Psoriasis Clinical Trial

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Summary

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

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Full Description

PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of active 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 milligrams per deciliter (mg/dL) at screening from the central laboratory
Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent

Exclusion Criteria:

Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational 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
Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT04936308

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 168 Locations for this study

See Locations Near You

Rheumatology Associates
Birmingham Alabama, 35205, United States
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff Arizona, 86001, United States
Arizona Arthritis and Rheumatology Research PLLC
Mesa Arizona, 85210, United States
Arizona Arthritis and Rheumatology Research PLLC
Phoenix Arizona, 85032, United States
Arizona Arthritis and Rheumatology Research PLLC
Phoenix Arizona, 85037, United States
Arizona Arthritis and Rheumatology Associates
Sun City Arizona, 85351, United States
Southern Arizona VA Healthcare System
Tucson Arizona, 85723, United States
Unity Health-White County Medical Center
Searcy Arkansas, 72143, United States
Newport Huntington Medical Group
Huntington Beach California, 92648, United States
Medvin Clinical Research
Thousand Oaks California, 91360, United States
Medvin Clinical Research
Tujunga California, 91042, United States
Clinical Research Center of Connecticut
Danbury Connecticut, 06810, United States
Bay Pines VA Healthcare System
Bay Pines Florida, 33744, United States
Clinical Research of West Florida
Clearwater Florida, 33765, United States
Omega Research Consultants
DeBary Florida, 32713, United States
Advanced Clinical Research of Orlando
Ocoee Florida, 34761, United States
Integral Rheumatology And Immunology Specialists
Plantation Florida, 33324, United States
Clinical Research of West Florida
Tampa Florida, 33606, United States
Florida Medical Clinic, P.A.
Zephyrhills Florida, 33542, United States
Great Lakes Clinical Trials
Chicago Illinois, 60640, United States
Clinic of Robert Hozman
Skokie Illinois, 60076, United States
The Arthritis and Diabetes Clinic
Monroe Louisiana, 71203, United States
Johns Hopkins University
Baltimore Maryland, 21224, United States
Klein And Associates M D P A
Hagerstown Maryland, 21740, United States
Great Lakes Center of Rheumatology
Lansing Michigan, 48911, United States
Arthritis and Rheumatology Center of MI
Okemos Michigan, 48864, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores Michigan, 48081, United States
St. Paul Rhuematology P A
Eagan Minnesota, 55121, United States
Arthritis Consultants
Saint Louis Missouri, 63141, United States
Arthritis Rheumatic And Back Disease Associates
Voorhees New Jersey, 08043, United States
Albuquerque Center for Rheumatology
Albuquerque New Mexico, 87102, United States
Arthritis and Osteoperosis Associates of New Mexico
Las Cruces New Mexico, 88011, United States
Buffalo Rheumatology and Medicine PLLC
Orchard Park New York, 14127, United States
DJL Clinical Research, PLLC
Charlotte North Carolina, 28211, United States
STAT Research, Inc.
Vandalia Ohio, 45377, United States
Health Research of Oklahoma
Oklahoma City Oklahoma, 73103, United States
Rheumatology Associates of Oklahoma
Oklahoma City Oklahoma, 73116, United States
Dr. Ramesh Gupta
Memphis Tennessee, 38119, United States
Precision Comprehensive Clinical Research Solutions
Colleyville Texas, 76034, United States
Adriana Pop Moody MD Clinic PA
Corpus Christi Texas, 78404, United States
Metroplex Clinical Research Center
Dallas Texas, 75231, United States
Precision Comprehensive Clinical Research Solutions
Fort Worth Texas, 76107, United States
West Texas Clinical Research
Lubbock Texas, 79424, United States
Southwest Rheumatology Research LLC
Mesquite Texas, 75150, United States
Texas Rheumatology Care
Plano Texas, 75024, United States
Advanced Rheumatology of Houston
The Woodlands Texas, 77382, United States
DM Clinical Research
Tomball Texas, 77375, United States
Arthritis & Osteoporosis Clinic
Waco Texas, 76710, United States
Arthritis Northwest PLLC
Spokane Washington, 99204, United States
Rheumatology and Pulmonary Clinic
Beckley West Virginia, 25801, United States
Cosultorios Reumatologógicos Pampa
Buenos Aires , 1428, Argentina
Centro Privado de Medicina Familiar
Buenos Aires , C1417, Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires , C1426, Argentina
CIPREC
Ciudad Autonoma de Buenos Aires , C1061, Argentina
OMI
Ciudad Autónoma de Buenos Aires , C1015, Argentina
Instituto de Reumatología Mendoza
Ciudad de Mendoza , M5631, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel De Tucuman , T4000, Argentina
Southern Clinical Research
Hobart , 7000, Australia
Liverpool Hospital
Liverpool , 2170, Australia
Skin Health Institute Inc.
Melbourne , 3053, Australia
Eastern Health - Box Hill Hospital
Melbourne , 3128, Australia
UMHAT 'Dr. Georgi Stranski', EAD
Pleven , 5804, Bulgaria
Medical Center Unimed Plovdiv
Plovdiv , 4001, Bulgaria
UMHAT Kaspela
Plovdiv , 4001, Bulgaria
Diagnosis-consulting centre-1
Ruse , 7002, Bulgaria
UMHAT St. Ivan Rilski
Sfia , 1612, Bulgaria
Military Medical Academy
Sofia , 1606, Bulgaria
ASIMP Rheumatology Centre St Irina EOOD
Sofia , 1750, Bulgaria
University Multiprofile Hospital Sofiamed Sofia
Sofia , 1770, Bulgaria
Medical Centre Synexus
Sofia , 1794, Bulgaria
RHEUMA s r o
Breclav , 691 0, Czechia
L K N Arthrocentrum
Hlucin , 748 0, Czechia
MUDr Rosypalova s r o
Ostrava , 70800, Czechia
Arthrohelp S.R.O.
Pardubice , 53002, Czechia
Revmatologicky ustav
Praha 2 , 128 5, Czechia
Medical Plus S R O
Uherske Hradiste , 68601, Czechia
PV Medical S R O
Zlin , 76001, Czechia
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
Budapest , 1023, Hungary
Uno Medical Trials Ltd.
Budapest , 1152, Hungary
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
Debrecen , 4031, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula , 5700, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged , 6725, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Szekesfehervar , H-800, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprem , 8200, Hungary
Bnai Zion Medical Center
Haifa , 31048, Israel
Rambam Health Care Campus
Haifa , 31096, Israel
Carmel Medical Center
Hifa , 34362, Israel
Meir Medical Center
Kfar-Sava , 44281, Israel
Sheba Medical Center
Ramat Gan , 52656, Israel
Hospital Selayang
Batu Caves , 68100, Malaysia
Hospital Pulau Pinang
George Town , 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh , 30450, Malaysia
Hospital Tuanku Jaafar
Seremban , 70300, Malaysia
Nzoz Bif Med
Bytom , 41-90, Poland
Centrum Kliniczno Badawcze
Elblag , 82-30, Poland
Malopolskie Centrum Kliniczne
Krakow , 30 14, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow , 30-00, Poland
Centrum Medyczne Promed
Krakow , 31-51, Poland
Dermed Centrum Medyczne Sp z o o
Lodz , 90 26, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz , 90-33, Poland
NZOZ Lecznica MAK MED S C
Nadarzyn , 05 83, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sol , 67-10, Poland
Centrum Medyczne
Poznan , 61-11, Poland
Twoja Przychodnia
Poznan , 61-29, Poland
Lubelskie Centrum Diagnostyczne
Swidnik , 21-04, Poland
MICS Centrum Medyczne Warszawa
Warsaw , 00-87, Poland
Rheuma-Medicus, Zaklad Opieki Zdrowotnej
Warszawa , 02-11, Poland
Centrum Medyczne Reuma Park
Warszawa , 02-66, Poland
WroMedica I.Bielicka, A.Strzałkowska s.c.
Wrocław , 51-68, Poland
GCM Medical Group
San Juan , 00917, Puerto Rico
Mindful Medical Research
San Juan , 00918, Puerto Rico
FDI Clinical Research
San Juan , 00927, Puerto Rico
Altay Medical State University
Barnaul , 65603, Russian Federation
Chelyabinck Regional Clinical Hospital
Chelyabinsk , 45407, Russian Federation
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk , 45409, Russian Federation
Kemerovo State Medical University
Kemerovo , 65000, Russian Federation
LLL Medical Center Revma-Med
Kemerovo , 65007, Russian Federation
LLC Family Outpatient Clinic # 4
Korolev , 14106, Russian Federation
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar , 35002, Russian Federation
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
Krasnoyarsk , 66012, Russian Federation
Clinical-Diagnostic Center Euromedservice, JSC
Moscow , 11541, Russian Federation
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow , 11552, Russian Federation
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow , 12911, Russian Federation
GBOU VPO Orenburg State Medical University
Orenburg , 46000, Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov , 34400, Russian Federation
Saratov Regional Clinical Hospital
Saratov , 41005, Russian Federation
Smolensk regional hospital on Smolensk railway station
Smolensk , 21402, Russian Federation
St. Petersburg GBUZ Clinical Reumatological Hospital 25
St. Petersburg , 19006, Russian Federation
X7 Clinical Research Company Limited
St. Petersburg , 19415, Russian Federation
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
Tolyatti , 44584, Russian Federation
Tula Regional Clinical Dermatovenerological Dispensary
Tula , 30005, Russian Federation
Republican Clinical Hospital - G.G. Kuvatov
Ufa , 45000, Russian Federation
Hosp. Univ. de Cruces
Barakaldo , 48903, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Quiron Madrid Pozuelo
Madrid , 28223, Spain
Hosp. Regional Univ. de Malaga
Málaga , 29011, Spain
Clinica Gaias
Santiago de Compostela , 15702, Spain
Hosp. Quiron Sagrado Corazon
Sevilla , 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Adana City Hospital
Adana , 01370, Turkey
Gulhane Training and Research Hospital
Ankara , 06010, Turkey
Ankara Bilkent City Hospital
Ankara , 06800, Turkey
Hacettepe University Medical Faculty
Ankara , 6100, Turkey
Akdeniz University Medical Faculty
Antalya , 7059, Turkey
Uludag University Medical Faculty
Bursa , 16059, Turkey
Pamukkale University Medical Faculty
Denizli , 20070, Turkey
Osmangazi University Medical Faculty
Eskisehir , 26040, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul , 34865, Turkey
Marmara University Medical Faculty
Istanbul , 34899, Turkey
Kocaeli University Medical Faculty
Kocaeli , 41380, Turkey
Necmettin Erbakan University Meram Medical Faculty
Konya , 42080, Turkey
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy , 18009, Ukraine
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv , 61204, Ukraine
Khmelnitckiy regional hospital
Khmelnytsky , 29000, Ukraine
City Clinical Hospital No. 2
Kryvyi Rih , 50056, Ukraine
Medical Center LLC 'Harmony of Beauty'
Kyiv , 01135, Ukraine
Medical Center of 'Institute of Rheumatology', LLC
Kyiv , 02081, Ukraine
Kyiv City Clinical Hospital #3
Kyiv , 02125, Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv , 03049, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv , 03151, Ukraine
Medical Center 'Consylium Medical'
Kyiv , 04050, Ukraine
Volyn Regional Clinical Hospital
Lutsk , 43005, Ukraine
LLC Medical House
Odessa , 65026, Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava , 36011, Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsya , 21018, Ukraine
Medical Center LLC 'Modern Clinic'
Zaporizhzhya , 69600, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT04936308

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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