Study Description
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous). using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).
Interventions
ianalumab s.c. q12w
ianalumab s.c. q4w
placebo s.c.
Eligibility Criteria
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
Adult male and female participants aged 18 years or older at the time of screening
Weigh at least 35 kg at screening
Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria
Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result
Active LN at screening, as defined by meeting the 3 following criteria:
Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN. If no biopsy was performed within 6 months prior to screening period, a biopsy will need to be performed during the screening period after having met all other inclusion/exclusion criteria.
UPCR ≥ 1.0 g/g on 24h urine collection at Screening
eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR < 30 mL/min/1.73 m2 require renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
Newly diagnosed participants as well as pre-treated LN participants (including refractory cases) can be included, as long as they are currently on, or willing to initiate SoC induction therapy for LN using MPA
Induction therapy, as defined by treatment including both high dose corticosteroids and MPA, should be initiated prior to or on day of randomization
Anti-malarial treatment at stable dosing prior to randomization is strongly recommended, in the absence of contraindications
Participants on azathioprine treatment at Screening must be switched to MPA prior to randomization
Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day up to 3000 mg cumulative dose) or equivalent for treatment of current episode of active LN within 60 days prior randomization. Participant who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg/day (max 80mg/day) oral predniso(lo)ne.
Able to communicate well with the Investigator to understand and comply with the requirements of the study
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study:
Severe renal impairment as defined by i.) presence of oliguria (defined as a documented urine volume <400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD) requiring dialysis or transplantation
Sclerosis in > 50% of glomeruli on renal biopsy
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline. Use of certain Traditional Chinese Medicines
Prior use of ianalumab (ever); or prior use other B cell depleting therapy within 36 weeks prior to randomization or if therapy was administered < 36 weeks prior to randomization, B cell count less than the lower limit of normal or patient's own baseline value prior to having received an earlier B cell-depleting therapy
Prior treatment with any of the following within 12 weeks prior to randomization
Belimumab, telitacicept, abatacept, TNF-α mAb, immunoglobulins (i.v./s.c.) plasmapheresis
Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin inhibitors, JAK inhibitors or other kinase inhibitors)
Thalidomide treatment and/or methotrexate
Combination of DMARDs
Imidazole derivative (e.g., azathioprine, mizoribine) must be discontinued prior to starting treatment with MPA
Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12 weeks prior to randomization
History of major organ transplant or hematopoietic stem cell/bone marrow transplant or are due to receive transplantation
Any one of the following laboratory values at screening:
Hemoglobin levels < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) if related to participant's SLE such as in active hemolytic anaemia
Platelet count < 25 x 1000/µL
Absolute neutrophil count (ANC) < 0.8 x 1000/µL
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection or history of recurrent clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any component of the study drug(s) or its excipients
Receipt of live/attenuated vaccine within a 4-week period prior to randomization
History of primary or secondary immunodeficiency, including a positive HIV test result
History of malignancy of any organ system (other than localized basal cell carcinoma or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes), psychiatric or additional physical condition that the Investigator feels may jeopardize the participants in case of participation in this study
Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for hepatitis B surface antigen (HBsAg) excludes the participant
Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants with history of TB may become eligible according to national local guidelines)
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 6 months after stopping of investigational medication
Sexually active male participants, who do not agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment
Other protocol -defined Inclusion/Exclusion may apply.
Study Location
Novartis Investigative Site
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Caba,Buenos Aires,C1056ABJ,Argentina
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Ciudad Autonoma de Bs As,Buenos Aires,C1119ACN,Argentina
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Ciudad Autonoma de Buenos Aire,1426,Argentina
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Salvador,BA,40150 150,Brazil
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Vitoria,ES,29055 450,Brazil
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Salvador,40301-155,Brazil
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Pernambuco,Recife,50740-900,Brazil
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Belo Horizonte,MG,30150-221,Brazil
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Santo Andre,SP,09090-790,Brazil
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Porto Alegre,RS,90020-090,Brazil
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Curitiba,PR,80440-020,Brazil
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Juiz de Fora,MG,36010 570,Brazil
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Porto Alegre,RS,90035-003,Brazil
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Sherbrooke,Quebec,J1G 2E8,Canada
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London,Ontario,N6A 5A5,Canada
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Santiago,RM,7500922,Chile
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Temuco,4790084,Chile
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Shanghai,200127,China
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Shenzhen,Guangdong,518020,China
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Haikou,Hainan,570311,China
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Guangzhou,510280,China
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Shantou,Guangdong,515041,China
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Shenzhen,Guangdong,518037,China
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Chongqing,400038,China
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Guangzhou,Guangdong,51000,China
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Linyi,Shandong,276000,China
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Wuhan,430022,China
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Nanchang,Jiangxi,330006,China
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Beijing,100034,China
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Hefei,Anhui,230022,China
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Guangzhou,Guangdong,510000,China
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Liuzhou,Guangxi,545005,China
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Wuhan,Hubei,430060,China
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Nanjing,Jiangsu,210029,China
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Changchun,Jilin,130041,China
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Xi'an,Shanxi,710004,China
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Shanghai,200040,China
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Zhanjing,Guangong,524000,China
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Changsha,Hunan,410008,China
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Shanghai,200080,China
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Shenyang,Liaoning,110003,China
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Binzhou,Shandong,256603,China
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Zhejiang,315016,China
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Chengdu,Sichuan,610041,China
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Guang Zhou,510080,China
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Bogota,Cundinamarca,110111,Colombia
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Barranquilla,080020,Colombia
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Medellin,Antioquia,050001,Colombia
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Prague 2,128 50,Czech Republic
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Olomouc,779 00,Czech Republic
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Tallinn,10117,Estonia
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Tallinn,10138,Estonia
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Lyon,69437,France
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Angers Cedex 1,49033,France
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Bordeaux,33067,France
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Marseille,13385,France
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Poitiers,86000,France
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Besancon Cedex,25030,France
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Grenoble,38043,France
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Aachen,52074,Germany
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Muenster,48149,Germany
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Herne,44625,Germany
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Regensburg,Bavaria,93053,Germany
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Quetzaltenango,9001,Guatemala
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Guatemala City,01011,Guatemala
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Guatemala,01010,Guatemala
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Tuen Mun,999077,Hong Kong
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Kwun Tong,Kowloon,Hong Kong
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Kaposvar,7400,Hungary
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Debrecen,4032,Hungary
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Budapest,1097,Hungary
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Budapest,H-1032,Hungary
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Bangalore,Karnataka,560 079,India
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Chandigarh,160 012,India
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Secunderabad,Telangana,500003,India
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Lucknow,Uttar Pradesh,226014,India
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Torino,TO,10154,Italy
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Pavia,PV,27100,Italy
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Udine,UD,33100,Italy
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Firenze,FI,50139,Italy
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Napoli,80131,Italy
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Roma,RM,00168,Italy
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Milano,MI,20132,Italy
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Bundang Gu,Gyeonggi Do,13620,Korea, Republic of
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Daegu,705 718,Korea, Republic of
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Seoul,04763,Korea, Republic of
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Busan,602 715,Korea, Republic of
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Daejeon,Korea,35015,Korea, Republic of
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Seoul,05030,Korea, Republic of
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Seoul,06591,Korea, Republic of
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Seoul,Korea,05505,Korea, Republic of
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Gwangju,61469,Korea, Republic of
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Seoul,03722,Korea, Republic of
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Suwon si,Gyeonggi Do,16499,Korea, Republic of
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Vilnius,LT-08661,Lithuania
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Kaunas,LTU,LT 50161,Lithuania
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Sibu,Sarawak,96000,Malaysia
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Kuala Lumpur,50589,Malaysia
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Kuala Terengganu,Terengganu,20400,Malaysia
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Monterrey,Nuevo Leon,64440,Mexico
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Leon,Guanajuato,37160,Mexico
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Queretaro,76070,Mexico
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Oaxaca,68020,Mexico
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Timisoara,300736,Romania
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Oradea,Jud. Bihor,410619,Romania
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Ramnicu Valcea,Valcea,240672,Romania
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Bucharest,022328,Romania
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Cluj Napoca,400006,Romania
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Singapore,169608,Singapore
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Singapore,308433,Singapore
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La Laguna,Santa Cruz De Tenerife,38320,Spain
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Barcelona,Catalunya,08035,Spain
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Madrid,28040,Spain
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Santiago De Compostela,Galicia,15706,Spain
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Madrid,28041,Spain
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El Palmar,Murcia,30120,Spain
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Valencia,Comunidad Valenciana,46017,Spain
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Vigo,Pontevedra,36200,Spain
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Barcelona,Catalunya,08003,Spain
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Kaohsiung,83301,Taiwan
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Taichung,40447,Taiwan
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Taichung,407,Taiwan
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Taipei,11217,Taiwan
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Chiang Mai,50200,Thailand
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Hat Yai,Songkla,90110,Thailand
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Bangkok,10330,Thailand
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Bangkok,10400,Thailand
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Bangkok,10700,Thailand
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Bradford,West Yorkshire,BD9 6RJ,United Kingdom
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London,SE1 9RT,United Kingdom
University Of Cincinnati .
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Cincinnati,(513-559-3362) -- Manish Anand,45267 - Ohio,United States
Fides Clinical Research
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Atlanta,Tu Tran (404-252-0256) email: [email protected] -- Elizabeth Nguyen,30342 - Georgia,United States
NY Nephrology
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Clifton Park,(518-579-0017) -- Frank Cortazar,12065 - New York,United States
University of Kansas Medical Center CRAD001A2433
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Kansas City,(913-588-0053) -- Kelly Liang,66160-7330 - Kansas,United States
James J Peters VA Medical Center
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Bronx,(+17185849000#6667) -- Kelly Steed,10468 - New York,United States
Parris and Associates Rheumatology
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Lawrenceville,(+17709621616#8334) -- Glenn Parris,30044 - Georgia,United States
University of Texas Medical Branch .
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Galveston,Jana Lee (409-772-1062) email: [email protected] -- Tina Kochar,77555-0144 - Texas,United States
Kaiser Permanente Dpt of Research and Evaluation
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San Diego,Sinai Farah (858-401-7205) email: [email protected] -- Hui Xue,92111 - California,United States
UMC New Orleans Nephrologist
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New Orleans,Khahtahvah Joseph email: [email protected] -- Stephen Lindsey,70112 - Louisiana,United States
Univof Texas Southwestern Med Cntr Dept Of Pediatrics
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Dallas,David Karp,75235 - Texas,United States
Liberty Research Center
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Dallas,Laurie Jones (972-274-5555) email: [email protected] -- Irfan Agha,75230 - Texas,United States
Uni of Texas Health Science Center
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San Antonio,(210-617-5111) -- Agustin Escalante,78284 - Texas,United States
Baylor Scott and White Research
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Temple,Michell Trevino (254-935-5838) email: [email protected] -- Mohanram Narayanan,76502 - Texas,United States
VA NM Healthcare System
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Albuquerque,Kelli Ober (505-265-1711) email: [email protected] -- Kavitha Ganta,87108 - New Mexico,United States
Mayo Clinic Jacksonville .
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Jacksonville,Carolyne Stevens (904-953-2451) email: [email protected] -- Nabeel Aslam,32224 - Florida,United States
Uni Wisconsin School Med Pub Health Clinical Research Office
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Madison,Wayne Dorsey email: [email protected] -- Tripti Singh,53792 - Wisconsin,United States
Brookview Hills Research Assoc Brookwood Hills Research Assoc
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Winston-Salem,Janice Rogers (336-768-2425) email: [email protected] -- Nicholas McLean,27103 - North Carolina,United States
Wallace Rheumatic Study Center Research Department
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Los Angeles,Carla Martinez email: [email protected] -- Daniel Wallace,90048 - California,United States
University of California Irvine Research Department
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Orange,Ahmad Walid Roshan email: [email protected] -- Sheetal Desai,92868 - California,United States
Northern Assoc of Northern VA
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Fairfax,(703-953-0155) -- Gregory Wang,22033 - Virginia,United States
Circuit Clinical Clinical Research
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Orchard Park,Sara Behrbom email: [email protected] -- Isha Gupta,14127 - New York,United States
Wayne State University
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Detroit,Danial Rashid (313-745-7371) email: [email protected] -- Yahya Osman,48201 - Michigan,United States
Novartis Investigative Site
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Hanoi,100000,Vietnam
Novartis Investigative Site
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Ho Chi Minh,700000,Vietnam
Worldwide Contacts
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