A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Phase 3

Recruiting

• Conditions: Sjögren's Syndrome (SS)
• Interventions: Drug: Dazodalibep; Drug: Placebo

• Registration Number: NCT06245408
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Study Start: 2024-04-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-09-02
• Study Completion: 2026-11-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 435

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dazodalibep Dose 1	Dazodalibep	Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.
Dazodalibep Dose 2	Dazodalibep	Participants will be administered dose 2 of dazodalibep by IV infusion.
Placebo	Placebo	Participants will be administered placebo by IV infusion.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Diary for Assessing Sjogren's Patient Reported Index (DASPRI ) score	At week 48
Change from baseline in ESSPRI score	At Week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total stimulated salivary flow	At Week 48
Proportion of participants achieving ESSPRI [1.5] response	At Week 48
Number of participants With Adverse Events of Special Interest (AESIs)	Baseline (Day 1) to Week 56
Proportion of participants achieving meaningful improvement in DASPRI	At Week 48
Change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue-Short Form 10a (PROMIS-Fatigue SF-10a)	At Week 48
Change from baseline in DASPRI Pain	At Week 48
Change from baseline in ESSPRI Pain	At Week 48
Change from baseline in ESSPRI fatigue domain score	At Week 48
Change from baseline in 36-item Short Form Survey (SF-36) Physical Component Summary (PCS) score	At Week 48
Change from baseline in DASPRI total score	At week 12 and week 24
Change from baseline in DASPRI Dryness	At Week 48
Change from baseline in ESSPRI Dryness	At Week 48
Change from baseline in ESSPRI total score	At week 12, Week 24
Change from baseline in DASPRI Fatigue	At Week 48
Number of participants With Treatment Emergent Adverse Events (TEAEs)	Baseline (Day 1) to Week 56
Number of participants With Treatment Emergent Serious Adverse Events (TESAEs)	Baseline (Day 1) to Week 56

Trial Locations

Locations (202)

Arizona Research Clinic PLLC; 🇺🇸 Chandler, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Flagstaff - 399 S Malpais Ln; 🇺🇸 Flagstaff, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Gilbert - 3645 S Rome St; 🇺🇸 Gilbert, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln; 🇺🇸 Glendale, Arizona, United States

Arizona Arthritis and Rheumatology Associates - Tucson - 2001 W Orange Grove Rd; 🇺🇸 Tucson, Arizona, United States

Samy Metyas MD Inc; 🇺🇸 Covina, California, United States

UCSD Altman Clinical and Translational Research Institute Building; 🇺🇸 La Jolla, California, United States

Inland Rheumatology Clinical Trials Incorporated; 🇺🇸 Upland, California, United States

Medvin Clinical Research; 🇺🇸 Whittier, California, United States

Tekton Research, LLC - 2121 E Harmony Rd - PPDS; 🇺🇸 Fort Collins, Colorado, United States

Bradenton Research Center Inc; 🇺🇸 Bradenton, Florida, United States

Clinical Research of West Florida Inc - Clearwater; 🇺🇸 Clearwater, Florida, United States

University of Miami - Leonard M. Miller School of Medicine; 🇺🇸 Miami, Florida, United States

West Broward Rheumatology Associates, Inc.; 🇺🇸 Tamarac, Florida, United States

BayCare Medical Group Primary Care and Rheumatology - Tampa; 🇺🇸 Tampa, Florida, United States

OrthoIllinois, LTD; 🇺🇸 Rockford, Illinois, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Tufts Medical Center - Rheumatology Research Office - PPDS; 🇺🇸 Boston, Massachusetts, United States

Shores Rheumatology; 🇺🇸 Saint Clair Shores, Michigan, United States

Kansas City Physician Partners-8350 N Saint Clair Ave; 🇺🇸 Kansas City, Missouri, United States

Arthritis, Rheumatic & Bone Disease Associates - P; 🇺🇸 Voorhees, New Jersey, United States

Albuquerque Center for Rheumatology; 🇺🇸 Albuquerque, New Mexico, United States

Duke Early Phase Clinical Research Unit; 🇺🇸 Durham, North Carolina, United States

Onsite Clinical Solutions, LLC - Salisbury; 🇺🇸 Salisbury, North Carolina, United States

Arthritis & Osteoporosis Center of Southwest Ohio - Miamisburg; 🇺🇸 Miamisburg, Ohio, United States

University of Toledo Medical Center; 🇺🇸 Toledo, Ohio, United States

STAT Research-600 Aviator Ct; 🇺🇸 Vandalia, Ohio, United States

Amarillo Center For Clinical Research - ClinEdge - PPDS; 🇺🇸 Amarillo, Texas, United States

Accurate Clinical Management-Baytown; 🇺🇸 Baytown, Texas, United States

Precision Comprehensive Clinical Research Solutions; 🇺🇸 Grapevine, Texas, United States

R & H Clinical Research-777 S Fry Rd; 🇺🇸 Katy, Texas, United States

Houston Rheumatology and Arthritis Specialists, PLLC; 🇺🇸 Katy, Texas, United States

Valley Arthritis Center; 🇺🇸 McAllen, Texas, United States

University of Texas - San Antonio - Health Science Center - PPDS; 🇺🇸 San Antonio, Texas, United States

Advanced Rheumatology of Houston; 🇺🇸 The Woodlands, Texas, United States

DM Clinical Research - Migraine and COPD - PPDS; 🇺🇸 Tomball, Texas, United States

Western Washington Medical Group; 🇺🇸 Bothell, Washington, United States

Rheumatology and Pulmonary Clinic; 🇺🇸 Beckley, West Virginia, United States

Sanatorio Agote - Swiss Medical Group - PPDS; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Guemes; 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Framingham Centro Médico; 🇦🇷 La Plata, Buenos Aires, Argentina

Instituto CER S.A.; 🇦🇷 Quilmes, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes SRL; 🇦🇷 Quilmes, Buenos Aires, Argentina

Hospital General de Agudos Dr. José María Ramos Mejia; 🇦🇷 Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Consultorios Médicos Dr. Doreski - PPDS; 🇦🇷 Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

Centro de Investigaciones Reumatológicas; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

Clínica Mayo de U.M.C.B. S.R.L; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

DOM Centro de Reumatología; 🇦🇷 Buenos Aires, Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Centro Medico Arsema; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Sanatorio Allende S.A; 🇦🇷 Córdoba, Argentina

Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan; 🇦🇷 San Juan, Argentina

The Queen Elizabeth Hospital; 🇦🇺 Woodville South, South Australia, Australia

UZ Gent; 🇧🇪 Gent, Belgium

SER - Serviços Especializados em Reumatologia da Bahia S/S - ME; 🇧🇷 Salvador, Bahia, Brazil

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras; 🇧🇷 Curitiba, Paraná, Brazil

LMK Servicos Medicos SS; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Centre de Recherche Musculo-Squelettique - 1920 Rue Bellefeuille; 🇨🇦 Trois-Rivières, Quebec, Canada

Clinical Research Chile SpA - PPDS; 🇨🇱 Valdivia, Los Ríos, Chile

BIOCINETIC Ltda; 🇨🇱 Peñalolén, Región-MetropolitanadeSantiago, Chile

Enroll SpA - Dr. Manuel Barros Borgono - PPDS; 🇨🇱 Santiago, Región-MetropolitanadeSantiago, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas; 🇨🇱 Vina del Mar, Valparaíso, Chile

Clinical Center Zagreb - Oncology - Salata 7 - PPDS; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Clinical Hospital Sveti Duh; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Poliklinika Bonifarm-Hondlova 2/10; 🇭🇷 Zagreb, Grad Zagreb, Croatia

Clinical Hospital Centre Osijek; 🇭🇷 Osijek, Croatia

University Hospital of Split-Spinciceva 1; 🇭🇷 Split, Croatia

Odense Universitets Hospital; 🇩🇰 Odense C, South Denmark, Denmark

CHU de Bordeaux - Hôpital Saint-André; 🇫🇷 Bordeaux, France

CHU de Brest - Hôpital La Cavale Blanche; 🇫🇷 Brest, France

Hopital Emile Muller; 🇫🇷 Mulhouse, France

AP-HP - Hôpital Saint Antoine; 🇫🇷 Paris, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

University Clinic Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Malopolskie Centrum Kliniczne; 🇵🇱 Kraków, Malopolskie, Poland

Rheumazentrum Prof. Dr. med. Gunther Neeck-Standort Bad Doberan; 🇩🇪 Bad Doberan, Mecklenburg-Vorpommern, Germany

Rheumazentrum Greifswald; 🇩🇪 Greifswald Hansestadt, Mecklenburg-Vorpommern, Germany

DRK Gemeinnützige Krankenhaus GmbH Sachsen - DRK Krankenhaus Chemnitz-Rabenstein; 🇩🇪 Chemnitz, Germany

MVZ Rheuma; 🇩🇪 Hamburg, Germany

Naval Hospital of Athens; 🇬🇷 Athina, Attiki, Greece

Laiko General Hospital of Athens; 🇬🇷 Athina, Attiki, Greece

General Hospital ''Asklepieio Voulas''; 🇬🇷 Voula, Attiki, Greece

University General Hospital of Larissa; 🇬🇷 Larissa, Larisa, Greece

Euromedica Kianous Stavros; 🇬🇷 Thessaloniki, Greece

Bekes Varmegyei Kozponti Korhaz; 🇭🇺 Gyula, Békés, Hungary

Vasarhelyi Sarkanyfu Kft.; 🇭🇺 Hódmezővásárhely, Csongrád, Hungary

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Szent Laszlo Korhaz Teleph; 🇭🇺 Budapest, Hungary

AUSL di Reggio Emilia - IRCCS - Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Emilia-Romagna, Italy

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia; 🇮🇹 Udine, Friuli-Venezia Giulia, Italy

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Lazio, Italy

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS; 🇮🇹 Roma, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Lombardia, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità; 🇮🇹 Novara, Piemonte, Italy

A.O.U. Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Piemonte, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Toscana, Italy

Azienda Ospedaliera Universitaria Integrata Di Verona; 🇮🇹 Verona, Veneto, Italy

AOU Policlinico Gaspare Rodolico-San Marco - Presidio Ospedaliero San Marco; 🇮🇹 Catania, Italy

ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini; 🇮🇹 Milano, Italy

Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara; 🇮🇹 Pisa, Italy

Chubu Rosai Hospital; 🇯🇵 Nagoya-Shi, Aiti, Japan

Japan Community Health Care Organization (JCHO) Chukyo Hospital; 🇯🇵 Nagoya-Shi, Aiti, Japan

Daido Clinic; 🇯🇵 Nagoya, Aiti, Japan

Sapporo Medical University Hospital; 🇯🇵 Sapporo-Shi, Hokkaidô, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo-Shi, Hokkaidô, Japan

Hospital of the University of Occupational and Environmental Health, Japan; 🇯🇵 Kita Kyushu-shi, Hukuoka, Japan

Hyogo Medical University Hospital; 🇯🇵 Nishinomiya-Shi, Hyôgo, Japan

University of Tsukuba Hospital; 🇯🇵 Tsukuba-Shi, Ibaraki, Japan

Kanazawa Medical University Hospital; 🇯🇵 Kahoku-Shi, Isikawa, Japan

Kanazawa University Hospital; 🇯🇵 Kanazawa-shi, Isikawa, Japan

National Hospital Organization Yokohama Medical Center; 🇯🇵 Yokohama-Shi, Kanagawa, Japan

University Hospital, Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto-Shi, Kyôto, Japan

Kyoto University Hospital; 🇯🇵 Kyoto-Shi, Kyôto, Japan

Nagasaki University Hospital; 🇯🇵 Nagasaki-shi, Nagasaki, Japan

Sasebo Chuo Hospital; 🇯🇵 Sasebo-Shi, Nagasaki, Japan

Kurashiki Medical Clinic; 🇯🇵 Kurashiki-Shi, Okayama, Japan

Saitama Medical University Hospital; 🇯🇵 Iruma-gun, Saitama, Japan

Hamamatsu University Hospital; 🇯🇵 Hamamatsu-city, Sizuoka, Japan

St. Luke's International Hospital; 🇯🇵 Chuo-Ku, Tokyo, Japan

Nihon University Itabashi Hospital; 🇯🇵 Itabashi, Tokyo, Japan

Tokyo Medical Center; 🇯🇵 Meguro-Ku, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

The Catholic University of Korea, Seoul St Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Centro de Investigación en Artritis y Osteoporosis - PPDS; 🇲🇽 Mexicali, Baja California, Mexico

Cryptex Investigación Clínica, S.A. de C.V.; 🇲🇽 Ciudad de México, Distrito Federal, Mexico

Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable - PPDS; 🇲🇽 Americana, Jalisco, Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC; 🇲🇽 Guadalajara, Jalisco, Mexico

Unidad de Atencion Medica e Investigacion en Salud; 🇲🇽 Merida, Mexico

Clinstile, S.A. de C.V.; 🇲🇽 Mexico, Mexico

Hospital Universitario Dr. Jose Eleuterio González; 🇲🇽 Mitras Centro, Mexico

Accelerium, S. de R.L. de C.V. - PPDS; 🇲🇽 Monterrey, Mexico

Optimal Clinical Trials Ltd - PPDS; 🇳🇿 Auckland, North Island, New Zealand

Aotearoa Clinical Trials Trust; 🇳🇿 Auckland, New Zealand

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Clinica San Juan Bautista; 🇵🇪 San Juan de Lurigancho, Lima, Peru

Hogar Clinica San Juan de Dios - Arequipa; 🇵🇪 Arequipa, Peru

Hospital Militar Central Luis Arias Schereiber; 🇵🇪 Lima, Peru

Clínica Internacional San Borja-Avenida Guardia Civil 385; 🇵🇪 Lima, Peru

Instituto Peruano del Hueso y la Articulacion S.A.C.; 🇵🇪 Lima, Peru

Instituto de Ginecologia y Reproduccion - PPDS; 🇵🇪 Lima, Peru

Alfredo Berrocal Kasay Reuma Sociedad de Responsabilidad Limitada; 🇵🇪 Pueblo Libre, Peru

Centro de Investigacion Clinica Trujillo EIRL; 🇵🇪 Trujillo, Peru

FutureMeds - Wroclaw - PPDS; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Centrum Medyczne Oporow; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Dolnoslaski Szpital Specjalistyczny im. T. Marciniaka, Centrum Medycyny Ratunkowej; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

ETG Lublin - PPDS; 🇵🇱 Lublin, Lubelskie, Poland

Reumed Sp. z o.o. Poradnia Specjalistyczna Filia 2 Onyksowa; 🇵🇱 Lublin, Lubelskie, Poland

FutureMeds - Warszawa Centrum - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

MICS Centrum Medyczne Warszawa - MICS - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

MTZ Clinical Research Powered by PRATIA - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher; 🇵🇱 Warszawa, Mazowieckie, Poland

Klinika Reuma Park sp . zoo Sp.k.; 🇵🇱 Warszawa, Mazowieckie, Poland

K2J2 Medical Center; 🇵🇱 Wolomin, Mazowieckie, Poland

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.; 🇵🇱 Malbork, Pomorskie, Poland

Med-Polonia Sp. z o.o.; 🇵🇱 Poznan, Wielkopolskie, Poland

Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego im. Karola M; 🇵🇱 Poznań, Wielkopolskie, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; 🇵🇱 Bydgoszcz, Poland

Ambulatorium Sp z o.o.; 🇵🇱 Elblag, Poland

Centrum Medyczne Katowice - PRATIA - PPDS; 🇵🇱 Katowice, Poland

Centrum Medyczne Plejady Magdalena Celinska - Lowenhoff, Michal Zolnowski Spolka komandytowa; 🇵🇱 Kraków, Poland

Twoja Przychodnia PCM - ul. Marcelińska 92; 🇵🇱 Poznań, Poland

WIM-PIB, Centralny Szpital Kliniczny MON; 🇵🇱 Warszawa, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu - Borowska 213; 🇵🇱 Wrocław, Poland

Pracownia Badan Klinicznych Salus; 🇵🇱 Wrocław, Poland

FutureMeds - Lodz - PPDS; 🇵🇱 Łódź, Poland

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz; 🇵🇹 Lisboa, Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E - PPDS; 🇵🇹 Lisboa, Portugal

Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima; 🇵🇹 Ponte De Lima, Portugal

ULS de Gaia/Espinho, EPE - Unidade I; 🇵🇹 Vila Nova de Gaia, Portugal

GCM Medical Group, PSC -62 Calle Jose Marti; 🇵🇷 San Juan, Puerto Rico

Institute of Rheumatology - PPDS; 🇷🇸 Belgrade, Serbia

Military Medical Academy; 🇷🇸 Belgrade, Serbia

University Clinical Center Kragujevac; 🇷🇸 Kragujevac, Serbia

Clinical Centre of Vojvodina; 🇷🇸 Novi Sad, Serbia

Special Hospital For Rheumatic Diseases Novi Sad; 🇷🇸 Novi Sad, Serbia

University Medical Centre Ljubljana-Vodnikova cesta 62; 🇸🇮 Ljubljana, Slovenia

University Clinical Centre Maribor; 🇸🇮 Maribor, Slovenia

C.H. Regional Reina Sofia - PPDS; 🇪🇸 Cordoba, Córdoba, Spain

Hospital Universitario de Basurto; 🇪🇸 Bilbao, Vizcaya, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario de Canarias; 🇪🇸 la Laguna, Spain

Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz - PPDS; 🇪🇸 Madrid, Spain

Fundacio Hospital de l'Esperit Sant; 🇪🇸 Santa Coloma De Gramenet(Barcelona), Spain

Hospital Universitario Hospiten Rambla de Tenerife; 🇪🇸 Santa Cruz de Tenerife., Spain

Hospital Quironsalud Infanta Luisa; 🇪🇸 Sevilla, Spain

Hospital Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain

Hospital Universitario Araba - Txagorritxu; 🇪🇸 Vitoria, Álava, Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

China Medical University Hospital - PPDS; 🇨🇳 Taichung City, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung City, Taiwan

Taipei Medical University Hospital - PPDS; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou; 🇨🇳 Taoyuan City, Taiwan

Royal Free Hospital; 🇬🇧 London, Camden, United Kingdom

Chapel Allerton Hospital; 🇬🇧 Leeds, United Kingdom

William Harvey Research Institute; 🇬🇧 London, United Kingdom