Clinical trial NCT06245408: A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
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 Symptom State (HZNP-DAZ-303)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sjögren's Syndrome (SS)
Keywords: 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: 2024-02-07
Enrollment: 435
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 patient-reported symptoms of SS in participants with moderate-to-severe symptom state

Secondary Objectives:

1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS.
2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS
3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Detailed description: Acquired from Horizon in 2024.

Eligibility criteria: Key Inclusion Criteria:

1. Diagnosed with SS by meeting the 2016 ACR/EULAR Classification Criteria
2. Have an ESSPRI score of ≥ 5 at screening.
3. Have an ESSDAI score of \< 5 at screening.
4. Positive for either anti-Ro autoantibodies or RF, or both at screening (as per the definition of the standard central laboratory test).
5. Residual salivary gland function as defined by whole stimulated salivary flow \> 0.1 mL/min.
6. Vaccinated against SARS-CoV-2 according to current local authority guidelines at least 2 weeks prior to screening unless participant refuses vaccination.
7. Meets all of the following tuberculosis (TB) criteria:

   1. No history of latent or active TB prior to screening, except for latent TB with documented completion of locally appropriate treatment.
   2. No signs or symptoms suggestive of active TB from medical history or physical examination.
   3. No recent (≤ 12 weeks of screening) close contact with a person with active TB (close contact is defined as ≥ 4 hours/week OR living in the same household OR in a house where a person with active TB is a frequent visitor).
   4. Negative Interferon Gamma Release Assay (IGRA) test result for TB at screen unless previously treated as per Inclusion Criterion. Participants with an indeterminate test result can repeat the test, but if the repeat test is also indeterminate, they are excluded.
   5. A chest radiograph (obtained during the screening period or any time within 12 weeks prior to screening) with no evidence of current active TB or other infection, or prior TB, malignancy, or clinically significant abnormalities suggesting an active process (unless due to SS).

Key Exclusion Criteria:

1. Individuals with medical history of confirmed deep venous thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
2. History or presence of concomitant polymyositis or dermatomyositis or systemic sclerosis.
3. Active malignancy or history of malignancy within the last 5 years, except as follows:

   1. In situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR
   2. Cutaneous basal cell carcinoma following presumed curative therapy.
4. Individuals who are pregnant or lactating or planning to become pregnant during the study.
5. Individuals with known history of severe allergy or reaction to any component of the IP formulation or to any other biologic therapy.
6. Individuals with any severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder or any other condition that, in the opinion of the Investigator, 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.
7. Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis c or HIV infection.
8. Individuals with a positive test for SARS-CoV-2 on the day of randomization or symptoms suggestive of SARS-CoV-2 at randomization or significant exposure to coronavirus disease 2019 (COVID-19) within 10 calendar days prior to randomization.
9. Individuals with:

   1. A history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity.
   2. Active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring IV antibiotics within 12 months prior to screening.

Primary outcomes:
measure: Change from baseline in ESSPRI score
timeFrame: At Week 48
measure: Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score
timeFrame: At week 48
Secondary outcomes:
measure: Proportion of participants achieving meaningful improvement in DASPRI
timeFrame: At Week 48
measure: Proportion of participants achieving ESSPRI [1.5] response
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 DASPRI Dryness
timeFrame: At Week 48
measure: Change from baseline in ESSPRI Dryness
timeFrame: At Week 48
measure: Change from baseline in DASPRI Pain
timeFrame: At Week 48
measure: Change from baseline in ESSPRI Pain
timeFrame: At Week 48
measure: Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score
timeFrame: At Week 48
measure: Change from baseline in DASPRI total score
timeFrame: At week 12 and week 24
measure: Change from baseline in ESSPRI total score
timeFrame: At week 12, Week 24
measure: Change from baseline in DASPRI Fatigue
timeFrame: At Week 48
measure: Change from baseline in ESSPRI fatigue domain 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: Baseline (Day 1) to Week 56
measure: Number of participants With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline (Day 1) to Week 56
Other outcomes:
Locations:
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: Covina
country: United States
facility: Samy Metyas MD Inc
state: California
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: Whittier
country: United States
facility: Medvin Clinical Research
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: Miami
country: United States
facility: University of Miami - Leonard M. Miller School of Medicine
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group Primary Care and Rheumatology - Tampa
state: Florida
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: Boston
country: United States
facility: Tufts Medical Center - Rheumatology Research Office - PPDS
state: Massachusetts
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: Voorhees
country: United States
facility: Arthritis, Rheumatic & Bone Disease Associates - P
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
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: Amarillo
country: United States
facility: Amarillo Center For Clinical Research - ClinEdge - 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: Katy
country: United States
facility: R & H Clinical Research-777 S Fry Rd
state: Texas
city: Katy
country: United States
facility: Houston Rheumatology and Arthritis Specialists, PLLC
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: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Migraine and COPD - PPDS
state: Texas
city: Bothell
country: United States
facility: Western Washington Medical Group
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: 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: Consultorios Médicos Dr. Doreski - PPDS
state: Ciudad Autónoma De BuenosAires
city: San Miguel De Tucumán
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: Córdoba
country: Argentina
facility: Sanatorio Allende S.A
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
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-Rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille
state: Quebec
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA - PPDS
state: Los Ríos
city: Peñalolén
country: Chile
facility: BIOCINETIC Ltda
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: Enroll SpA - Dr. Manuel Barros Borgono - PPDS
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: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Saint-André
city: Brest
country: France
facility: CHU de Brest - Hôpital La Cavale Blanche
city: Mulhouse
country: France
facility: Hopital Emile Muller
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: 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: 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: 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: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Di Verona
state: Veneto
city: Catania
country: Italy
facility: AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco
city: Milano
country: Italy
facility: ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
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: 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: Mexicali
country: Mexico
facility: Centro de Investigación en Artritis y Osteoporosis - PPDS
state: Baja California
city: Ciudad de México
country: Mexico
facility: Cryptex Investigación Clínica, S.A. de C.V.
state: Distrito Federal
city: Americana
country: Mexico
facility: Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica Y Clinica SC
state: Jalisco
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Mitras Centro
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio González
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V. - PPDS
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials Ltd - PPDS
state: North Island
city: Auckland
country: New Zealand
facility: Aotearoa Clinical Trials Trust
city: Hamilton
country: New Zealand
facility: Waikato Hospital
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: Trujillo
country: Peru
facility: Centro de Investigacion Clinica Trujillo EIRL
city: Wroclaw
country: Poland
facility: FutureMeds - Wroclaw - PPDS
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
state: Dolnoslaskie
city: Wroclaw
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: Wolomin
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: Poznań
country: Poland
facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola M
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: 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: Poznań
country: Poland
facility: Twoja Przychodnia PCM - ul. Marcelińska 92
city: Warszawa
country: Poland
facility: WIM-PIB, Centralny Szpital Kliniczny MON
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213
city: Wrocław
country: Poland
facility: Pracownia Badan Klinicznych Salus
city: Łódź
country: Poland
facility: FutureMeds - Lodz - PPDS
city: Lisboa
country: Portugal
facility: ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS
city: Ponte De Lima
country: Portugal
facility: Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
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: 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-Vodnikova cesta 62
city: Maribor
country: Slovenia
facility: University Clinical Centre Maribor
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: la Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
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: 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: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital - PPDS
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital - PPDS
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
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
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: