A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT ID: NCT04882098
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1054 participants
INTERVENTIONAL
2021-06-17
2028-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
Guselkumab
Participants will receive guselkumab as SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Group 2: Guselkumab
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Guselkumab
Participants will receive guselkumab as SC injection.
Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Guselkumab
Participants will receive guselkumab as SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Interventions
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Guselkumab
Participants will receive guselkumab as SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have \>= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
* Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Have active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis
Exclusion Criteria
* Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor
* Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Rheumatology Associates
Birmingham, Alabama, United States
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff, Arizona, United States
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Tucson, Arizona, United States
Advanced Medical Research
La Palma, California, United States
Rheumatology Center of San Diego
San Diego, California, United States
Medvin Clinical Research, Inc.
Whittier, California, United States
Heuer M.D. Research
Orlando, Florida, United States
The Arthritis Center, Inc.
Palm Harbor, Florida, United States
Forcare Clinical Research Inc
Tampa, Florida, United States
Klein And Associates M D P A
Hagerstown, Maryland, United States
Advanced Rheumatology
Lansing, Michigan, United States
Arthritis Consultants
St Louis, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
STAT Research, Inc.
Springboro, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Dr. Ramesh Gupta
Memphis, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Adriana Pop Moody MD Clinic PA
Corpus Christi, Texas, United States
Southwest Rheumatology Research LLC
Mesquite, Texas, United States
Arthritis And Osteoporosis Clinic
Waco, Texas, United States
The Queen Elizabeth Hospital
Adelaide, , Australia
Southern Clinical Research
Hobart, , Australia
Emeritus Research
Melbourne, , Australia
Eastern Health - Box Hill Hospital
Melbourne, , Australia
Rheumatology Research Unit
Sunshine Coast, , Australia
University Clinical center Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
Health center Gradiska
Gradiška, , Bosnia and Herzegovina
Clinical hospital Mostar
Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
UMHAT Kaspela
Plovdiv, , Bulgaria
MHAT Trimantium
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, , Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, , Bulgaria
Medical Center Unimed Plovdiv
Plovdiv, , Bulgaria
Medical Center Teodora
Rousse, , Bulgaria
Medical Center Medconsult-Pleven
Sevlievo, , Bulgaria
UMHAT Sv. Ivan Rilski
Sofia, , Bulgaria
UMHAT St. Ivan Rilski
Sofia, , Bulgaria
DCC XVII-Sofia EOOD
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
St Ivan Rilski University Multiprofile Hospital For Active Treatment
Sofia, , Bulgaria
DCC Convex EOOD
Sofia, , Bulgaria
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's, Newfoundland and Labrador, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Group De Recherche En Rhumatologie Et Maladies Osseuses
Québec, Quebec, Canada
Centre de Recherche Musculo Squelettique
Trois-Rivières, Quebec, Canada
Affiliated Hospital of Hebei University
Baoding, , China
The First Affiliated Hospital of Baotou Medical University
Baotou, , China
Peking University First Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
The Affiliated Hospital of Bengbu Medical College
Bengbu, , China
The First Bethune Hospital of Jilin University
Changchun, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
the 3rd Affiliated Hospital,Sun Yansen University
Guangzhou, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Linyi City People Hospital
Linyi, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Pingxiang People's Hospital
Pingxiang, , China
Huashan Hospital Fudan University
Shanghai, , China
Shanghai skin disease hospital
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
The hospital of Shanxi Universtidy
Taiyuan, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Ch Osijek
Osijek, , Croatia
KBC Rijeka
Rijeka, , Croatia
University Hospital Center Split
Split, , Croatia
Klinicki bolnicki centar Zagreb
Zagreb, , Croatia
Medicinski centar Kuna & Peric
Zagreb, , Croatia
University Hospital Sveti Duh
Zagreb, , Croatia
Revmaclinic
Brno, , Czechia
Revmatologie s r o
Brno, , Czechia
Revmacentrum MUDr Mostera s r o
Brno Zidenice, , Czechia
L K N Arthrocentrum
Hlučín, , Czechia
CCBR Ostrava s r o
Ostrava, , Czechia
MUDr Rosypalova s r o
Ostrava, , Czechia
CCBR Klinicka centra Czech, a.s.
Pardubice, , Czechia
Revmatologicky institut
Prague, , Czechia
CCR Prague s.r.o.
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Affidea Praha s r o
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Medical Plus S R O
Uherské Hradiště, , Czechia
PV Medical S R O
Zlín, , Czechia
OU Innomedica
Tallinn, , Estonia
North Estonia Medical Centre
Tallinn, , Estonia
Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
Tartu, , Estonia
LTD Unimed Adjara
Batumi, , Georgia
LTD Clinic LJ
Kutaisi, , Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
Raymann Ltd
Tbilisi, , Georgia
J S C K Eristavi National Cen
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, , Georgia
LTD MediClub Georgia
Tbilisi, , Georgia
Consilium Medulla-multiprofile clinic Ltd
Tbilisi, , Georgia
Ltd Medicore
Tbilisi, , Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
JSC Evex Hospitals
Tbilisi, , Georgia
LTD The First Medical Center
Tbilisi, , Georgia
Rheumatologische Schwerpunktpraxis
Berlin, , Germany
Hamburger Rheuma Forschungszentrum II
Hamburg, , Germany
Praxis fur Klinische Studien und Praxis fur Orthopadie
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Institut Fur Praventive Medizin Klinische Forschung GbR
Magdeburg, , Germany
Gemeinschaftspraxis Dres. Quist
Mainz, , Germany
Rheumazentrum Ratingen
Ratingen, , Germany
Naval Hospital of Athens
Athens, , Greece
Hippokration Hospital
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
University Hospital Of Larissa, Biopolis
Larissa, , Greece
Democritus University of Thrace
Xánthi, , Greece
Revita Rendelo
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Uno Medical Trials Ltd.
Budapest, , Hungary
Qualiclinic Kft
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Synexus Magyarorszag Kft
Gyula, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged, , Hungary
Csongrád Megyei Dr. Bugyi István Kórház
Szentes, , Hungary
MAV Korhaz es Rendelointezet
Szolnok, , Hungary
Synexus Magyarorszag Kft
Zalaegerszeg, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, , Italy
Ospedale San Raffaele, IRCCS
Milan, , Italy
AOU Università degli Studi della Campania L. Vanvitelli
Napoli, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Università di Roma La Sapienza
Roma, , Italy
Complesso Integrato Columbus
Rome, , Italy
A.O.U. Città della Salute e della Scienza
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
M & M Centrs Ltd
Ādaži, , Latvia
P. Stradina Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Riga 1st Hospital
Riga, , Latvia
J Kisis Ltd
Riga, , Latvia
Orto Clinic Ltd
Riga, , Latvia
Practice Dr Pociene Gilvina
Kaunas, , Lithuania
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, , Lithuania
JSC Inlita, Santaros KTC
Vilnius, , Lithuania
Hospital Selayang
Batu Caves, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Sunway Medical Centre
Petaling Jaya, , Malaysia
Hospital Tuanku Jaafar
Seremban, , Malaysia
Angeles University Foundation Medical Center
Angeles, , Philippines
Cebu Doctors' University Hospital
Cebu, , Philippines
De La Salle University Medical Center
Dasmariñas, , Philippines
Southern Philippines Medical Center
Davao City, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
University of Perpetual Help Dalta Medical Center, Inc
Las Piñas, , Philippines
Manila Doctors Hospital
Manila, , Philippines
Medical Center Manila
Manila, , Philippines
Philippine General Hospital
Manila, , Philippines
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , Poland
ClinicMed Badurski i Wspolnicy Spolka Jawna
Bialystok, , Poland
Nasz Lekarz Przychodnie Medyczne
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Ambulatorium Barbara Bazela
Elblag, , Poland
Medica Pro Familia sp z o o S K A
Gdynia, , Poland
Pratia MCM Krakow
Krakow, , Poland
REUMED Zespol Poradni Specjalistycznych Filia nr 2
Lublin, , Poland
NZOZ Lecznica Mak-Med sc
Nadarzyn, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj
Poznan, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Reumatika-Centrum Reumatologii, NZOZ
Warsaw, , Poland
DERMMEDICA Sp.z o.o.
Wroclaw, , Poland
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, , Russia
LLC Aliance Biomedical-Ural group
Izhevsk, , Russia
State Budgetary Educational Institution of High Professional Education
Kazan', , Russia
Medical Center LLC Maxsimum Zdoroviya
Kemerovo, , Russia
LLC Family Outpatient Clinic # 4
Moscow, , Russia
GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
Moscow, , Russia
GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
Moscow, , Russia
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow, , Russia
LLC Consultative and Diagnostic Center of Rheumatology Heal
Novosibirsk, , Russia
GBUZ Orenburg Clinical Regional Hospital
Orenburg, , Russia
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, , Russia
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, , Russia
Ryazan Regional Clinical Cardiology Center
Ryazan, , Russia
Ryazan Regional Clinical Hospital
Ryazan, , Russia
Northen-Western State Medical University n.a. I.I. Mechnikov
Saint Petersburg, , Russia
Federal North-West Medical Research Centre
Saint Petersburg, , Russia
LLC Sanavita
Saint Petersburg, , Russia
Sararov Regional Clinical Hospital
Saratov, , Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, , Russia
State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
Vladimir, , Russia
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , Russia
Clinical Hospital #3
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, , Serbia
Special Hospital for Rheumatic Diseases
Novi Sad, , Serbia
Paediatric University Hospital
Košice, , Slovakia
Reumatologicka ambulancia
Martin, , Slovakia
Chiremed, s.r.o.
Púchov, , Slovakia
Reumex s.r.o
Rimavská Sobota, , Slovakia
Splosna bolnisnica Izola
Izo, , Slovenia
Bolnica Dr. Petra Drzaja
Ljubljana, , Slovenia
UKC Maribor Dermatology clinic
Maribor, , Slovenia
Soonchunhyang University Cheonan Hospital
Cheonan-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hosp Univ A Coruna
A Coruña, , Spain
Hosp Reina Sofia
Córdoba, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. Univ. de Mostoles
Móstoles, , Spain
Hosp. Univ. Virgen de La Arrixaca
Murcia, , Spain
Hosp. Univ. Infanta Sofia
San Sebastián de los Reyes, , Spain
Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
Santiago de Compostela, , Spain
Hosp. Nuestra Senora de La Esperanza
Santiago de Compostela, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Virgen Macarena
Seville, , Spain
Hosp. Infanta Luisa
Seville, , Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taoyuan District, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Chi Mei Medical Center Yong Kang
Yung-Kang, , Taiwan
Akdeniz University Medical Faculty
Istanbul, , Turkey (Türkiye)
Izmir Katip Celebi University
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Selcuk University Medical Faculty
Konya, , Turkey (Türkiye)
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, , Ukraine
Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
Kharkiv, , Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, , Ukraine
Khmelnitska oblasna likarnia
Khmelnitsky, , Ukraine
TOV Revmocentr
Kiev, , Ukraine
Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
Kryvyi Rih, , Ukraine
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv, , Ukraine
State Institution Railway clinical Hospital 2
Kyiv, , Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, , Ukraine
Olexandrivska Clinical Hospital of Kyiv City
Kyiv, , Ukraine
Kyivska oblasna klinichna likarnia
Kyiv, , Ukraine
Center of Family Medicine Plus LLC
Kyiv, , Ukraine
Kyiv Railway Station Clinical Hospital #2
Kyiv, , Ukraine
Odeska oblasna klinichna likarnia
Odesa, , Ukraine
Multidisciplinary Medical Center of Odessa National Medical University
Odesa, , Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava, , Ukraine
Sumska oblasna klinichna likarnia
Sumy, , Ukraine
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
Ternopil, , Ukraine
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsia, , Ukraine
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
Vinnytsia, , Ukraine
Zhytomyr Central City Hospital #1
Zhytomyr, , Ukraine
Countries
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References
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Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Song J, Jiang Y, Shawi M, Kollmeier AP, Rahman P. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023 Jan 10;24(1):22. doi: 10.1186/s13063-022-06945-y.
Other Identifiers
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CNTO1959PSA3004
Identifier Type: OTHER
Identifier Source: secondary_id
2020-004981-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504734-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108957
Identifier Type: -
Identifier Source: org_study_id