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A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX)

Primary Purpose

Arthritis, Psoriatic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: Guselkumab and Placebo

Group 2: Guselkumab

Group 3: Placebo Followed by Guselkumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).

Secondary Outcome Measures

Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Number of Participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
Number of Participants with AEs leading to Discontinuation of Study Intervention
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Infections
Number of participants with infections will be reported.
Number of Participants with AEs Temporally Associated With an Injection-site Reactions
Number of participants with AEs temporally associated with an injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Number of participants with change from baseline in clinical laboratory abnormalities including hematology and chemistry will be reported.
Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Serum Guselkumab Concentration
Serum guselkumab concentration will be measured.
Number of Participants with Anti-guselkumab Antibodies
Number of participants with anti-guselkumab antibodies to guselkumab will be reported.

Full Information

First Posted
May 10, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04882098
Brief Title
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
Acronym
APEX
Official Title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
January 10, 2025 (Anticipated)
Study Completion Date
December 8, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab and Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Arm Title
Group 3: Placebo Followed by Guselkumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
CNTO 1959
Intervention Description
Participants will receive guselkumab as SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo as SC injection.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
Description
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
Description
Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
Time Frame
Baseline and Week 24
Title
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Description
Number of Participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
Time Frame
Up to 168 weeks
Title
Number of Participants with AEs leading to Discontinuation of Study Intervention
Description
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 168 weeks
Title
Number of Participants with Infections
Description
Number of participants with infections will be reported.
Time Frame
Up to 168 weeks
Title
Number of Participants with AEs Temporally Associated With an Injection-site Reactions
Description
Number of participants with AEs temporally associated with an injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time Frame
Up to 168 weeks
Title
Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Description
Number of participants with change from baseline in clinical laboratory abnormalities including hematology and chemistry will be reported.
Time Frame
Baseline, up to 168 weeks
Title
Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
Description
Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Time Frame
Up to 168 weeks
Title
Serum Guselkumab Concentration
Description
Serum guselkumab concentration will be measured.
Time Frame
Up to 168 weeks
Title
Number of Participants with Anti-guselkumab Antibodies
Description
Number of participants with anti-guselkumab antibodies to guselkumab will be reported.
Time Frame
Up to 168 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001-6218
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates PC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Medical Research
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Center of San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Individual Site Status
Recruiting
Facility Name
Medvin Clinical Research, Inc.
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Individual Site Status
Recruiting
Facility Name
Heuer M.D. Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
The Arthritis Center, Inc.
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Individual Site Status
Completed
Facility Name
Forcare Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Individual Site Status
Recruiting
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
Glacier View Research Institute
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901-3158
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Name
STAT Research, Inc.
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Individual Site Status
Recruiting
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Completed
Facility Name
Adriana Pop Moody MD Clinic PA
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Clinical Research
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Emeritus Research
City
Melbourne
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Recruiting
Facility Name
Eastern Health - Box Hill Hospital
City
Melbourne
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Rheumatology Research Unit
City
Sunshine Coast
ZIP/Postal Code
4558
Country
Australia
Individual Site Status
Completed
Facility Name
University Clinical center Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Health center Gradiska
City
Gradiska
ZIP/Postal Code
78400
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Clinical hospital Mostar
City
Mostar
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT Trimantium
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Unimed Plovdiv
City
Plovdiv
ZIP/Postal Code
4023
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Teodora
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Medconsult-Pleven
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Sv. Ivan Rilski
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT St. Ivan Rilski
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC XVII-Sofia EOOD
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
St Ivan Rilski University Multiprofile Hospital For Active Treatment
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DCC Convex EOOD
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Centre de Recherche Musculo Squelettique
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z1Y2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Group De Recherche En Rhumatologie Et Maladies Osseuses
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
ZIP/Postal Code
71030
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Baotou Medical University
City
Baotou
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100091
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233099
Country
China
Individual Site Status
Recruiting
Facility Name
The First Bethune Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Name
the 3rd Affiliated Hospital,Sun Yansen University
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
ZIP/Postal Code
551000
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Linyi City People Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliatde Hospital To Nanchang University
City
Nanchang
ZIP/Postal Code
330008
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
33006
Country
China
Individual Site Status
Recruiting
Facility Name
Pingxiang People's Hospital
City
Pingxiang
ZIP/Postal Code
337000
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai skin disease hospital
City
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110055
Country
China
Individual Site Status
Recruiting
Facility Name
The hospital of Shanxi Universtidy
City
Taiyuan
ZIP/Postal Code
30605
Country
China
Individual Site Status
Recruiting
Facility Name
Ch Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
KBC Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital Center Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Klinicki bolnicki centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Completed
Facility Name
Medicinski centar Kuna & Peric
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
University Hospital Sveti Duh
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Revmacentrum MUDr. Mostera, s.r.o.
City
Brno - Zidenice
ZIP/Postal Code
615 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmaclinic
City
Brno
ZIP/Postal Code
61141
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Individual Site Status
Recruiting
Facility Name
L.K.N Arthrocentrum
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCBR Ostrava, s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Rosypalova, s.r.o
City
Ostrava
ZIP/Postal Code
70800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCBR Klinicka centra Czech, a.s.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologicka ambulance
City
Praha 4
ZIP/Postal Code
14000
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologicky institut
City
Praha
ZIP/Postal Code
12850
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CCR Prague s.r.o.
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Individual Site Status
Completed
Facility Name
Affidea - Praha, s.r.o.
City
Praha
ZIP/Postal Code
14800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Medical Plus S.R.O.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
PV-Medical S.R.O
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Individual Site Status
Recruiting
Facility Name
OU Innomedica
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Individual Site Status
Recruiting
Facility Name
North Estonia Medical Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik
City
Tartu
ZIP/Postal Code
51013
Country
Estonia
Individual Site Status
Recruiting
Facility Name
LTD Unimed Adjara
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD Clinic LJ
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
01 02
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Raymann Ltd
City
Tbilisi
ZIP/Postal Code
0156
Country
Georgia
Individual Site Status
Recruiting
Facility Name
J S C K Eristavi National Cen
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi Heart and Vascular Clinic Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD MediClub Georgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Consilium Medulla-multiprofile clinic Ltd
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd Medicore
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Aleksandre Aladashvili Clinic LLC
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
JSC Evex Hospitals
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD The First Medical Center
City
Tbilisi
ZIP/Postal Code
180
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Rheumatologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hamburger Rheuma Forschungszentrum II
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Individual Site Status
Recruiting
Facility Name
Praxis fur Klinische Studien und Praxis fur Orthopadie
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Institut Fur Praventive Medizin Klinische Forschung GbR
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rheumazentrum Ratingen
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hippokration Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Revita Rendelő
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Uno Medical Trials Ltd.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Qualiclinic Kft
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Synexus Magyarorszag Kft
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Csongrád Megyei Dr. Bugyi István Kórház
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Individual Site Status
Recruiting
Facility Name
MAV Korhaz es Rendelointezet
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Synexus Magyarorszag Kft
City
Zalaegerszeg
ZIP/Postal Code
H-8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Completed
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
AOU Università degli Studi della Campania L. Vanvitelli
City
Napoli
ZIP/Postal Code
80128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00185
Country
Italy
Individual Site Status
Recruiting
Facility Name
Complesso Integrato Columbus
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan-si
ZIP/Postal Code
31151
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hospital
City
Gwangju-si
ZIP/Postal Code
501-757
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
M & M Centrs Ltd
City
Adazi
ZIP/Postal Code
LV-2164
Country
Latvia
Individual Site Status
Recruiting
Facility Name
P. Stradina Clinical University Hospital
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Riga East Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Riga 1st Hospital
City
Riga
ZIP/Postal Code
LV1001
Country
Latvia
Individual Site Status
Recruiting
Facility Name
J Kisis Ltd
City
Riga
ZIP/Postal Code
LV1003
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Orto Clinic Ltd
City
Riga
ZIP/Postal Code
LV1005
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Practice Dr Pociene Gilvina
City
Kaunas
ZIP/Postal Code
49476
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Siauliai Republican Hospital, Public Institution
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
JSC Inlita, Santaros KTC
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Melaka
City
Melaka
ZIP/Postal Code
75400
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sunway Medical Centre
City
Petaling Jaya, Selangor
ZIP/Postal Code
47500
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tuanku Jaafar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Angeles University Foundation Medical Center
City
Angeles
ZIP/Postal Code
2009
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Cebu Doctors' University Hospital
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
De La Salle University Medical Center
City
Dasmarinas
ZIP/Postal Code
4114
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Davao Doctors Hospital
City
Davao City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Southern Philippines Medical Center
City
Davao
ZIP/Postal Code
8000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Medical Center Manila
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Philippine General Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Osteo-Medic s.c A. Racewicz, J Supronik
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Recruiting
Facility Name
ClinicMed Badurski i Wspolnicy Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nasz Lekarz Przychodnie Medyczne
City
Bydgoszcz
ZIP/Postal Code
85-068
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ambulatorium Barbara Bazela
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medica Pro Familia sp. z o.o. S.K.A.
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia MCM Krakow
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
REUMED Zespol Poradni Specjalistycznych Filia nr 2
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Lecznica Mak-Med sc
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nasz Lekarz Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medycyna Kliniczna
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Rheuma-Medicus, Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Name
Reumatika-Centrum Reumatologii, NZOZ
City
Warszawa
ZIP/Postal Code
02-655
Country
Poland
Individual Site Status
Recruiting
Facility Name
DERMMEDICA Sp.z o.o.
City
Wroclaw
ZIP/Postal Code
51-318
Country
Poland
Individual Site Status
Recruiting
Facility Name
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Aliance Biomedical-Ural group
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
State Budgetary Educational Institution of High Professional Education
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Medical Center LLC Maxsimum Zdoroviya
City
Kemerovo
ZIP/Postal Code
644024
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Family Outpatient Clinic # 4
City
Moscow
ZIP/Postal Code
109044
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GU Moscow Regional Research Clinical Institute n.a. M.F.Vla
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
FGBU Research Institute of Rheumatology named V.A.Nasonova
City
Moscow
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
LLC Consultative and Diagnostic Center of Rheumatology Heal
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
GBUZ Orenburg Clinical Regional Hospital
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Republican Hospital n.a.V.A.Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Ryazan Regional Clinical Dermatovenerological Dispensary
City
Ryazan
ZIP/Postal Code
390000
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Ryazan Regional Clinical Cardiology Center
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
LLC Sanavita
City
Sankt-Petersburg.
ZIP/Postal Code
195257
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Sararov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Federal North-West Medical Research Centre
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Northen-Western State Medical University n.a. I.I. Mechnikov
City
St.-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Clinical Emergency Hospital n.a. N.V. Solovyev
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Clinical Hospital #3
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Institute for Treatment and Rehabilitation Niska Banja
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Special Hospital for Rheumatic Diseases
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Paediatric University Hospital
City
Kosice
ZIP/Postal Code
4011
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Reumatologicka ambulancia
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Chiremed, s.r.o.
City
Puchov
ZIP/Postal Code
020 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Reumex s.r.o
City
Rimavska Sobota
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Splosna bolnisnica Izola
City
Izo
ZIP/Postal Code
6310
Country
Slovenia
Individual Site Status
Completed
Facility Name
Bolnica Dr. Petra Drzaja
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
UKC Maribor Dermatology clinic
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. A Coruña
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Infanta Sofia
City
San Sebastián de los Reyes
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo
City
Santiago de Compostela
ZIP/Postal Code
15076
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Nuestra Senora de La Esperanza
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Akdeniz University Medical Faculty
City
Istanbul
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Selcuk University Medical Faculty
City
Konya
ZIP/Postal Code
42081
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Institution Regional hospital-center of emergency care and disasters medicine
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Khmelnitska oblasna likarnia
City
Khmelnitsky
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
TOV Revmocentr
City
Kiev
ZIP/Postal Code
04070
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady
City
Kryvyi Rih
ZIP/Postal Code
50056
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
State Institution Railway clinical Hospital 2
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Olexandrivska Clinical Hospital of Kyiv City
City
Kyiv
ZIP/Postal Code
1601
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Kyivska oblasna klinichna likarnia
City
Kyiv
ZIP/Postal Code
4107
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Center of Family Medicine Plus LLC
City
Kyiv
ZIP/Postal Code
4210
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Kyiv Railway Station Clinical Hospital #2
City
Kyiv
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Odeska oblasna klinichna likarnia
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Multidisciplinary Medical Center of Odessa National Medical University
City
Odessa
ZIP/Postal Code
65026
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Sumska oblasna klinichna likarnia
City
Sumy
ZIP/Postal Code
40031
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
City
Ternopil
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
City
Vinnytsya
ZIP/Postal Code
21009
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Zhytomyr Central City Hospital #1
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

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