A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

Who is this study for? Patients with active psoriatic arthritis and inadequate response and/or intolerance to a prior anti-tumor necrosis factor
What treatments are being studied? Guselkumab
Status: Active_not_recruiting
Location: See all (162) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Arthritis Associates
Mountain Brook
Arkansas
Unity Health-White County Medical Center
Searcy
Arizona
Arizona Arthritis and Rheumatology Research PLLC
Avondale
Arizona Arthritis and Rheumatology Research PLLC
Flagstaff
Arizona Arthritis and Rheumatology Research PLLC
Mesa
Arizona Arthritis and Rheumatology Research PLLC
Phoenix
Arizona Arthritis and Rheumatology Associates
Sun City
Southern Arizona VA Healthcare System
Tucson
California
Newport Huntington Medical Group
Huntington Beach
Medvin Clinical Research
Thousand Oaks
Medvin Clinical Research
Tujunga
Connecticut
Clinical Research Center of Connecticut
Danbury
Florida
Bay Pines VA Healthcare System
Bay Pines
Clinical Research of West Florida
Clearwater
Omega Research Consultants
Debary
Advanced Clinical Research of Orlando
Ocoee
Integral Rheumatology And Immunology Specialists
Plantation
Clinical Research of West Florida
Tampa
Florida Medical Clinic, P.A.
Zephyrhills
Illinois
Great Lakes Clinical Trials
Chicago
Clinic of Robert Hozman
Skokie
Louisiana
The Arthritis and Diabetes Clinic
Monroe
Maryland
Johns Hopkins University
Baltimore
Klein And Associates M D P A
Hagerstown
Michigan
Great Lakes Center of Rheumatology
Lansing
Arthritis and Rheumatology Center of MI
Okemos
Clinical Research Institute of Michigan, LLC
Saint Clair Shores
Minnesota
St. Paul Rheumatology P A
Eagan
Missouri
Arthritis Consultants
St Louis
North Carolina
DJL Clinical Research, PLLC
Charlotte
New Jersey
Arthritis Rheumatic And Back Disease Associates
Voorhees Township
New Mexico
Albuquerque Center for Rheumatology
Albuquerque
Arthritis and Osteoperosis Associates of New Mexico
Las Cruces
New York
Buffalo Rheumatology and Medicine PLLC
Orchard Park
Ohio
STAT Research, Inc.
Vandalia
Oklahoma
Health Research of Oklahoma
Oklahoma City
Rheumatology Associates of Oklahoma
Oklahoma City
Tennessee
Dr. Ramesh Gupta
Memphis
Texas
Precision Comprehensive Clinical Research Solutions
Colleyville
Adriana Pop Moody MD Clinic PA
Corpus Christi
Metroplex Clinical Research Center
Dallas
Precision Comprehensive Clinical Research Solutions
Fort Worth
West Texas Clinical Research
Lubbock
Southwest Rheumatology Research LLC
Mesquite
Texas Rheumatology Care
Plano
Advanced Rheumatology of Houston
The Woodlands
DM Clinical Research
Tomball
Arthritis And Osteoporosis Clinic
Waco
Washington
Arthritis Northwest PLLC
Spokane
West Virginia
Rheumatology and Pulmonary Clinic
Beckley
Other Locations
Argentina
Centro Privado de Medicina Familiar
Buenos Aires
CIPREC
Buenos Aires
Cosultorios Reumatologógicos Pampa
Buenos Aires
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires
OMI
Buenos Aires
Instituto de Reumatología Mendoza
Mendoza
Centro de Investigaciones Medicas Tucuman
San Miguel De Tucumán
Australia
Southern Clinical Research
Hobart
Liverpool Hospital
Liverpool
Eastern Health - Box Hill Hospital
Melbourne
Skin Health Institute Inc.
Melbourne
Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven
Medical Center Unimed Plovdiv
Plovdiv
UMHAT Kaspela
Plovdiv
Diagnosis-consulting centre-1
Rousse
ASIMP Rheumatology Centre St Irina EOOD
Sofia
Medical Centre Synexus
Sofia
Military Medical Academy
Sofia
UMHAT St. Ivan Rilski
Sofia
University Multiprofile Hospital Sofiamed Sofia
Sofia
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest
Uno Medical Trials Ltd.
Budapest
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
Debrecen
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula
Pest Megyei Flor Ferenc Korhaz
Kistarcsa
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém
Israel
Bnai Zion Medical Center
Haifa
Carmel Medical Center
Haifa
Rambam Health Care Campus
Haifa
Meir Medical Center
Kfar Saba
Sheba Medical Center
Ramat Gan
Malaysia
Hospital Selayang
Batu Caves
Hospital Pulau Pinang
George Town
Hospital Raja Permaisuri Bainun
Ipoh
Hospital Tuanku Jaafar
Seremban
Poland
Nzoz Bif Med
Bytom
Centrum Kliniczno Badawcze
Elblag
Centrum Medyczne Promed
Krakow
Malopolskie Badania Kliniczne Sp z o o
Krakow
Malopolskie Centrum Kliniczne
Krakow
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz
Dermed Centrum Medyczne Sp z o o
Lodz
NZOZ Lecznica MAK MED S C
Nadarzyn
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól
Centrum Medyczne
Poznan
Twoja Przychodnia PCM
Poznan
Lubelskie Centrum Diagnostyczne
Świdnik
Centrum Medyczne Reuma Park
Warsaw
MICS Centrum Medyczne Warszawa
Warsaw
Rheuma Medicus Sp z o o
Warsaw
WroMedica I Bielicka A Strzalkowska s c
Wroclaw
Puerto Rico
FDI Clinical Research
San Juan
GCM Medical Group
San Juan
Mindful Medical Research
San Juan
Russian Federation
Altay Medical State University
Barnaul
Chelyabinck Regional Clinical Hospital
Chelyabinsk
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk
Kemerovo State Medical University
Kemerovo
LLL Medical Center Revma-Med
Kemerovo
LLC Family Outpatient Clinic # 4
Korolyov
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
Krasnoyarsk
Clinical-Diagnostic Center Euromedservice, JSC
Moscow
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow
GBOU VPO Orenburg State Medical University
Orenburg
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov
St. Petersburg GBUZ Clinical Reumatological Hospital 25
Saint Petersburg
X7 Clinical Research Company Limited
Saint Petersburg
Saratov Regional Clinical Hospital
Saratov
Smolensk regional hospital on Smolensk railway station
Smolensk
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
Tolyatti
Tula Regional Clinical Dermatovenerological Dispensary
Tula
Republican Clinical Hospital - G.G. Kuvatov
Ufa
Spain
Hosp. Univ. de Cruces
Barakaldo
Hosp. Quiron Madrid Pozuelo
Madrid
Hosp. Univ. de La Princesa
Madrid
Hosp Regional Univ de Malaga
Málaga
Clinica Gaias
Santiago De Compostela
Hosp. Quiron Sagrado Corazon
Seville
Hosp. Clinico Univ. de Valencia
Valencia
Turkey
Adana City Hospital
Adana
Ankara Bilkent City Hospital
Ankara
Gulhane Training and Research Hospital
Ankara
Hacettepe University Medical Faculty
Ankara
Akdeniz University Medical Faculty
Antalya
Uludag University Medical Faculty
Bursa
Pamukkale University Medical Faculty
Denizli
Osmangazi University Medical Faculty
Eskişehir
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Istanbul University Istanbul Medical Faculty
Istanbul
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul
Marmara University Medical Faculty
Istanbul
Kocaeli University Medical Faculty
Kocaeli
Necmettin Erbakan University Meram Medical Faculty
Konya
Ukraine
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv
Khmelnitckiy regional hospital
Khmelnytsky
City Clinical Hospital No. 2
Kryvyi Rih
Kyiv City Clinical Hospital #3
Kyiv
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv
Medical Center 'Consylium Medical'
Kyiv
Medical Center LLC 'Harmony of Beauty'
Kyiv
Medical Center of 'Institute of Rheumatology', LLC
Kyiv
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv
Volyn Regional Clinical Hospital
Lutsk
LLC Medical House
Odesa
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsia
Medical Center LLC 'Modern Clinic'
Zaporizhzhya
Time Frame
Start Date: 2021-09-28
Completion Date: 2026-07-16
Participants
Target number of participants: 453
Treatments
Experimental: Group 1: Guselkumab and Placebo
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Experimental: Group 2: Guselkumab
Participants will receive guselkumab SC.
Experimental: Group 3: Placebo Followed by Guselkumab
Participants will receive placebo SC and will cross over to receive guselkumab SC.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov