A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

Last updated: January 15, 2021
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Psoriatic Arthritis

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT03162796
CR108218
CNTO1959PSA3001
2016-001163-37
  • 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 3 swollen joints and at least 3 tender jointsat screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciLitre (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
  • 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 drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy :Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3months or evidence of intolerance; Apremilast therapy is defined as taking apremilastat the marketed dose approved in the country where the study is being conducted for atleast 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAIDfor at least 4 weeks or evidence of intolerance
  • Participants may have been previously treated with up to 2 anti-TNF (tumor necrosisfactor) alpha agents (approximately 30 percent [%] of the overall study population),and must document the reason for discontinuation

Exclusion

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of 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 ever received more than 2 anti-TNFalpha agents
  • Has previously received any biologic treatment (other than anti-TNF alpha agents),including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab,ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
  • Has previously received any systemic immunosuppressants (for example, azathioprine,cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea,tacrolimus) within 4 weeks of the first administration of study agent
  • Has received apremilast within 4 weeks prior to the first administration of studyagent
  • Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Study Design

Total Participants: 383
Study Start date:
August 24, 2017
Estimated Completion Date:
November 18, 2019

Study Description

This is a study of guselkumab in participants with active Psoriatic Arthritis (PsA) who had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms and the safety profile of guselkumab in the treatment of PsA. The study will consists of 4 phases: a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year (that is, 52 weeks), including a placebo controlled period from Week 0 to Week 24 and double-blind active treatment period from Week 24 to Week 52, and a safety follow-up phase of 8 weeks after Week 52 (Week 52 to 60) and will be 12 weeks from the last administration of study agent (at Week 48) to the final safety follow-up visit. Efficacy, safety, pharmacokinetic, immunogenicity, and biomarker evaluations will be performed in the study at defined schedule.

Connect with a study center

  • Barwon Rheumatology Services

    Geelong, 3220
    Australia

    Site Not Available

  • Southern Clinical Research

    Hobart, 7000
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, 2170
    Australia

    Site Not Available

  • Rheumatology Research Unit

    Maroochy Waters, 4558
    Australia

    Site Not Available

  • Rheumatology Research Unit

    Maroochydore, 4558
    Australia

    Site Not Available

  • Eastern Health - Box Hill Hospital

    Melbourne, 3128
    Australia

    Site Not Available

  • Queen Elizabeth Hospital

    Woodville, 5085
    Australia

    Site Not Available

  • Queen Elizabeth Hospital

    Woodville South, 5011
    Australia

    Site Not Available

  • Eastern Regional Health Authority, St. Clare's Mercy Hospital

    St. John's, Newfoundland and Labrador A1C 5B8
    Canada

    Site Not Available

  • The Waterside Clinic

    Barrie, Ontario L4M 6L2
    Canada

    Site Not Available

  • Dermatrials Research

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • Skin Centre for Dermatology

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • K. Papp Clinical Research

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

    Quebec, G1V 3M7
    Canada

    Site Not Available

  • Revmaclinic

    Brno, 61141
    Czechia

    Site Not Available

  • MUDr. Rosypalova, s.r.o

    Ostrava, 70800
    Czechia

    Site Not Available

  • Revmatologicky ustav

    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

  • ISA GmbH

    Berlin, 10789
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • MVZ Rheuma

    Hamburg, 20095
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, 44649
    Germany

    Site Not Available

  • Krankenhaus St. Josef

    Wuppertal, 42105
    Germany

    Site Not Available

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062
    Hungary

    Site Not Available

  • Orszagos Reumatologia es Fizioterapias Intezet

    Budapest, 1023
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • Martinus Medicus Health Center

    Szombathely, 9700
    Hungary

    Site Not Available

  • Seoul National University Bundang Hospital

    Bundang, 13620
    Korea, Republic of

    Site Not Available

  • Hanyang University Hospital for rheumatic Diseases

    Seoul, 04763
    Korea, Republic of

    Site Not Available

  • SMG - SNU Boramae Medical Center

    Seoul, 7061
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Site Not Available

  • Hospital Selayang

    Batu Caves, 68100
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Georgetown, 10990
    Malaysia

    Site Not Available

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990
    Malaysia

    Site Not Available

  • Hospital Melaka

    Melaka, 75400
    Malaysia

    Site Not Available

  • Hospital Tuanku Jaafar

    Seremban, 70300
    Malaysia

    Site Not Available

  • Nzoz Osteo-Medic

    Bialystok, 15-351
    Poland

    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 J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

    Elblag, 82-300
    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

  • Nasz Lekarz Przychodnie Medyczne

    Torun, 87-100
    Poland

    Site Not Available

  • Medycyna Kliniczna

    Warsaw, 00-874
    Poland

    Site Not Available

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

    Warszawa, 02-637
    Poland

    Site Not Available

  • Centrum Medyczne WroMedica

    Wroclaw, 51-685
    Poland

    Site Not Available

  • Nzoz Biogenes Sp. Z O. O.

    Wroclaw, 53-224
    Poland

    Site Not Available

  • Biogenes Sp. z o. o.

    Wrocław, 53-224
    Poland

    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 for Minimal Money'

    Kemerovo, 650056
    Russian Federation

    Site Not Available

  • Kirov State Medical Academy

    Kirov, 610027
    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

  • 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

  • City Clinical Hospital # 26

    St-Petersburg, 196247
    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

  • 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. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Regional Carlos Haya

    Málaga, 29009
    Spain

    Site Not Available

  • Hosp. de Merida

    Mérida, 06800
    Spain

    Site Not Available

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208
    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. de Manises

    Valencia, 46940
    Spain

    Site Not Available

  • Hosp. Mexoeiro

    Vigo, 36200
    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

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 402
    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

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Chang-Gung Memorial Hospital, LinKou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • Municipal health care institution Chernihiv Regional Hospital

    Chernihiv,
    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

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

    Kharkiv,
    Ukraine

    Site Not Available

  • Khmelnitckiy regional hospital

    Khmelnytsky,
    Ukraine

    Site Not Available

  • City Clinical Hospital No. 2

    Kryvyi Rih, 50056
    Ukraine

    Site Not Available

  • Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'

    Kyiv,
    Ukraine

    Site Not Available

  • Kyiv Railway Station Clinical Hospital #2

    Kyiv,
    Ukraine

    Site Not Available

  • Danylo Halytsky Lviv National Medical University

    Lviv,
    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 institution of Tepnopil Regional Council 'Ternopil University Hospital'

    Ternopil,
    Ukraine

    Site Not Available

  • Transcarpathian Regional Clinical Hospital

    Uzhgorod,
    Ukraine

    Site Not Available

  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

    Vinnytsya, 21009
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Clinical Hospital

    Zaporizhzhya,
    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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