A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Unity
A Phase 3 Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial With Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 Subcutaneous Administered by Prefilled Syringe in Adult Patients With Primary Sjögren's Disease
2 other identifiers
interventional
631
35 countries
281
Brief Summary
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD). The study consists of a double-blinded placebo-controlled treatment period and an open-label treatment period. The maximum study duration for participants in both study parts is approximately 105 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2025
Typical duration for phase_3
281 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 16, 2026
April 1, 2026
2.5 years
November 10, 2024
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in clinESSDAI score at week 48
The ESSDAI was designed to measure systemic disease activity in patients with PSjD and consists of 12 domains. The score varies between 0 (no disease activity) and 123 (max disease activity). The clinESSDAI includes all ESSDAI domains except the biological domain.
Up to 48 weeks
Secondary Outcomes (8)
Change from baseline in ESSDAI score at week 48
Up to 48 weeks
Proportion of participants with low disease activity (clinESSDAI < 5) at week 48
Up to 48 weeks
Proportion of responders on STAR (defined as ≥ 5 points) at week 48
Up to 48 weeks
Change from baseline in DiSSA joint pain item at week 48
Up to 48 weeks
Change from baseline in DiSSA total score at week 48
Up to 48 weeks
- +3 more secondary outcomes
Study Arms (3)
Double-blinded treatment period: Efgartigimod PH20 SC
EXPERIMENTALParticipants receiving efgartigimod PH20 SC during the double-blinded treatment period
Double-blinded treatment period: Placebo PH20 SC
PLACEBO COMPARATORParticipants receiving placebo PH20 SC during the double-blinded treatment period
Open-label treatment period
EXPERIMENTALParticipants receiving efgartigimod PH20 SC during the open-label treatment period
Interventions
subcutaneous efgartigimod PH20 SC given by prefilled syringe
subcutaneous placebo PH20 SC given by prefilled syringe
Eligibility Criteria
You may qualify if:
- Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- Meets the following criteria at screening: fulfilled ACR/EULAR classification criteria 2016 PSjD criteria before screening; clinESSDAI ≥ 6 at screening; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)
You may not qualify if:
- Secondary (also referred to as associated) Sjögren's disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy
- Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
- Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator's opinion.
- Use of cyclophosphamide ≤ 24 weeks prior to screening
- Anti-CD20 or anti-CD19 antibody received \< 6 months before screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (303)
One of a Kind Clinical Research Center LLC
Scottsdale, Arizona, 85258, United States
Arizona Arthritis & Rheumatology Research, PLLC
Sun City, Arizona, 85351, United States
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona, 85748, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309, United States
Finlay Medical Research Corp
Greenacres City, Florida, 33647, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, 32256, United States
Life Clinical Trials
Margate, Florida, 33063, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33606, United States
Conquest Research
Winter Park, Florida, 32789, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30318, United States
St. Luke's Clinic - Rheumatology
Boise, Idaho, 83702, United States
Chicago Clinical Research Institute
Chicago, Illinois, 60607, United States
Great Lakes Clinical Trials, LLC Ravenswood dba Flourish Research
Chicago, Illinois, 60640, United States
Chicago Arthritis & Regenerative Medicine
Chicago, Illinois, 60657, United States
Greater Chicago Specialty Physicians LLC
Orland Park, Illinois, 60467, United States
Arizona Arthritis & Rheumatology Research, PLLC
Willowbrook, Illinois, 60527, United States
Lake Cumberland Rheumatology
New Albany, Indiana, 47150, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, 70605, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21224, United States
Arthritis and Rheumatism Associates
Rockville, Maryland, 20850, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York, 11201, United States
Samaritan Health Services
Corvallis, Oregon, 97330, United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18105, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Allen Arthritis
Allen, Texas, 75013, United States
Accurate Clinical Management
Baytown, Texas, 77521, United States
Novel Research LLC
Bellaire, Texas, 77401, United States
Precision Comprehensive Clinical Research Solution
Colleyville, Texas, 76034-5913, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Arizona Arthritis & Rheumatology Research, PLLC
Fort Worth, Texas, 76109, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77089, United States
North Houston Arthritis Center
Houston, Texas, 77090, United States
Arizona Arthritis & Rheumatology Research, PLLC
Irving, Texas, 75039, United States
R and H Clinical Research
Katy, Texas, 77450, United States
Simcare Medical Research LLC
Sugar Land, Texas, 77478, United States
Velocity Clinical Research Waco
Waco, Texas, 76712, United States
Centro Medico Arsema
CABA, Buenos Aires, C1427CCL, Argentina
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Buenos Aires, B1878GEG, Argentina
Centro de Investigaciones San Miguel
San Miguel, Buenos Aires, 1663, Argentina
Sanatorio Parque S.A.
Rosario, Santa Fe Province, S2000DSV, Argentina
Instituto CAICI
Rosario, Santa Fe Province, S2000PBJ, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000BRD, Argentina
STAT Research S.A.
Buenos Aires, 1023, Argentina
Centro Medico Barrio Parque
Buenos Aires, 1425, Argentina
Consultorios Reumatologicos Pampa
Buenos Aires, C1125ABE, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
APRILLUS Asistencia e Investigacion
Buenos Aires, C1406AGA, Argentina
Westmead Hospital
Sydney, New South Wales, 2145, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Monash Medical Centre Clayton
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Rheuma-Zentrum Wien Oberlaa
Vienna, 1100, Austria
Erasme Hospital
Brussels, 1070, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
ReumaClinic
Genk, 3600, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
MC Artmed OOD
Plovdiv, 4002, Bulgaria
UMHAT "Pulmed" OOD
Plovdiv, 4002, Bulgaria
MHAT Dr Ivan Seliminski AD
Sliven, 8800, Bulgaria
DCC "Alexandrovska" EOOD
Sofia, 1431, Bulgaria
Applied Medical Informatics Research Inc.
Montreal, Quebec, H4A 3T2, Canada
CHUS - Hôtel-Dieu
Sherbrooke, Quebec, J1G 2E8, Canada
G.R.M.O Groupe De Recherche En Maladie Osseuses Inc
Québec, G1V 3M7, Canada
CTR Estudios
Santiago, 7500571, Chile
Enroll Spa
Santiago, 7500587, Chile
BioMedica Research Group
Santiago, 7500710, Chile
Centro de Estudios Reumatologicos
Santiago, 7501126, Chile
Centro Medico Prosalud
Santiago, 7510047, Chile
Clinical Research Chile SpA.
Valdivia, 5110683, Chile
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi Zhuang, 530021, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050066, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450008, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337055, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027, China
Jining No.1 People's Hospital
Jining, Shandong, 272011, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
Linyi People's Hospital
Linyi, Shandong, 276005, China
Linfen Central Hospital
Linfen, Shanxi, 041000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637001, China
Kunming Medical College Affiliated First Hospital
Kunming, Yun'Nan, 650032, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital
Beijing, 100730, China
Renji Hospital Shanghai Jiaotong University School of Medicine - West Branch
Shanghai, 200001, China
Huashan Hospital, Fudan University
Shanghai, 200040, China
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, 080002, Colombia
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, 080020, Colombia
Clinica de la Costa S.A.S
Barranquilla, 080020, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS. CIREEM
Bogotá, 110221, Colombia
BlueCare S.A.S
Bogotá, 111211, Colombia
Sociedad de Cirugia de Bogota Hospital de San Jose
Bogotá, 111411, Colombia
Servimed S.A.S.
Bucaramanga, 680003, Colombia
IPS Centro Medico Julian Coronel S.A.
Cali, 760035, Colombia
Servicios De Salud IPS Suramericana S A S Chipichape IPS
Cali, 760046, Colombia
Preventive Care Ltda
Chía, 250001, Colombia
Fundacion Oftalmologica de Santander - FOSCAL
Floridablanca, 681004, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Servicios De Salud IPS Suramericana S A S IPS Sura Industriales Medellin
Medellín, 50021, Colombia
Healthy Medical Center
Zipaquirá, 250252, Colombia
OÜ Innomedica
Tallinn, 10117, Estonia
Center for Clinical and Basic Research
Tallinn, 10128, Estonia
Meditrials
Tartu, 50708, Estonia
Hôpital Saint Joseph
Marseille, Bouches-du-Rhône, 13008, France
CHR Orléans
Orléans, Loiret, 45067, France
Hopital Edouard Herriot - CHU Lyon
Lyon, Rhone, 69437, France
Hôpital Lariboisière
Paris, 75010, France
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651, France
The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141, Georgia
Geo Hospitals LLC
Tbilisi, 0144, Georgia
VIAN
Tbilisi, 0159, Georgia
MediClub Georgia LLC
Tbilisi, 0160, Georgia
Clinic on Mtskheta Street
Tbilisi, 0179, Georgia
First Medical Center
Tbilisi, 0180, Georgia
Innova LLC
Tbilisi, 0186, Georgia
Universitaetsklinikum
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum der Universitaet Muenchen
Munich, Bavaria, 80336, Germany
HRF II - Hamburger Rheuma Forschungszentrum II
Hamburg, Free and Hanseatic City of Hamburg, 20095, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Euroclinic of Athens
Athens, 11521, Greece
NNA Hospital
Athens, 11521, Greece
General Hospital of Athens Laiko
Athens, 11527, Greece
University General Hospital Attikon
Chaïdári, 12462, Greece
General Hospital Papageorgiou
Thessaloniki, 56403, Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Bekes Varmegyei Kozponti Korhaz
Gyula, 5700, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632, Hungary
Vita Verum Medical
Székesfehérvár, 8000, Hungary
Clinical Research Ctr
Dublin, D04 T6F4, Ireland
Respiratory Depart Research
Dublin, D15X40D, Ireland
Barzilai Medical Center
Ashkelon, 7830604, Israel
The Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
Stabilimento Ospedaliero Santa Chiara
Pisa, 56100, Italy
Università Campus Bio-Medico di Roma - UOC Reumatologia
Roma, 00128, Italy
JCHO Chukyo Hospital
Nagoya, Aichi-ken, 457-8510, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Medical University Hospital
Nishinomiya-shi, Hyōgo, 663-8501, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Tohoku Medical and Pharmaceutical University Hospital
Sendai, Miyagi, 983-8536, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
Sasebo Chuo Hospital
Sasebo-shi, Nagasaki, 857-1195, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Shimane University Hospital
Izumo-shi, Shimane, 693-8501, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
St. Luke's International Hospital
Chūōku, Tokyo-To, 104-8560, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo-To, 173-8610, Japan
NHO Tokyo Medical Center
Meguro-ku, Tokyo-To, 152-8902, Japan
Keio University Hospital
Shinjuku-ku, Tokyo-To, 160-8582, Japan
The Specialty Hospital Advanced Clinical Center
Amman, 11194, Jordan
Jordan University Hospital
Amman, 11942, Jordan
Abdali Hospital
Amman, Jordan
Istiklal Hospital
Amman, Jordan
Pharmaceutical research center at Jordan University of Science and Technology
Irbid, 22110, Jordan
Irbid Specialty Hospital
Irbid, Jordan
Saint George Hospital University Medical Center
Beirut, 1100-2807, Lebanon
American University of Beirut
Beirut, 1107 2020, Lebanon
Hotel Dieu de France Hospital
Beirut, 166830, Lebanon
Ain Wazein Medical Village
El Shouf, 678002, Lebanon
Siauliai Republican Hospital
Šiauliai, LT-76231, Lithuania
Inlita, JSC, Center of Santaros Clinical Trials
Vilnius, LT-08406, Lithuania
Vilnius University Hospital
Vilnius, LT-08661, Lithuania
CIMAB SA de CV
Torreón, Coahuila, 27000, Mexico
CIMOVA (Consultorio anexo)
León, Guanajuato, 37000, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650, Mexico
Panamerican Clinical Research Mexico S.A. de C.V. Guadalajara
Guadalajara, Jalisco, 44670, Mexico
Centro de Estudios de Investigacion Basica y Clinica SC
Guadalajara, Jalisco, 44690, Mexico
Centro de investigacion medica y reumatologia
Guadalajara, Jalisco, 44950, Mexico
Consultorio Privado Dr. Miguel Cortes Hernandez
Cuernavaca, Morelos, 62448, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa SC
Culiacán, Sinaloa, 80000, Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, Yucatán, 97000, Mexico
Centro de Investigacion en Reumatologia
Mérida, Yucatán, 97070, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, 97070, Mexico
Investigacion y Biomedicina de Chihuahua, Sociedad Civil
Chihuahua City, 31000, Mexico
Centro de Investigacion y Atencion Integral Durango S.C.
Durango, 34080, Mexico
Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
Centro de Atención e Investigación Cardiovascular del Potosí, S.C.
San Luis Potosí City, 78200, Mexico
Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.
San Luis Potosí City, 78213, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Clinica El Golf
Lima, Peru
Clinica Internacional Sede San Borja
Lima, Peru
Hospital Nacional Cayetano Heredia
Lima, Peru
Ospital Ng Makati
City of Taguig, 1642, Philippines
Manila Doctors Hospital
Manila, 1000, Philippines
The Medical City
Ortigas, 1605, Philippines
St. Luke's Medical Center
Quezon City, 1112, Philippines
Nova Reuma
Bialystok, 15-707, Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065, Poland
Szpital Uniwersytecki nr 2 im.dr J. Biziela
Bydgoszcz, 85-168, Poland
Centrum Medyczne Intercor Sp. z o.o
Bydgoszcz, 85-605, Poland
Centrum Medyczne K2J2
Częstochowa, 42-202, Poland
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-217, Poland
Ambulatorium Sp z o o
Elblag, 82-300, Poland
FutureMeds Gdynia
Gdynia, 81-384, Poland
MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.
Grodzisk Mazowiecki, 05-825, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Malopolskie Badania Kliniczne
Krakow, 30-002, Poland
FutureMeds Krakow
Krakow, 31-501, Poland
SOMED CR
Lodz, 90-368, Poland
FutureMeds
Lodz, 91-363, Poland
Clinical Trials Umed Sp.z o.o
Lodz, 92-213, Poland
ETG Lublin
Lublin, 20-412, Poland
Reumed Spolka z o.o.
Lublin, 20-607, Poland
Provita Profamilia
Piotrkow Trybunalski, 97-300, Poland
Pratia Poznan
Poznan, 60-192, Poland
NSZOZ Termedica - Centrum Badan Klinicznych
Poznan, 60-681, Poland
Clinical Research Center Spółka z
Poznan, 61-731, Poland
ETG Siedlce
Siedlce, 08-110, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
ETG JustMed
Warsaw, 01-696, Poland
PRATIA S.A. MTZ Clinical Research Powered by Pratia
Warsaw, 02-172, Poland
Izabela Inglot Szczebiot
Warsaw, 02-637, Poland
Centrum Medyczne Reuma Park
Warsaw, 02-665, Poland
FutureMeds
Warsaw, 03-291, Poland
REUMA CENTRUM Specjalistyczna Praktyka Lekarska
Warsaw, 04-305, Poland
Centrum Medyczne K2J2
Wołomin, 05-200, Poland
FutureMeds
Wroclaw, 53-673, Poland
ETG Zamosc
Zamość, 22-400, Poland
Unidade Local de Saude de Coimbra
Coimbra, 3000-075, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
Hospital Conde de Bertiandos - Ponte de Lima (Unidade Local do Alto Minho, EPE)
Ponte de Lima, 4990-041, Portugal
Unidade Local de Saude de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L
Brasov, 500283, Romania
S.C Delta Health Care S.R.L
Bucharest, 014142, Romania
SC Aqua Med Consulting SRL
Constanța, 900612, Romania
King Faisal Specialist Hospital & Research Center
Riyadh, 11211, Saudi Arabia
King Saud University Medical City
Riyadh, 11472, Saudi Arabia
Institute of Rheumatology
Belgrade, 11000, Serbia
Special Hospital for Rheumatic Diseases
Novi Sad, 21000, Serbia
Artromac
Košice, 04011, Slovakia
MEDMAN s.r.o.
Martin, 03601, Slovakia
MEDMAN
Martin, 03601, Slovakia
Narodny ustav reumatickych chorob
Piešťany, 92112, Slovakia
ALBAMED
Zvolen, 96001, Slovakia
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Soonchunhyang University Seoul Hospital
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitario de Badajoz
Badajoz, Badajoz, 06080, Spain
Sanitas ES Sanitas Hospital CIMA
Barcelona, Barcelona, 08034, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Barcelona, 08035, Spain
Clinica GAIAS Santiago
Santiago de Compostela, La Coruña, 15702, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28031, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Studieenheten
Stockholm, 113 61, Sweden
Hopital Habib Thameur
Montfleury, 1008, Tunisia
EPS Hopital Mohamed Taher Maamouri
Nabeul, 8000, Tunisia
Hedi Chaker Hospital
Sfax, 3029, Tunisia
Hospital Farhat Hached
Sousse, 4000, Tunisia
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080, Turkey (Türkiye)
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Royal Hallamshire Hospital
Sheffield, West Midlands, S10 2JF, United Kingdom
Cannock Chase Hospital
Cannock, Staffordshire, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2024
First Posted
November 12, 2024
Study Start
January 15, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share