Clinical trial NCT06104124: A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sjogren's Syndrome
Keywords: Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity Study Phase: Phase 3
European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI)
European Alliance of Associations for Rheumatology Sjögren's Syndrome Patient Reported Index (ESSPRI)
European Alliance of Associations for Rheumatology (EULAR)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 621
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.

Secondary Objectives:

1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Detailed description: Acquired from Horizon in 2024.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
* Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of \>= 5 despite symptomatic or local therapy at screening.
* Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Key Exclusion Criteria:

* Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
* Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy \> 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
* Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.
* Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
* Active TB or untreated (per local guidelines) latent TB
* Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
* Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
* Last administration of experimental or investigational biologic or oral agents \< 6 months prior to screening.
* Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) \< 3 months prior to screening.

Primary outcomes:
measure: Change from baseline in European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) Score
timeFrame: At Week 48
Secondary outcomes:
measure: Proportion of participants achieving ESSDAI response
timeFrame: At Week 48
measure: Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) dryness domain score
timeFrame: At Week 48
measure: Change from baseline in ESSPRI dryness domain score
timeFrame: At Week 48
measure: Change from baseline in DASPRI dryness domain score
timeFrame: At Week 48
measure: Change from baseline in tender and swollen joint counts
timeFrame: At Week 48
measure: Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue-SF-10a)
timeFrame: At Week 48
measure: Change from baseline in ESSDAI score
timeFrame: Week 12 and Week 24
measure: Change from baseline in DASPRI total score
timeFrame: At Week 48
measure: Change from baseline in ESSPRI total score
timeFrame: At Week 48
measure: Change from baseline in total stimulated salivary flow
timeFrame: At Week 48
measure: Number of participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline (Day 1) to Week 56
measure: Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 56
measure: Number of participants With Adverse Events of Special Interest (AESIs)
timeFrame: Up to Week 56
Other outcomes:
Locations:
city: Avondale
country: United States
facility: Arizona Arthritis & Rheumatology Associates - Avondale
state: Arizona
city: Chandler
country: United States
facility: Arizona Research Clinic PLLC
state: Arizona
city: Flagstaff
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln
state: Arizona
city: Gilbert
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd
state: Arizona
city: La Jolla
country: United States
facility: UCSD Altman Clinical and Translational Research Institute Building
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Incorporated
state: California
city: Fort Collins
country: United States
facility: Tekton Research, LLC - 2121 E Harmony Rd - PPDS
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Research Center Inc
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc - Clearwater
state: Florida
city: Coral Gables
country: United States
facility: Life Arc Research
state: Florida
city: Miami
country: United States
facility: University of Miami - Leonard M. Miller School of Medicine
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research - ATLAS - New Port Richey - PPDS
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group
state: Florida
city: Augusta
country: United States
facility: Augusta University Medical Center-Augusta-1120 15th St
state: Georgia
city: Rockford
country: United States
facility: OrthoIllinois, LTD
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Physician Partners-8350 N Saint Clair Ave
state: Missouri
city: Las Vegas
country: United States
facility: Kirk Kerkorian School of Medicine UNLV
state: Nevada
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Bone Disease Associates - P
state: New Jersey
city: Brooklyn
country: United States
facility: NYU Langone Health - Joseph S. and Diane H. Steinberg Ambulatory Care Center
state: New York
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of The Carolinas
state: North Carolina
city: Durham
country: United States
facility: Duke Early Phase Clinical Research Unit
state: North Carolina
city: Salisbury
country: United States
facility: Onsite Clinical Solutions, LLC - Salisbury
state: North Carolina
city: Miamisburg
country: United States
facility: Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Vandalia
country: United States
facility: STAT Research-600 Aviator Ct
state: Ohio
city: Summerville
country: United States
facility: Low Country Rheumatology PA-Summerville
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfreesboro Medical Clinic Westlawn
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research - ClinEdge - PPDS
state: Texas
city: Austin
country: United States
facility: Tekton Research, LLC - W Gate Blvd - Austin - PPDS
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management-Baytown
state: Texas
city: Grapevine
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research-777 S Fry Rd
state: Texas
city: McAllen
country: United States
facility: Valley Arthritis Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas - San Antonio - Health Science Center - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Migraine and COPD - PPDS
state: Texas
city: West Valley City
country: United States
facility: Metrodora Institute
state: Utah
city: Bellevue
country: United States
facility: Overlake Arthritis & Osteoporosis Center
state: Washington
city: Bothell
country: United States
facility: Western Washington Medical Group, Bothell - Rheumatology
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sanatorio Agote - Swiss Medical Group - PPDS
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Sanatorio Guemes
state: Buenos Aires
city: La Plata
country: Argentina
facility: Framingham Centro Médico
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto CER S.A.
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes SRL
state: Buenos Aires
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. José María Ramos Mejia
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalén Salud e Investigación
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski - PPDS
state: Ciudad Autónoma De BuenosAires
city: Ciudad De Cordoba
country: Argentina
facility: Sanatorio Allende S.A
state: Córdoba
city: San Miguel de Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucumán - PPDS
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Reumatológicas
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Clínica Mayo de U.M.C.B. S.R.L
state: Tucumán
city: Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigacion de Arcis Salud SRL
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Medico Arsema
city: San Juan
country: Argentina
facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Salvador
country: Brazil
facility: SER - Serviços Especializados em Reumatologia da Bahia S/S - ME
state: Bahia
city: Belo Horizonte
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras
state: Paraná
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos SS
state: Rio Grande Do Sul
city: Trois Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
state: Quebec
city: Temuco
country: Chile
facility: Centro de especialidades médicas Vanguardia
state: Araucanía
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA - PPDS
state: Los Ríos
city: Providencia
country: Chile
facility: Enroll SpA - Dr. Manuel Barros Borgono - PPDS
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: BIOCINETIC Ltda
state: Región-MetropolitanadeSantiago
city: Vina del Mar
country: Chile
facility: Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
state: Valparaíso
city: Zagreb
country: Croatia
facility: Clinical Center Zagreb - Oncology - Salata 7 - PPDS
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Sveti Duh
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Bonifarm-Hondlova 2/10
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Split
country: Croatia
facility: University Hospital of Split-Spinciceva 1
city: Odense C
country: Denmark
facility: Odense Universitets Hospital
state: South Denmark
city: Mulhouse
country: France
facility: Hopital Emile Muller
state: Haut-Rhin
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne - Hôpital Nord
state: Loire
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint-André
city: Brest
country: France
facility: CHU de Brest - Hôpital La Cavale Blanche
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP - Hôpital Bicêtre
city: Paris
country: France
facility: AP-HP - Hôpital Saint Antoine
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
state: Baden-Württemberg
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan
state: Mecklenburg-Vorpommern
city: Greifswald Hansestadt
country: Germany
facility: Rheumazentrum Greifswald
state: Mecklenburg-Vorpommern
city: Chemnitz
country: Germany
facility: DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein
city: Hamburg
country: Germany
facility: MVZ Rheuma
city: Patra
country: Greece
facility: Olympion General Clinic-Duplicate
state: Achaïa
city: Athina
country: Greece
facility: Naval Hospital of Athens
state: Attiki
city: Athina
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Voula
country: Greece
facility: General Hospital ''Asklepieio Voulas''
state: Attiki
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Larisa
city: Thessaloniki
country: Greece
facility: Euromedica Kianous Stavros
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz
state: Békés
city: Hódmezővásárhely
country: Hungary
facility: Vasarhelyi Sarkanyfu Kft.
state: Csongrád
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Szent Laszlo Korhaz Teleph
city: Kfar Sava
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Hadassah Medical Center- Ein Kerem - PPDS
state: Yerushalayim
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - PPDS
city: Reggio Emilia
country: Italy
facility: AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova
state: Emilia-Romagna
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
state: Lazio
city: Milano
country: Italy
facility: ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
state: Piemonte
city: Catania
country: Italy
facility: AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
state: Veneto
city: Civitavecchia RM
country: Italy
facility: San Paolo Hospital Civitavecchia
city: Nagoya-Shi
country: Japan
facility: Chubu Rosai Hospital
state: Aiti
city: Nagoya-Shi
country: Japan
facility: Japan Community Health Care Organization (JCHO) Chukyo Hospital
state: Aiti
city: Nagoya
country: Japan
facility: Daido Clinic
state: Aiti
city: Sapporo-Shi
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Sapporo-Shi
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidô
city: Kita Kyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan
state: Hukuoka
city: Nishinomiya-Shi
country: Japan
facility: Hyogo Medical University Hospital
state: Hyôgo
city: Tsukuba-Shi
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kahoku-Shi
country: Japan
facility: Kanazawa Medical University Hospital
state: Isikawa
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Isikawa
city: Yokohama-Shi
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Kyoto-Shi
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
state: Kyôto
city: Kyoto-Shi
country: Japan
facility: Kyoto University Hospital
state: Kyôto
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Sasebo-Shi
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kurashiki-Shi
country: Japan
facility: Kurashiki Medical Clinic
state: Okayama
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Hamamatsu-city
country: Japan
facility: Hamamatsu University Hospital
state: Sizuoka
city: Bunkyo-Ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Chuo-Ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: Tokyo Medical Center
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St Mary's Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Mexicali
country: Mexico
facility: Centro de Investigación en Artritis y Osteoporosis - PPDS
state: Baja California
city: Parques De San Felipe
country: Mexico
facility: Mediadvance Clinical S.A.P.I. de C.V.
state: Chihuahua
city: Saltillo
country: Mexico
facility: ONCOR - Centro de Infusion e Investigación Oncologia de Saltillo S.C
state: Coahuila
city: Torreón Centro
country: Mexico
facility: CIMAB SA de CV
state: Coahuila
city: Ciudad de México
country: Mexico
facility: Cryptex Investigación Clínica, S.A. de C.V.
state: Distrito Federal
city: San Miguel Chapultepec
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica Y Clinica SC
state: Jalisco
city: Guadalajara
country: Mexico
facility: Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
state: Jalisco
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
state: Yucatán
city: Leon
country: Mexico
facility: Centro de Investigacion Farmacologica Del Bajio Sc
city: Mexico
country: Mexico
facility: Consultorio de Reumatologia
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Mitras Centro
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V. - PPDS
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization - Clinic - OSMO - PPDS
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials Ltd - PPDS
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials Trust
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Trujillo
country: Peru
facility: Centro de Investigacion Clinica Trujillo E.I.R.L.
state: La Libertad
city: San Juan de Lurigancho
country: Peru
facility: Clinica San Juan Bautista
state: Lima
city: Arequipa
country: Peru
facility: Hogar Clinica San Juan de Dios - Arequipa
city: Lima
country: Peru
facility: Hospital Militar Central Luis Arias Schereiber
city: Lima
country: Peru
facility: Clínica Internacional San Borja-Avenida Guardia Civil 385
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulacion S.A.C.
city: Lima
country: Peru
facility: Instituto de Ginecologia y Reproduccion - PPDS
city: Pueblo Libre
country: Peru
facility: Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej
state: Dolnoslaskie
city: Lublin
country: Poland
facility: ETG Lublin - PPDS
state: Lubelskie
city: Lublin
country: Poland
facility: Reumed Sp. z o.o. Poradnia Specjalistyczna Filia 2 Onyksowa
state: Lubelskie
city: Kraków
country: Poland
facility: Malopolskie Centrum Kliniczne
state: Malopolskie
city: Warszawa
country: Poland
facility: FutureMeds - Warszawa Centrum - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa - MICS - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by PRATIA - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Reuma Park sp . zoo Sp.k.
state: Mazowieckie
city: Warszawa
country: Poland
facility: FutureMeds - Targowek - PPDS
state: Mazowieckie
city: Wołomin
country: Poland
facility: K2J2 Medical Center
state: Mazowieckie
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: Med-Polonia Sp. z o.o.
state: Wielkopolskie
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Pawel Hrycaj
state: Wielkopolskie
city: Poznan
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola M
state: Wielkopolskie
city: Skórzewo
country: Poland
facility: Centrum Medyczne Poznan - PRATIA - PPDS
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: MICS Centrum Medyczne Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Ambulatorium Sp z o.o.
city: Katowice
country: Poland
facility: Centrum Medyczne Katowice - PRATIA - PPDS
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED- Olszanska 5G
city: Poznań
country: Poland
facility: Twoja Przychodnia PCM - ul. Marcelińska 92
city: Warszawa
country: Poland
facility: ETG Warszawa - PPDS
city: Warszawa
country: Poland
facility: WIM-PIB, Centralny Szpital Kliniczny MON
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
city: Wrocław
country: Poland
facility: Pracownia Badan Klinicznych Salus
city: Wrocław
country: Poland
facility: FutureMeds - Wroclaw - PPDS
city: Łódź
country: Poland
facility: FutureMeds - Lodz - PPDS
city: Lisbon
country: Portugal
facility: ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
state: Lisboa
city: Ponte de Lima
country: Portugal
facility: Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
state: Viana Do Castelo
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS
city: Vila Nova de Gaia
country: Portugal
facility: ULS de Gaia/Espinho, EPE - Unidade I
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC -62 Calle Jose Marti
city: Belgrade
country: Serbia
facility: Institute of Rheumatology - PPDS
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia - Pasterova 2 - PPDS
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Novi Sad
country: Serbia
facility: Special Hospital For Rheumatic Diseases Novi Sad
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Maribor
country: Slovenia
facility: University Clinical Centre Maribor
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital Civil
state: Málaga
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Castellón
country: Spain
facility: Hospital General Universitari de Castello
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Santa Coloma De Gramenet(Barcelona)
country: Spain
facility: Fundacio Hospital de l'Esperit Sant
city: Santa Cruz de Tenerife.
country: Spain
facility: Hospital Universitario Hospiten Rambla de Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quironsalud Infanta Luisa
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Vitoria
country: Spain
facility: Hospital Universitario Araba - Txagorritxu
state: Álava
city: Gui Shan Qu
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital - PPDS
city: Luton
country: United Kingdom
facility: Luton and Dunstable University Hospital
state: Bedfordshire
city: London
country: United Kingdom
facility: Royal Free Hospital
state: Camden
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital
city: London
country: United Kingdom
facility: William Harvey Research Institute
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: