Study Description
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 360 PMR patients who had recently relapsed. The study consists of: screening (up to 6 weeks); treatment period (52 weeks, with last IMP administration at 48 weeks, active drug or placebo) in combination with prednisone tapered over 24 weeks; treatment-free follow-up (up to 24 weeks). Adult males and females of at least 50 years of age with a recent PMR relapse (within 12 weeks from Baseline) will be included. Dosing will be once every week for the first 4 weeks, and once every 4 weeks thereafter via pre-filled syringe.
The primary objective is to demonstrate the efficacy of secukinumab 300 mg subcutaneously in combination with a 24-week glucocorticoid (GC) taper regimen compared with placebo with respect to the proportion of patients in sustained remission at Week 52. Primary secondary objectives are to assess difference in proportion of patients achieving complete sustained remission at Week 52, adjusted annual cumulative GC dose and time to first use of escape treatment or rescue treatment through Week 52. Key safety data will be collected, along with Patient Reported Outcomes.
Interventions
Placebo to secukinumab
Secukinumab 150 mg
Secukinumab 300 mg
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study
Male or non-pregnant, non-lactating female participants at least 50 years of age.
Diagnosis of PMR according to the provisional American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria: Participants ≥ 50 years of age with a history of bilateral shoulder pain accompanied by elevated C-reactive protein (CRP) concentration (≥ 10 mg/L) and/or elevated erythrocyte sedimentation rate (ESR) (≥ 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
Morning stiffness > 45 minutes (min) (2 points)
Hip pain or restricted range of motion (1 point)
Absence of rheumatoid factor and/or anti-citrullinated protein antibodies (2 points)
Absence of other joint involvement (1 point)
Participants must have a history of being treated for at least 8 consecutive weeks with prednisone (≥ 10 mg/day or equivalent) at any time prior to screening
Participants must have had at least one episode of PMR relapse while attempting to taper prednisone at a dose that is ≥ 5 mg/day (or equivalent) within the past 12 weeks prior to BSL. Diagnosis of a PMR relapse is defined as participant meeting both of the following:
Recurrence of bilateral shoulder girdle and/or bilateral hip girdle pain associated with inflammatory stiffness with or without additional symptoms indicative of PMR relapse (such as constitutional symptoms) within 12 weeks prior to BSL that are in the opinion of the Investigator not due to other diseases that may mimic PMR such as osteoarthritis in shoulders or hips, polyarticular calcium pyrophosphate deposition disease, rotator cuff disease, adhesive capsulitis (frozen shoulder) or fibromyalgia.
Elevated ESR (≥ 30 mm/hr) and/or elevated CRP (> upper limit of normal (ULN)) attributable to PMR at the time of relapse and/or at screening
Participants must have been treated as per local treatment recommendations following the latest PMR relapse and must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 25 mg/day at screening and during the screening period
Exclusion Criteria:
Evidence of GCA as indicated by typical (cranial) symptoms (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, blurry or loss of vision, symptoms of stroke), extremity claudication, imaging and/or temporal artery biopsy result
Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis
Concurrent diagnosis or history of neuropathic muscular diseases
Inadequately treated hypothyroidism (e.g., persistence of symptoms, lack of normalization of serum TSH despite regular hormonal replacement treatment)
Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
Participants treated with tocilizumab or other IL-6/IL6-receptor inhibitors within 12 weeks or within 5 half-lives (whichever is longer) prior to BSL; participant who did not respond to or experienced a relapse during treatment are excluded from enrollment into the study Other protocol-defined inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
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Ciudad Autonoma de Bs As,Buenos Aires,C1055AAF,Argentina
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Ciudad Autonoma de Bs As,Buenos Aires,C1119ACN,Argentina
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Quilmes,Buenos Aires,B1878GEG,Argentina
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Hobart,Tasmania,7000,Australia
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Parramatta,2150,Australia
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Heidelberg Heights,Victoria,3081,Australia
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Westmead,New South Wales,2145,Australia
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Southport,Queensland,4215,Australia
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Leuven,3000,Belgium
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Liege,4000,Belgium
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Porto Alegre,RS,90480-000,Brazil
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Sao Paulo,01409-902,Brazil
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Salvador,BA,40150 150,Brazil
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Sao Paulo,SP,04038-002,Brazil
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Rio de Janeiro,RJ,22211 230,Brazil
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Quebec,G1V 3M7,Canada
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Montreal,Quebec,H4J 1C5,Canada
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Santiago,RM,8380465,Chile
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Santiago,7500571,Chile
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Vina del Mar,Region De Valparaiso,2520598,Chile
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Santiago,7500710,Chile
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Vitacura,Santiago,7640881,Chile
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Santiago,8420383,Chile
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Barranquilla,Atlantico,080002,Colombia
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Barranquilla,080020,Colombia
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Bogota,110221,Colombia
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Uherske Hradiste,686 01,Czech Republic
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Praha 2,128 50,Czech Republic
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Zlin,760 01,Czech Republic
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Praha 4,Czech Republic,140 00,Czech Republic
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Hlucin,Czech Republic,748 01,Czech Republic
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Brno,63800,Czech Republic
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Esbjerg,DK-6700,Denmark
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Vejle,DK-7100,Denmark
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Aarhus,8000,Denmark
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Gandrup,9362,Denmark
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Limoges,Haute Vienne,87000,France
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Paris 13,75651,France
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Strasbourg,67000,France
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Reims Cedex,51092,France
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Colmar Cedex,68024,France
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Montpellier Cedex 5,34295,France
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Le Mans,72037,France
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Corbeil Essonnes,91100,France
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Aix en Provence,13616,France
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Chambray les Tours,37170,France
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Brest,29200,France
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Dijon,21034,France
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Toulon Cedex 9,Val De Marne,83800,France
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Cholet,49325,France
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Angers Cedex 9,49933,France
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Nantes Cedex 1,44093,France
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Toulouse,31059,France
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Ratingen,40878,Germany
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Erlangen,91056,Germany
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Koeln,50937,Germany
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Freiburg,79106,Germany
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Ludwigshafen,67063,Germany
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Bad Doberan,18209,Germany
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Herne,44649,Germany
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Berlin,13125,Germany
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Wuerzburg,97080,Germany
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Dresden,01307,Germany
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Berlin,13353,Germany
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Budapest,1027,Hungary
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Nyiregyhaza,4400,Hungary
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Szeged,6720,Hungary
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Veszprem,8200,Hungary
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Holon,58100,Israel
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Tel Aviv,6423906,Israel
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Ramat Gan,52621,Israel
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Milano,MI,20122,Italy
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Milano,MI,20132,Italy
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Firenze,FI,50134,Italy
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Reggio Emilia,RE,42123,Italy
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Milano,MI,20157,Italy
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Pavia,PV,27100,Italy
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Bolzano,BZ,39100,Italy
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Perugia,PG,06100,Italy
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Sagamihara-city,Kanagawa,252-0392,Japan
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Kita-gun,Kagawa,761-0793,Japan
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Yokohama,Kanagawa,222-0036,Japan
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Chuo-city,Yamanashi,409-3898,Japan
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Bunkyo ku,Tokyo,113-8431,Japan
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Asahikawa-city,Hokkaido,070-8644,Japan
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Okayama-city,Okayama,700-8607,Japan
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Ome,Tokyo,198-0042,Japan
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Ichikawa,Chiba,272-8516,Japan
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Omura,Nagasaki,856-0836,Japan
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Fuchu,Tokyo,183-8524,Japan
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Beppu,Oita,874-0011,Japan
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Shimonoseki,Yamaguchi,750-0041,Japan
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Osaka-City,Osaka,550-0006,Japan
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Nagano-city,Nagano,380-8582,Japan
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Fukuoka city,Fukuoka,814 0180,Japan
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Kawachinagano,Osaka,586-8521,Japan
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Osaka,534-0021,Japan
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Saida,652,Lebanon
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Ashrafieh,166830,Lebanon
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Beirut,1107 2020,Lebanon
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Guadalajara,Jalisco,44650,Mexico
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Mazatlan,Sinaloa,82140,Mexico
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Groningen,9713 GZ,Netherlands
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Groningen,9728 NZ,Netherlands
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Rotterdam,3079 DZ,Netherlands
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Almelo,7609 PP,Netherlands
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Warszawa,00-909,Poland
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Warszawa,02 118,Poland
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Lublin,20-607,Poland
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Warszawa,02 637,Poland
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Bytom,41 902,Poland
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Warszawa,02-665,Poland
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Panorama,7500,South Africa
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Stellenbosch,7600,South Africa
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Cape Town,7405,South Africa
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Bilbao,Pais Vasco,48013,Spain
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Valencia,Comunidad Valenciana,46010,Spain
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Santiago De Compostela,Galicia,15706,Spain
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La Coruna,Galicia,15006,Spain
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Sevilla,Andalucia,41013,Spain
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Madrid,28009,Spain
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Madrid,28046,Spain
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Barcelona,08041,Spain
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Sabadell,Barcelona,08208,Spain
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St Gallen,9007,Switzerland
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Basel,4031,Switzerland
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Fribourg,1708,Switzerland
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Ankara,Cankaya,06100,Turkey
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Kocaeli,41380,Turkey
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Pendik,Istanbul,34899,Turkey
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Birkenhead,Wirral,CH49 5PE,United Kingdom
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Hull,HU3 2JZ,United Kingdom
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Barnet,EN5 3DJ,United Kingdom
Low Country Rheumatology PA Articulitis Healthcare
Recruiting
Charleston,Emily Caudle email: [email protected] -- Gregory Niemer,29460 - South Carolina,United States
Sun Valley Arthritis Center Ltd
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Peoria,(623-825-5591) -- Joy Schechtman,85381 - Arizona,United States
Good Samaritan Regional Medical Ctr Rheumatology
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Corvallis,Stephanie Mock (541-768-5800) email: [email protected] -- Jonathan Jones,97330 - Oregon,United States
Providence Saint Johns Health Ctr Main
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Santa Monica,Olga Pimienta email: [email protected] -- Orrin Troum,90404 - California,United States
Arthritis Northwest PLLC .
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Spokane,Shane White (+1 509 838 6500#307) email: [email protected] -- Michael C Coan,99204 - Washington,United States
Massachusetts General Hospital
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Boston,(617-726-7938) -- Sebastian Unizony,02114 - Massachusetts,United States
UF Health Cancer Center Rheumatology
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Gainesville,Roland Staud,32608 - Florida,United States
Hospital for Special Surgery
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New York,(212-774-7194) -- Robert Spiera,10021 - New York,United States
Rheuma Asso of South Florida
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Boca Raton,(561-361-6547) -- Shawn Baca,33486 - Florida,United States
AZ Arthritis and Rheumtlgy Rsh PLLC
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Phoenix,Rosemary Gunderson email: [email protected] -- Andrew Sharobeem,85032 - Arizona,United States
Millennium Clinical Trials
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Simi Valley,Elvira Lindwall,93065 - California,United States
Paramount Med Rsrch and Consult LLC
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Middleburg Heights,(440-826-0742) -- Isam Diab,44130 - Ohio,United States
West Broward Rheumatology Assoc Inc
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Tamarac,(954-545-8400) -- Alan R Alberts,33321 - Florida,United States
Inspire Santa Fe Medical Group Rheumatology
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Santa Fe,Lisa Chavez email: [email protected] -- Hillary Norton,87505 - New Mexico,United States
Sarasota Arthritis Research Center
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Sarasota,(941-366-1244) -- Jesse Boodoo,34239 - Florida,United States
Center for Rheumatology Research Rheumatology
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West Hills,Tannia Villalobos email: [email protected] -- Nazanin Firooz,91307 - California,United States
Piedmont Hospital .
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Atlanta,Tia Dixon email: [email protected] -- Wambui Machua,30309 - Georgia,United States
West Tennessee Research Institute
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Jackson,(731-664-7824) -- Jacob A. Aelion,38305 - Tennessee,United States
Accurate Clinical Research, Inc. .
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San Antonio,Luis Lopez email: [email protected] -- Philip Waller,78229 - Texas,United States
Kansas City Physician Partners
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Kansas City,Tina Shah,64111 - Missouri,United States
Shores Rheumatology
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Saint Clair Shores,Latrece Keaton (586-777-7577) email: [email protected] -- Andrew Sulich,48081 - Michigan,United States
Dartmouth Hitchcock Medical Center
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Lebanon,Shikha Shah (603-650-6228) email: [email protected] -- William Rigby,03756 - New Hampshire,United States
Precn Comprehensive Clnl Rsch Solns
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San Leandro,Swapna Manepalli (510-357-1040) email: [email protected] -- Suneet Grewal,94578 - California,United States
Advanced Rheumatology of Houston .
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Spring,David Ekunno (281-766-7886) email: [email protected] -- Tamar Brionez,77382 - Texas,United States
Novartis Investigative Site
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Iowa City,Iowa,52242,United States
Klein and Associates Rheumatology
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Cumberland,Steven J Klein,21740 - Maryland,United States
Southwest Rheumatology Research LLC
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Mesquite,Daisy Zambrana (972-288-2600) email: [email protected] -- Atul K K. Singhal,75150 - Texas,United States
DM Clinical Research Rheumatology
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Houston,Ankit Dasgupta email: [email protected] -- Shaikh Arif Ali,77070 - Texas,United States
Prolato Clinical Research Center .
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Houston,Mohammad Alsayed (832-338-9118) email: [email protected] -- Michelle Eisenberg,77054 - Texas,United States
Arizona Arthritis and Rheumatology Associates PLLC .
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Paradise Valley,Francesca Ingram (480-626-6650) email: [email protected] -- Swati Bharadwaj,85253 - Arizona,United States
Stryde Research-Allen Arthritis
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Allen,Asma Hussain (972-747-0709) email: [email protected] -- John Lavery,75013 - Texas,United States
Florida Medical Clinic PA .
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Zephyrhills,(813-782-1234) -- David H Sikes,33542 - Florida,United States
Providence Medical Center
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Burbank,Maria Hernandez (818-869-7600) email: [email protected] -- Hitasha Singh,91505 - California,United States
Arthritis Center of North Georgia
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Gainesville,(678-677-8824) -- Brent Flickinger,30501 - Georgia,United States
Worldwide Contacts
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