442034165000
First Name & Middle Initial & Last Name & Degree
Angela Pakozdi
Facility Name
Guy's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+442071887188
First Name & Middle Initial & Last Name & Degree
David DCruz
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441302644482
First Name & Middle Initial & Last Name & Degree
Chee-Seng Yee
Facility Name
Cannock Chase Hospital
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
+441543576449
First Name & Middle Initial & Last Name & Degree
Thomas Sheeran
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Not yet recruiting
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/
Links:
URL
https://www.topazlupusstudy.com/
Description
Click here to learn more about this trial, visit our study website.
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care
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