A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX)
Arthritis, Psoriatic
About this trial
This is an interventional treatment trial for Arthritis, Psoriatic
Eligibility Criteria
Inclusion Criteria:
- Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
- 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 known allergies, hypersensitivity, or intolerance to study intervention or its excipients
- 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
Sites / Locations
- Rheumatology AssociatesRecruiting
- Arizona Arthritis and Rheumatology Research, PLLCRecruiting
- Arizona Arthritis & Rheumatology Associates PCRecruiting
- Arizona Arthritis & Rheumatology Research, PLLCRecruiting
- Advanced Medical ResearchRecruiting
- Rheumatology Center of San DiegoRecruiting
- Medvin Clinical Research, Inc.Recruiting
- Heuer M.D. ResearchRecruiting
- The Arthritis Center, Inc.
- Forcare Clinical Research, Inc.Recruiting
- Klein & Associates, M.D., P.A.Recruiting
- Advanced RheumatologyRecruiting
- Arthritis Consultants
- Glacier View Research InstituteRecruiting
- NYU Langone Ambulatory Care Brooklyn HeightsRecruiting
- PMG Research of SalisburyRecruiting
- STAT Research, Inc.Recruiting
- Altoona Center For Clinical ResearchRecruiting
- Dr. Ramesh GuptaRecruiting
- Austin Regional Clinic
- Adriana Pop Moody MD Clinic PARecruiting
- Southwest Rheumatology Research LLCRecruiting
- Arthritis & Osteoporosis ClinicRecruiting
- The Queen Elizabeth HospitalRecruiting
- Southern Clinical ResearchRecruiting
- Emeritus ResearchRecruiting
- Eastern Health - Box Hill HospitalRecruiting
- Rheumatology Research Unit
- University Clinical center Republic of SrpskaRecruiting
- Health center GradiskaRecruiting
- Clinical hospital MostarRecruiting
- Clinical Center University of SarajevoRecruiting
- UMHAT KaspelaRecruiting
- MHAT TrimantiumRecruiting
- Multiprofile Hospital for Active Treatment - PlovdivRecruiting
- Multiprofile Hosptal for Active Treatment Eurohospital PlovdivRecruiting
- Medical Center Unimed PlovdivRecruiting
- Medical Center TeodoraRecruiting
- Medical Center Medconsult-PlevenRecruiting
- UMHAT Sv. Ivan RilskiRecruiting
- UMHAT St. Ivan RilskiRecruiting
- DCC XVII-Sofia EOODRecruiting
- Medical Center Hera EOODRecruiting
- St Ivan Rilski University Multiprofile Hospital For Active TreatmentRecruiting
- DCC Convex EOODRecruiting
- Centre de Recherche Musculo SquelettiqueRecruiting
- Group De Recherche En Rhumatologie Et Maladies OsseusesRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- The First Affiliated Hospital of Baotou Medical UniversityRecruiting
- Peking University First HospitalRecruiting
- Peking University Third HospitalRecruiting
- Peking Union Medical College HospitalRecruiting
- The Affiliated Hospital of Bengbu Medical CollegeRecruiting
- The First Bethune Hospital of Jilin UniversityRecruiting
- Changzhou No.2 People's HospitalRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
- Guangzhou First Municipal People's HospitalRecruiting
- the 3rd Affiliated Hospital,Sun Yansen UniversityRecruiting
- The Affiliated Hospital of Guizhou Medical UniversityRecruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of MedicineRecruiting
- Linyi City People HospitalRecruiting
- The Second Affiliatde Hospital To Nanchang UniversityRecruiting
- The First Affiliated Hospital of NanChang UniversityRecruiting
- Pingxiang People's HospitalRecruiting
- Huashan Hospital Fudan UniversityRecruiting
- Shanghai skin disease hospitalRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- The hospital of Shanxi UniverstidyRecruiting
- Ch OsijekRecruiting
- KBC RijekaRecruiting
- University Hospital Center SplitRecruiting
- Klinicki bolnicki centar Zagreb
- Medicinski centar Kuna & PericRecruiting
- University Hospital Sveti DuhRecruiting
- Revmacentrum MUDr. Mostera, s.r.o.Recruiting
- RevmaclinicRecruiting
- Revmatologie s.r.o.Recruiting
- L.K.N ArthrocentrumRecruiting
- CCBR Ostrava, s.r.o.Recruiting
- MUDr. Rosypalova, s.r.oRecruiting
- CCBR Klinicka centra Czech, a.s.Recruiting
- Fakultni nemocnice v MotoleRecruiting
- Revmatologicka ambulanceRecruiting
- Revmatologicky institutRecruiting
- CCR Prague s.r.o.
- Affidea - Praha, s.r.o.Recruiting
- Medical Plus S.R.O.Recruiting
- PV-Medical S.R.ORecruiting
- OU InnomedicaRecruiting
- North Estonia Medical CentreRecruiting
- Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste KliinikRecruiting
- LTD Unimed AdjaraRecruiting
- LTD Clinic LJRecruiting
- Aleksandre Aladashvili Clinic LLCRecruiting
- Raymann LtdRecruiting
- J S C K Eristavi National CenRecruiting
- Tbilisi Heart and Vascular Clinic LtdRecruiting
- LTD MediClub GeorgiaRecruiting
- Consilium Medulla-multiprofile clinic LtdRecruiting
- Ltd MedicoreRecruiting
- Aleksandre Aladashvili Clinic LLCRecruiting
- JSC Evex HospitalsRecruiting
- LTD The First Medical CenterRecruiting
- Rheumatologische SchwerpunktpraxisRecruiting
- Hamburger Rheuma Forschungszentrum IIRecruiting
- Praxis fur Klinische Studien und Praxis fur OrthopadieRecruiting
- Rheumazentrum RuhrgebietRecruiting
- Institut Fur Praventive Medizin Klinische Forschung GbRRecruiting
- Rheumazentrum RatingenRecruiting
- Hippokration HospitalRecruiting
- Revita RendelőRecruiting
- Magyar Honvedseg Egeszsegugyi KozpontRecruiting
- Uno Medical Trials Ltd.Recruiting
- Qualiclinic KftRecruiting
- Debreceni Egyetem Klinikai KozpontRecruiting
- Synexus Magyarorszag KftRecruiting
- Pest Megyei Flor Ferenc KorhazRecruiting
- Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai KözpontRecruiting
- Csongrád Megyei Dr. Bugyi István KórházRecruiting
- MAV Korhaz es RendelointezetRecruiting
- Synexus Magyarorszag KftRecruiting
- Barzilai Medical CenterRecruiting
- Bnai Zion Medical CenterRecruiting
- Rambam Health Care CampusRecruiting
- Meir Medical CenterRecruiting
- Rabin Medical Center, Beilinson Campus
- The Chaim Sheba Medical CenterRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- AOU Università degli Studi della Campania L. VanvitelliRecruiting
- Azienda Ospedaliero Universitaria Policlinico Paolo GiacconeRecruiting
- Università di Roma La SapienzaRecruiting
- Complesso Integrato ColumbusRecruiting
- Soonchunhyang University Cheonan HospitalRecruiting
- Chonnam National University HospitalRecruiting
- Hanyang University HospitalRecruiting
- Asan Medical CenterRecruiting
- Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Ajou University HospitalRecruiting
- M & M Centrs LtdRecruiting
- P. Stradina Clinical University HospitalRecruiting
- Riga East Clinical University HospitalRecruiting
- Riga 1st HospitalRecruiting
- J Kisis LtdRecruiting
- Orto Clinic LtdRecruiting
- Practice Dr Pociene GilvinaRecruiting
- Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinikRecruiting
- Klaipeda University HospitalRecruiting
- Siauliai Republican Hospital, Public InstitutionRecruiting
- JSC Inlita, Santaros KTCRecruiting
- Hospital SelayangRecruiting
- Hospital Raja Permaisuri BainunRecruiting
- University Malaya Medical CentreRecruiting
- Hospital MelakaRecruiting
- Sunway Medical CentreRecruiting
- Hospital Tuanku JaafarRecruiting
- Angeles University Foundation Medical CenterRecruiting
- Cebu Doctors' University HospitalRecruiting
- De La Salle University Medical CenterRecruiting
- Davao Doctors HospitalRecruiting
- Southern Philippines Medical CenterRecruiting
- Manila Doctors HospitalRecruiting
- Medical Center ManilaRecruiting
- Philippine General HospitalRecruiting
- Osteo-Medic s.c A. Racewicz, J SupronikRecruiting
- ClinicMed Badurski i Wspolnicy Spolka JawnaRecruiting
- Nasz Lekarz Przychodnie MedyczneRecruiting
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w BydgoszczyRecruiting
- Ambulatorium Barbara BazelaRecruiting
- Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka PartnerskaRecruiting
- Medica Pro Familia sp. z o.o. S.K.A.Recruiting
- Pratia MCM KrakowRecruiting
- REUMED Zespol Poradni Specjalistycznych Filia nr 2Recruiting
- NZOZ Lecznica Mak-Med scRecruiting
- Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
- Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł HrycajRecruiting
- Nasz Lekarz Przychodnie MedyczneRecruiting
- Medycyna KlinicznaRecruiting
- Rheuma-Medicus, Zaklad Opieki ZdrowotnejRecruiting
- Reumatika-Centrum Reumatologii, NZOZRecruiting
- DERMMEDICA Sp.z o.o.Recruiting
- Chelyabinsk Regional Clinical Dermatovenerological DispensaryRecruiting
- LLC Aliance Biomedical-Ural group
- State Budgetary Educational Institution of High Professional EducationRecruiting
- Medical Center LLC Maxsimum ZdoroviyaRecruiting
- LLC Family Outpatient Clinic # 4Recruiting
- GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
- GU Moscow Regional Research Clinical Institute n.a. M.F.VlaRecruiting
- FGBU Research Institute of Rheumatology named V.A.Nasonova
- LLC Consultative and Diagnostic Center of Rheumatology HealRecruiting
- GBUZ Orenburg Clinical Regional HospitalRecruiting
- Republican Hospital n.a.V.A.Baranov
- Ryazan Regional Clinical Dermatovenerological DispensaryRecruiting
- Ryazan Regional Clinical Cardiology Center
- Ryazan Regional Clinical HospitalRecruiting
- LLC SanavitaRecruiting
- Sararov Regional Clinical Hospital
- Federal North-West Medical Research CentreRecruiting
- Northen-Western State Medical University n.a. I.I. Mechnikov
- Ulyanovsk Regional Clinical HospitalRecruiting
- State Budget Healthcare Institution of Vladimir Region Regional Clinical HospitalRecruiting
- Clinical Emergency Hospital n.a. N.V. SolovyevRecruiting
- Clinical Hospital #3Recruiting
- Institute of RheumatologyRecruiting
- Military Medical AcademyRecruiting
- Institute for Treatment and Rehabilitation Niska BanjaRecruiting
- Special Hospital for Rheumatic DiseasesRecruiting
- Paediatric University HospitalRecruiting
- Reumatologicka ambulanciaRecruiting
- Chiremed, s.r.o.Recruiting
- Reumex s.r.oRecruiting
- Splosna bolnisnica Izola
- Bolnica Dr. Petra DrzajaRecruiting
- UKC Maribor Dermatology clinicRecruiting
- Hosp. Univ. A CoruñaRecruiting
- Hosp. Reina SofiaRecruiting
- Hosp. Univ. 12 de OctubreRecruiting
- Hosp. Regional Univ. de MalagaRecruiting
- Hosp. Univ. Infanta SofiaRecruiting
- Complejo Hospitalario Universitario de Santiago. Servicio de Aparato DigestivoRecruiting
- Hosp. Nuestra Senora de La EsperanzaRecruiting
- Hosp. Clinico Univ. de SantiagoRecruiting
- Kaohsiung Veterans General HospitalRecruiting
- Chang Gung Medical FoundationRecruiting
- China Medical University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Linkou Chang Gung Memorial HospitalRecruiting
- Akdeniz University Medical FacultyRecruiting
- Kocaeli University Medical FacultyRecruiting
- Selcuk University Medical FacultyRecruiting
- Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
- Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoiRecruiting
- Municipal Institution Regional hospital-center of emergency care and disasters medicineRecruiting
- Khmelnitska oblasna likarniaRecruiting
- TOV Revmocentr
- Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi radyRecruiting
- Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company KyivmiskbudRecruiting
- State Institution Railway clinical Hospital 2Recruiting
- SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of UkraineRecruiting
- Olexandrivska Clinical Hospital of Kyiv CityRecruiting
- Kyivska oblasna klinichna likarnia
- Center of Family Medicine Plus LLCRecruiting
- Kyiv Railway Station Clinical Hospital #2
- Odeska oblasna klinichna likarnia
- Multidisciplinary Medical Center of Odessa National Medical UniversityRecruiting
- ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional ConsuilRecruiting
- Sumska oblasna klinichna likarniaRecruiting
- Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional CouncilRecruiting
- Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]Recruiting
- Medical Center LTD Health Clinic Department of Cardiology and RheumatologyRecruiting
- Zhytomyr Central City Hospital #1Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group 1: Guselkumab and Placebo
Group 2: Guselkumab
Group 3: Placebo Followed by Guselkumab
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.
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
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.