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)
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- Have a diagnosis of Psoriatic Arthritis (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 at least 3 tender joints at 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 of plaque 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 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance - Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuationExclusion Criteria:
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (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 study agent - Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX‑509), or any other Janus kinase (JAK) inhibitorTrial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03162796 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Janssen Research & Development, LLC |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Janssen Research & Development, LLC Clinical Trial |
| Principal Investigator Affiliation | Janssen Research & Development, LLC |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Canada, Czechia, Germany, Hungary, Korea, Republic of, Malaysia, Poland, Russian Federation, Spain, Taiwan, Ukraine, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Arthritis, Psoriatic |
| Study Website: | View Trial Website |
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Rheumatology Associates
Birmingham, Alabama, 35205
Site Contact
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, 85306
Site Contact
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210
Site Contact
Status
Recruiting
Address
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810
Site Contact
Status
Completed
Address
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256-4697
Site Contact
Status
Withdrawn
Address
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Site Contact
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Site Contact
Status
Recruiting
Address
Arthritis Consultants
Saint Louis, Missouri, 63141
Site Contact
Status
Recruiting
Address
Arthritis and Osteoporosis Associates
Freehold, New Jersey, 07728
Site Contact
Status
Recruiting
Address
Austin Regional Clinic
Austin, Texas, 78731-3146
Site Contact
International Sites
Status
Active, not recruiting
Address
Skin Centre for Dermatology
Peterborough, Ontario, K9J 5K2
Site Contact
Status
Recruiting
Address
Eastern Health - Box Hill Hospital
Melbourne, , 3128
Site Contact
Status
Recruiting
Address
Queen Elizabeth Hospital
Woodville South, , 5011
Site Contact
Status
Recruiting
Address
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John'S, Newfoundland and Labrador, A1C 5B8
Site Contact
Status
Active, not recruiting
Address
The Waterside Clinic
Barrie, Ontario, L4M 6L2
Site Contact
Status
Recruiting
Address
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
Site Contact
Status
Recruiting
Address
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec, , G1V 3M7
Site Contact
Status
Withdrawn
Address
Charite - Universitatsmedizin Berlin (CCM)
Berlin, , 10117
Site Contact
Status
Recruiting
Address
Universitatsklinikum Frankfurt
Frankfurt, , 60590
Site Contact
Status
Active, not recruiting
Address
Orszagos Reumatologia es Fizioterapias Intezet
Budapest, , 1023
Site Contact
Status
Active, not recruiting
Address
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , 1062
Site Contact
Status
Active, not recruiting
Address
Debreceni Egyetem Klinikai Kozpont
Debrecen, , 4032
Site Contact
Status
Active, not recruiting
Address
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , 2143
Site Contact
Status
Active, not recruiting
Address
Martinus Medicus Health Center
Szombathely, , 9700
Site Contact
Status
Recruiting
Address
Seoul National University Bundang Hospital
Bundang, , 13620
Site Contact
Status
Withdrawn
Address
Seoul National University Hospital
Seoul, , 03080
Site Contact
Status
Recruiting
Address
Hanyang University Hospital for rheumatic Diseases
Seoul, , 04763
Site Contact
Status
Recruiting
Address
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , 06591
Site Contact
Status
Active, not recruiting
Address
Hospital Selayang
Batu Caves, , 68100
Site Contact
Status
Active, not recruiting
Address
Pulau Pinang Hospital
Georgetown, , 10990
Site Contact
Status
Active, not recruiting
Address
Hospital Raja Permaisuri Bainun
Ipoh, , 30990
Site Contact
Status
Active, not recruiting
Address
Hospital Tuanku Jaafar
Seremban, , 70300
Site Contact
Status
Active, not recruiting
Address
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok, , 15-351
Site Contact
Status
Active, not recruiting
Address
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, , 85-168
Site Contact
Status
Active, not recruiting
Address
Centrum Kliniczno Badawcze
Elblag, , 82-300
Site Contact
Status
Active, not recruiting
Address
Etyka Osrodek Badan Klinicznych
Olsztyn, , 10-117
Site Contact
Status
Active, not recruiting
Address
Centrum Medyczne Hetmańska
Poznań, , 60-218
Site Contact
Status
Active, not recruiting
Address
Nasz Lekarz, Nzoz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodn
Torun, , 87-100
Site Contact
Status
Active, not recruiting
Address
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa, , 02-637
Site Contact
Status
Active, not recruiting
Address
Centrum Medyczne WroMedica
Wroclaw, , 51-685
Site Contact
Status
Active, not recruiting
Address
Biogenes Sp. z o. o.
Wrocław, , 53-224
Site Contact
Status
Recruiting
Address
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, , 454092
Site Contact
Status
Recruiting
Address
Medical and Sanitary Unit "Severstal"
Cherepovets, , 162600
Site Contact
Status
Recruiting
Address
Research Institute of Dermatovenerology, Immunology
Ekaterinburg, , 620076
Site Contact
Status
Recruiting
Address
Krasnoyarsk State Medical University
Krasnoyarsk, , 660022
Site Contact
Status
Recruiting
Address
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, , 398005
Site Contact
Status
Recruiting
Address
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, , 344007
Site Contact
Status
Recruiting
Address
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, , 390046
Site Contact
Status
Withdrawn
Address
Saratov Regional Clinical Hospital
Saratov, , 410053
Site Contact
Status
Recruiting
Address
Republican Clinical Hospital - G.G. Kuvatov
Ufa, , 450005
Site Contact
Status
Recruiting
Address
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , 150003
Site Contact
Status
Completed
Address
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , 28007
Site Contact
Status
Recruiting
Address
Hosp. Clinico Univ. de Santiago
Santiago De Compostela, , 15706
Site Contact
Status
Active, not recruiting
Address
Kaohsiung Veterans General Hospital
Kaohsiung, , 81362
Site Contact
Status
Completed
Address
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung, , 833
Site Contact
Status
Active, not recruiting
Address
Chung Shan Medical University Hospital
Taichung, , 402
Site Contact
Status
Active, not recruiting
Address
National Cheng Kung University Medical Center
Tainan, , 704
Site Contact
Status
Active, not recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Site Contact
Status
Active, not recruiting
Address
Chang Kung Memorial Hospital
Taipei, , 105
Site Contact
Status
Active, not recruiting
Address
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, , 333
Site Contact
Status
Withdrawn
Address
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, , 18009
Site Contact
Status
Recruiting
Address
Municipal health care institution Chernihiv Regional Hospital
Chernihiv, ,
Site Contact
Status
Recruiting
Address
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ivano-Frankivsk, ,
Site Contact
Status
Recruiting
Address
Communal Institution of Health Kharkiv City multifield hospital №18
Kharkiv, , 61029
Site Contact
Status
Withdrawn
Address
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv, , 61029
Site Contact
Status
Recruiting
Address
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, ,
Site Contact
Status
Withdrawn
Address
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, ,
Site Contact
Status
Recruiting
Address
Kyiv Railway Station Clinical Hospital #2
Kyiv, ,
Site Contact
Status
Withdrawn
Address
SI National Scientific Center The M.D.Strazhesko Institute of Cardiology of NAMSU
Kyiv, ,
Site Contact
Status
Recruiting
Address
SI National Scientific Center The M.D.Strazhesko Institute of Cardiology of NAMSU
Kyiv, ,
Site Contact
Status
Recruiting
Address
Danylo Halytsky Lviv National Medical University
Lviv, ,
Site Contact
Status
Recruiting
Address
State Institution Odesa Regional Clinical Hospital
Odessa, ,
Site Contact
Status
Withdrawn
Address
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava, ,
Site Contact
Status
Recruiting
Address
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, ,
Site Contact
Status
Withdrawn
Address
Transcarpathian Regional Clinical Hospital
Uzhgorod, ,
Site Contact
Status
Withdrawn
Address
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsya, , 21009
Site Contact
Status
Withdrawn
Address
Vinnytsya State Medical University, Vinnytsya Regional Clinical Hospital
Vinnytsya, ,
Site Contact
Status
Withdrawn
Address
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, ,
Site Contact
