A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
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 |
|
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 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 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 (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed.
Exclusion Criteria:
- Has other inflammatory diseases that might confound the evaluations or 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 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, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks 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 not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent - Has received apremilast within 4 weeks prior to the first administration of study agentTrial 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. |
NCT03158285 |
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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 |
|
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 |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Bulgaria, Czechia, Estonia, Latvia, Lithuania, Malaysia, Poland, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States |
|
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 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.
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
Completed
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
Withdrawn
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
Multiprofile Hospital for Active Treatment - Plovdiv
Plovdiv, , 4003
Site Contact
Status
Active, not recruiting
Address
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, , 4004
Site Contact
Status
Active, not recruiting
Address
Medical Center 'Teodora'
Ruse, , 7003
Site Contact
Status
Active, not recruiting
Address
Diagnostic Consulting Center No 17
Sofia, , 1505
Site Contact
Status
Active, not recruiting
Address
Military Medical Academy
Sofia, , 1606
Site Contact
Status
Active, not recruiting
Address
Medical Centre Synexus
Sofia, , 1794
Site Contact
Status
Active, not recruiting
Address
MHAT-Targovishte, AD
Targovishte, , 7700
Site Contact
Status
Recruiting
Address
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, , 615 00
Site Contact
Status
Active, not recruiting
Address
East Tallinn Central Hospital
Tallinn, , 11312
Site Contact
Status
Active, not recruiting
Address
Clinical Research Centre
Tartu, , 50106
Site Contact
Status
Recruiting
Address
Daugavpils Regional Hospital
Daugavpils, , LV5417
Site Contact
Status
Withdrawn
Address
Riga East Clinical University Hospital
Riga, , LV1038
Site Contact
Status
Active, not recruiting
Address
Siauliai Republican Hospital, Public Institution
Siauliai, , LT-76231
Site Contact
Status
Active, not recruiting
Address
Central Outpatient Clinic
Vilnius, , LT01117
Site Contact
Status
Withdrawn
Address
Vilnius University Hospital Santariskiu Clinics
Vilnius, , LT08661
Site Contact
Status
Active, not recruiting
Address
National Osteoporosis Centre
Vilnius, , LT09310
Site Contact
Status
Withdrawn
Address
UAB Centre for Clinical Basic Research
Vilnius, , LT10323
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
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdańsk, , 80-546
Site Contact
Status
Completed
Address
Centrum Badawcze Wspolczesnej Terapii
Lodz, , 90-242
Site Contact
Status
Active, not recruiting
Address
Centrum Medyczne AMED oddzial w Lodzi
Lodz, , 91-363
Site Contact
Status
Active, not recruiting
Address
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , 05-830
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
Lubelskie Centrum Diagnostyczne
Swidnik, , 21-040
Site Contact
Status
Active, not recruiting
Address
Nasz Lekarz, Nzoz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodn
Torun, , 87-100
Site Contact
Status
Completed
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 AMED Warszawa Targowek
Warszawa, , 03-291
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
Regional Clinical Hospital for War Veterans
Kemerovo, , 650000
Site Contact
Status
Recruiting
Address
Medical Centre 'Maximum Health'
Kemerovo, , 650066
Site Contact
Status
Recruiting
Address
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar, , 350020
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
Moscow State Medical and Stomatological University
Moscow, , 111398
Site Contact
Status
Recruiting
Address
Clinical Diagnostic Center 'Ultramed'
Omsk, , 644024
Site Contact
Status
Recruiting
Address
Orenburg State Medical University
Orenburg, , 460000
Site Contact
Status
Recruiting
Address
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, , 185019
Site Contact
Status
Recruiting
Address
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, , 344007
Site Contact
Status
Withdrawn
Address
GBOU VPO Ryazan State Medical University n.a. Academic I.P. Pavlov
Ryazan, , 390026
Site Contact
Status
Recruiting
Address
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, , 390046
Site Contact
Status
Recruiting
Address
Saratov Regional Clinical Hospital
Saratov, , 410053
Site Contact
Status
Recruiting
Address
Smolensk regional hospital on Smolensk railway station
Smolensk, , 214025
Site Contact
Status
Recruiting
Address
City Clinic №25 - City Rheumatology Centre
St-Petersburg, , 190068
Site Contact
Status
Recruiting
Address
Leningrad region clinical hospital
St-Petersburg, , 194291
Site Contact
Status
Withdrawn
Address
Siberian State Medical University
Tomsk, , 634050
Site Contact
Status
Recruiting
Address
Tula Regional Clinical Dermatovenerological Dispensary
Tula, , 300053
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
Recruiting
Address
H.U. Infanta Sofía
San Sebastián De Los Reyes, , 28702
Site Contact
Status
Recruiting
Address
Hosp. Clinico Univ. de Santiago
Santiago De Compostela, , 15706
Site Contact
Status
Recruiting
Address
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung, , 833
Site Contact
Status
Recruiting
Address
National Cheng Kung University Medical Center
Tainan, , 704
Site Contact
Status
Recruiting
Address
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan, , 333
Site Contact
Status
Recruiting
Address
Yildirim Beyazit University Medical Faculty
Ankara, , 6100
Site Contact
Status
Recruiting
Address
Akdeniz University Medical Faculty
Antalya, , 7059
Site Contact
Status
Recruiting
Address
Uludag University Medical Faculty
Bursa, , 16059
Site Contact
Status
Recruiting
Address
Osmangazi University Medical Faculty
Eskisehir, , 26480
Site Contact
Status
Recruiting
Address
Bakirkoy Training and Research Hospital
Istanbul, , 34147
Site Contact
Status
Recruiting
Address
Marmara University Medical Faculty
Istanbul, , 34899
Site Contact
Status
Recruiting
Address
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, , 35340
Site Contact
Status
Recruiting
Address
İzmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
Izmir, , 35360
Site Contact
Status
Recruiting
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
Withdrawn
Address
Ukrainian State Scientific And Research Institute Of Medical And Social Problems Of Disablement
Dnipro, , 61029
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
Recruiting
Address
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv, , 61029
Site Contact
Status
Withdrawn
Address
Regional Clinical Specialized Center Of Radiation Protection
Kharkiv, , 61166
Site Contact
Status
Recruiting
Address
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, ,
Site Contact
Status
Recruiting
Address
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, ,
Site Contact
Status
Recruiting
Address
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kherson, , 73000
Site Contact
Status
Recruiting
Address
City Clinical Hospital No. 2
Kryvyi Rih, , 50056
Site Contact
Status
Recruiting
Address
Medical Center 'Consylium Medical'
Kyiv, , 04050
Site Contact
Status
Recruiting
Address
Kyiv Railway Station Clinical Hospital #2
Kyiv, ,
Site Contact
Status
Withdrawn
Address
Republican clinical hospital the ministry of health of Ukraine, National Medical University
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
Lviv Communcal City Clinical Hospital #4
Lviv, ,
Site Contact
Status
Recruiting
Address
Multidisciplinary Medical Center of Odessa National Medical University (University Clinic №1)
Odessa, , 65026
Site Contact
Status
Recruiting
Address
State Institution Odesa Regional Clinical Hospital
Odessa, ,
Site Contact
Status
Recruiting
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
Recruiting
Address
Transcarpathian Regional Clinical Hospital
Uzhgorod, ,
Site Contact
Status
Recruiting
Address
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsya, , 21009
Site Contact
Status
Recruiting
Address
Vinnytsya State Medical University, Vinnytsya Regional Clinical Hospital
Vinnytsya, ,
Site Contact
Status
Withdrawn
Address
Communal Institution City Clinical Hospital #6 Of Zaporizhzhya City
Zaporizhzhya, , 69035
Site Contact
Status
Recruiting
Address
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, ,
Site Contact
Status
Recruiting
Address
Municipal institution Central Clinical Hospital #1 Zhytomir
Zhytomir, , 10002
Site Contact
