A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Last updated: December 20, 2022
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT03158285
CR108219
2016-001224-63
CNTO1959PSA3002
  • Ages > 18
  • All Genders

Study Summary

The primary 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the firstadministration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
  • Have active PsA as defined by: at least 5 swollen joints and at least 5 tender jointsat screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram perdeciLitre (mg/dL) at screening from the central laboratory
  • Have at least 1 of the PsA subsets: distal interphalangeal joint involvement,polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans,asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locallyperformed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI jointx-ray or pelvic magnetic resonance imaging (MRI) has been previously performed.Results must be documented)
  • Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history ofplaque psoriasis
  • Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

Exclusion

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations or benefit ofguselkumab therapy, including but not limited to rheumatoid arthritis (RA), axialspondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis),systemic lupus erythematosus, or Lyme disease
  • Has previously received any biologic treatment
  • Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
  • Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4weeks of the first administration of study agent
  • Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX],sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but notlimited to chloroquine, gold preparations, and penicillamine within 4 weeks before thefirst administration of study agent
  • Has received apremilast within 4 weeks prior to the first administration of studyagent

Study Design

Total Participants: 741
Study Start date:
July 12, 2017
Estimated Completion Date:
November 10, 2020

Study Description

This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.

Connect with a study center

  • Multiprofile Hospital for Active Treatment - Plovdiv

    Plovdiv, 4003
    Bulgaria

    Site Not Available

  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Medical Center Teodora

    Ruse, 7003
    Bulgaria

    Site Not Available

  • Diagnostic Consulting Center No 17

    Sofia, 1505
    Bulgaria

    Site Not Available

  • Medical Centre Synexus

    Sofia, 1794
    Bulgaria

    Site Not Available

  • Military Medical Academy

    Sofia, 1606
    Bulgaria

    Site Not Available

  • MHAT-Targovishte, AD

    Targovishte, 7700
    Bulgaria

    Site Not Available

  • Revmaclinic

    Brno, 61141
    Czechia

    Site Not Available

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno - Zidenice, 615 00
    Czechia

    Site Not Available

  • MUDr. Rosypalova, s.r.o

    Ostrava, 70800
    Czechia

    Site Not Available

  • Revmatologicky institut

    Praha, 12850
    Czechia

    Site Not Available

  • Revmatologicka ambulance

    Praha 4, 14000
    Czechia

    Site Not Available

  • Medical Plus S.R.O.

    Uherske Hradiste, 68601
    Czechia

    Site Not Available

  • PV-Medical S.R.O

    Zlin, 76001
    Czechia

    Site Not Available

  • Parnu Hospital

    Parnu, 80010
    Estonia

    Site Not Available

  • East Tallinn Central Hospital

    Tallinn, 11312
    Estonia

    Site Not Available

  • OU Innomedica

    Tallinn, 10117
    Estonia

    Site Not Available

  • Clinical Research Centre

    Tartu, 50106
    Estonia

    Site Not Available

  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • 'Agios Andreas' General Hospital of Patras

    Patra, 263 35
    Greece

    Site Not Available

  • University General Hospital of Rio Patras

    Patras, 26500
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "Agios Pavlos"

    Thessaloniki, 55134
    Greece

    Site Not Available

  • Daugavpils Regional Hospital

    Daugavpils, LV5417
    Latvia

    Site Not Available

  • Derma Clinic Riga

    Riga, LV1003
    Latvia

    Site Not Available

  • J Kisis Ltd

    Riga, LV1003
    Latvia

    Site Not Available

  • Orto Clinic Ltd

    Riga, LV1005
    Latvia

    Site Not Available

  • S.Saleniece Private Practice

    Valmiera, LV-4201
    Latvia

    Site Not Available

  • Vakk, Jsc

    Kaunas, LT50128
    Lithuania

    Site Not Available

  • Siauliai Republican Hospital, Public Institution

    Siauliai, LT-76231
    Lithuania

    Site Not Available

  • Central Outpatient Clinic

    Vilnius, LT01117
    Lithuania

    Site Not Available

  • National Osteoporosis Centre

    Vilnius, LT09310
    Lithuania

    Site Not Available

  • Hospital Selayang

    Batu Caves, 68100
    Malaysia

    Site Not Available

  • Pulau Pinang Hospital

    Georgetown, 10990
    Malaysia

    Site Not Available

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, Sarawak
    Malaysia

    Site Not Available

  • Hospital Melaka

    Melaka, 75400
    Malaysia

    Site Not Available

  • Hospital Putrajaya

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Hospital Tuanku Jaafar

    Seremban, 70300
    Malaysia

    Site Not Available

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • NSZOZ Unica CR

    Dabrowka, 62-069
    Poland

    Site Not Available

  • Centrum Kliniczno Badawcze

    Elblag, 82-300
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    Gdansk, 80-546
    Poland

    Site Not Available

  • Centrum Badań Klinicznych PI-House sp. z o.o.

    Gdańsk, 80-546
    Poland

    Site Not Available

  • Szpital Specjalistyczny im. J. Dietla

    Krakow, 31-121
    Poland

    Site Not Available

  • Centrum Badawcze Wspolczesnej Terapii

    Lodz, 90-242
    Poland

    Site Not Available

  • Centrum Medyczne AMED oddzial w Lodzi

    Lodz, 91-363
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED. S.C.

    Nadarzyn, 05-830
    Poland

    Site Not Available

  • Etyka Osrodek Badan Klinicznych

    Olsztyn, 10-117
    Poland

    Site Not Available

  • Centrum Medyczne Hetmańska

    Poznań, 60-218
    Poland

    Site Not Available

  • Wojewódzki Zespół reumatologiczny im J.Titz-Kosko

    Sopot, 81-759
    Poland

    Site Not Available

  • Lubelskie Centrum Diagnostyczne

    Swidnik, 21-040
    Poland

    Site Not Available

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87-100
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warsaw, 00-874
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warsawa, 00-660
    Poland

    Site Not Available

  • Centrum Medyczne AMED Warszawa Targowek

    Warszawa, 03-291
    Poland

    Site Not Available

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

    Warszawa, 02-637
    Poland

    Site Not Available

  • Wromedica

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Biogenes Sp. z o. o.

    Wrocław, 53-224
    Poland

    Site Not Available

  • Hospital Garcia de Orta, EPE

    Almada, 2805-267
    Portugal

    Site Not Available

  • Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro

    Aveiro, 3814-501
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • ULSAM, EPE - Hospital Conde de Bertiandos

    Ponte De Lima, 4990-078
    Portugal

    Site Not Available

  • Spitalul Clinic Sf. Maria

    Bucharest, 11172
    Romania

    Site Not Available

  • Spitalul clinic judetean de urgenta Cluj

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • Spitalul Clinic de Recuperare Iasi

    Iasi, 700656
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Targu-Mures, 540132
    Romania

    Site Not Available

  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary

    Chelyabinsk, 454092
    Russian Federation

    Site Not Available

  • Medical and Sanitary Unit ''Severstal''

    Cherepovets, 162600
    Russian Federation

    Site Not Available

  • Research Institute of Dermatovenerology, Immunology

    Ekaterinburg, 620076
    Russian Federation

    Site Not Available

  • Medical Centre Maximum Health

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital for War Veterans

    Kemerovo, 650000
    Russian Federation

    Site Not Available

  • Family polyclinic #4

    Korolev, 141060
    Russian Federation

    Site Not Available

  • Krasnodar Clinical Dermatovenerologic Dispensary

    Krasnodar, 350020
    Russian Federation

    Site Not Available

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022
    Russian Federation

    Site Not Available

  • Lipetsk Regional Dermatovenerological Dispensary

    Lipetsk, 398005
    Russian Federation

    Site Not Available

  • Moscow State Medical and Stomatological University

    Moscow, 111398
    Russian Federation

    Site Not Available

  • Clinical Diagnostic Center 'Ultramed'

    Omsk, 644024
    Russian Federation

    Site Not Available

  • Orenburg State Medical University

    Orenburg, 460000
    Russian Federation

    Site Not Available

  • Republican Hospital n.a.V.A.Baranov

    Petrozavodsk, 185019
    Russian Federation

    Site Not Available

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov, 344007
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390046
    Russian Federation

    Site Not Available

  • Saratov Regional Clinical Hospital

    Saratov, 410053
    Russian Federation

    Site Not Available

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025
    Russian Federation

    Site Not Available

  • City Clinic №25 - City Rheumatology Centre

    St-Petersburg, 190068
    Russian Federation

    Site Not Available

  • Leningrad region clinical hospital

    St-Petersburg, 194291
    Russian Federation

    Site Not Available

  • Siberian State Medical University

    Tomsk, 634050
    Russian Federation

    Site Not Available

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, 300053
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital

    Tver, 170036
    Russian Federation

    Site Not Available

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005
    Russian Federation

    Site Not Available

  • Clinical Emergency Hospital n.a. N.V. Solovyev

    Yaroslavl, 150003
    Russian Federation

    Site Not Available

  • Clinical Hospital #10

    Yaroslavl, 150023
    Russian Federation

    Site Not Available

  • Clinical Hospital #3

    Yaroslavl, 150007
    Russian Federation

    Site Not Available

  • Panorama Medical Centre

    Cape Town, 7500
    South Africa

    Site Not Available

  • Clinresco Centres Ltd

    Kemptonpark, 1619
    South Africa

    Site Not Available

  • Arthritis Clinical Research Centre

    Pinelands, 7405
    South Africa

    Site Not Available

  • Dr Breedt Emmed Research

    Pretoria, 0002
    South Africa

    Site Not Available

  • Winelands Rheumatology Centre

    Stellenbosch, 7600
    South Africa

    Site Not Available

  • Hosp. Univ. A Coruña

    A Coruna, 15006
    Spain

    Site Not Available

  • Hosp. Gral. Univ. de Alicante

    Alicante, 0-3010
    Spain

    Site Not Available

  • Hosp. Univ. de Cruces

    Barakaldo, 48903
    Spain

    Site Not Available

  • Hosp. Del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hosp. Univ. de Basurto

    Bilbao, 48013
    Spain

    Site Not Available

  • Hosp. Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hosp. Univ. de Getafe

    Getafe, 28905
    Spain

    Site Not Available

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hosp. Regional. Carlos Haya

    Málaga, 29009
    Spain

    Site Not Available

  • Hosp. de Merida

    Mérida, 06800
    Spain

    Site Not Available

  • H.U. Infanta Sofía

    San Sebastián de los Reyes, 28702
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Hosp. Unv. de Valme

    Sevilla, 414014
    Spain

    Site Not Available

  • Hosp. Univ. Dr. Peset

    Valencia, 46017
    Spain

    Site Not Available

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hosp. Do Meixoeiro

    Vigo, 36214
    Spain

    Site Not Available

  • Hualien Tzu Chi Hospital

    Hualien City, 970
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital Kaohsiung Branch

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • National Cheng Kung University Medical Center

    Tainan, 704
    Taiwan

    Site Not Available

  • Chang Kung Memorial Hospital

    Taipei, 105
    Taiwan

    Site Not Available

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Ankara Bilkent City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Hacettepe University Medical Faculty

    Ankara, 6100
    Turkey

    Site Not Available

  • Akdeniz University Medical Faculty

    Antalya, 7059
    Turkey

    Site Not Available

  • Uludag University Medical Faculty

    Bursa, 16059
    Turkey

    Site Not Available

  • Osmangazi University Medical Faculty

    Eskisehir, 26480
    Turkey

    Site Not Available

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147
    Turkey

    Site Not Available

  • Marmara University Medical Faculty

    Istanbul, 34899
    Turkey

    Site Not Available

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340
    Turkey

    Site Not Available

  • Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital

    Izmir, 35360
    Turkey

    Site Not Available

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • Municipal health care institution Chernihiv Regional Hospital

    Chernihiv, 14029
    Ukraine

    Site Not Available

  • Ukrainian State Scientific And Research Institute Of Medical And Social Problems Of Disablement

    Dnipro, 61029
    Ukraine

    Site Not Available

  • Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

    Ivano-Frankivsk,
    Ukraine

    Site Not Available

  • Communal Institution of Health Kharkiv City multifield hospital №18

    Kharkiv, 61029
    Ukraine

    Site Not Available

  • Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'

    Kharkiv, 61029
    Ukraine

    Site Not Available

  • Municipal Institution Regional hospital-center of emergency care and disasters medicine

    Kharkiv,
    Ukraine

    Site Not Available

  • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

    Kharkiv, 61039
    Ukraine

    Site Not Available

  • Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

    Kherson, 73000
    Ukraine

    Site Not Available

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000
    Ukraine

    Site Not Available

  • City Clinical Hospital No. 2

    Kryvyi Rih, 50056
    Ukraine

    Site Not Available

  • Kyiv City Clinical Hospital #3

    Kyiv, 02125
    Ukraine

    Site Not Available

  • Kyiv Railway Station Clinical Hospital #2

    Kyiv,
    Ukraine

    Site Not Available

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107
    Ukraine

    Site Not Available

  • Medical Center 'Consylium Medical'

    Kyiv, 04050
    Ukraine

    Site Not Available

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv,
    Ukraine

    Site Not Available

  • Danylo Halytsky Lviv National Medical University

    Lviv,
    Ukraine

    Site Not Available

  • Lviv Communcal City Clinical Hospital #4

    Lviv,
    Ukraine

    Site Not Available

  • Multidisciplinary Medical Center of Odessa National Medical University

    Odessa, 65026
    Ukraine

    Site Not Available

  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

    Odessa, 65025
    Ukraine

    Site Not Available

  • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

    Poltava,
    Ukraine

    Site Not Available

  • Sumy State University

    Sumy,
    Ukraine

    Site Not Available

  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

    Ternopil,
    Ukraine

    Site Not Available

  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil, 46002
    Ukraine

    Site Not Available

  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

    Vinnytsya, 21009
    Ukraine

    Site Not Available

  • VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

    Vinnytsya,
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Clinical Hospital

    Zaporizhzhya,
    Ukraine

    Site Not Available

  • Municipal institution Central Clinical Hospital #1 Zhytomir

    Zhytomir, 10002
    Ukraine

    Site Not Available

  • Municipal institution Central Clinical Hospital #1 Zhytomir

    Zhytomyr, 10002
    Ukraine

    Site Not Available

  • Rheumatology Associates

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Associates PC

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Clinical Research Center of Connecticut

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46256-4697
    United States

    Site Not Available

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Arthritis Consultants

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • Austin Regional Clinic

    Austin, Texas 78731-3146
    United States

    Site Not Available

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