A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

Who is this study for? Patients with active psoriatic arthritis axial disease
What treatments are being studied? Guselkumab
Status: Recruiting
Location: See all (231) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.

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

• Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening

• Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

• Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac \[SI\] joints, shown by a Spondyloarthritis Research Consortium of Canada \[SPARCC\] score of \>= 3 in either the spine or the sacroiliac joints)

• Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale \[VAS\]) of at least 4

• Have active plaque psoriasis, with at least 1 psoriatic plaque of \>= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Locations
United States
Arkansas
Unity Health-White County Medical Center
RECRUITING
Searcy
Arizona
Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
Avondale
Arizona Arthritis & Rheumatology Research, PLLC
RECRUITING
Chandler
Arizona Arthritis and Rheumatology Research PLLC
RECRUITING
Mesa
Arizona Arthritis Research, PLC.
RECRUITING
Phoenix
Arizona Arthritis and Rheumatology Associates
RECRUITING
Sun City
Southern Arizona VA Healthcare System
RECRUITING
Tucson
California
Kaiser Permanent Medical Center
RECRUITING
Fontana
Newport Huntington Medical Group
RECRUITING
Huntington Beach
University Of California San Diego
RECRUITING
La Jolla
Rheumatology Center of San Diego
RECRUITING
San Diego
Connecticut
Clinical Research Center of Connecticut
COMPLETED
Danbury
Florida
Bay Pines VA Healthcare System
RECRUITING
Bay Pines
Integral Rheumatology And Immunology Specialists
RECRUITING
Plantation
Florida Medical Clinic, P.A.
COMPLETED
Zephyrhills
Illinois
Great Lakes Clinical Trials
COMPLETED
Chicago
OrthoIllinois
RECRUITING
Rockford
Willow Rheumatology and Wellness
RECRUITING
Willowbrook
Maryland
Johns Hopkins Bayview Medical
RECRUITING
Baltimore
Klein And Associates M D P A
COMPLETED
Hagerstown
Michigan
Clinical Research Institute of Michigan, LLC
RECRUITING
Saint Clair Shores
Minnesota
St. Paul Rheumatology P A
RECRUITING
Eagan
Missouri
Kansas City Physician Partners
RECRUITING
Kansas City
Clinvest
COMPLETED
Springfield
Ohio
STAT Research, Inc.
COMPLETED
Vandalia
Oregon
OHSU Rheumatology Clinic, Marquam Hill
RECRUITING
Portland
Texas
Amarillo Center for Clinical Research
COMPLETED
Amarillo
Austin Regional Clinic
COMPLETED
Austin
Precision Comprehensive Clinical Research Solutions
RECRUITING
Colleyville
Adriana Pop Moody MD Clinic PA
COMPLETED
Corpus Christi
AARA Clinical Research Lone Star Arthritis and Rheumatology
RECRUITING
Fort Worth
UT Physicians Center for Autoimmunity
RECRUITING
Houston
AARA Clinical Research Lone Star Arthritis and Rheumatology
RECRUITING
Irving
West Texas Clinical Research
RECRUITING
Lubbock
Southwest Rheumatology Research LLC
COMPLETED
Mesquite
Epic Medical Research
COMPLETED
Red Oak
DM Clinical Research
COMPLETED
Tomball
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Argentina
Centro Privado de Medicina Familiar
RECRUITING
Buenos Aires
Cosultorios Reumatologógicos Pampa
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Hospital Italiano La Plata
RECRUITING
La Plata
MR Medicina Reumatologica
RECRUITING
San Fernando
Centro Medico Privado de Reumatologia
RECRUITING
San Miguel De Tucumán
Australia
Emeritus Research
COMPLETED
Camberwell
Southern Clinical Research
COMPLETED
Hobart
Liverpool Hospital
COMPLETED
Liverpool
Rheumatology Research Unit
TERMINATED
Maroochydore
Eastern Health - Box Hill Hospital
COMPLETED
Melbourne
Skin Health Institute Inc.
TERMINATED
Melbourne
Bulgaria
Exacta Medica
RECRUITING
Pleven
UMHAT 'Dr. Georgi Stranski', EAD
RECRUITING
Pleven
Medical Center Artmed
RECRUITING
Plovdiv
Medical Center Unimed Plovdiv
COMPLETED
Plovdiv
UMHAT Kaspela
RECRUITING
Plovdiv
ASIMP Rheumatology Centre St Irina EOOD
RECRUITING
Sofia
DCC Convex EOOD
RECRUITING
Sofia
Medical Centre Synexus
COMPLETED
Sofia
MHAT 'Lyulin' EAD
RECRUITING
Sofia
Military Medical Academy
RECRUITING
Sofia
UMHAT St. Ivan Rilski
RECRUITING
Sofia
University Multiprofile Hospital Sofiamed Sofia
COMPLETED
Sofia
DDC Sv. Ivan Rilski OOD
COMPLETED
Targovishte
Canada
G R M O Groupe de recherche en maladies osseuses Inc
RECRUITING
Québec
Eastern Regional Health Authority St Clares Mercy Hospital
RECRUITING
St. John's
Toronto Western Hospital
RECRUITING
Toronto
Skin Care Centre
RECRUITING
Vancouver
Denmark
Frederiksberg Hospital
RECRUITING
Frederiksberg
Rigshospitalet Glostrup
COMPLETED
Glostrup Municipality
Køge Sygehus Region Sjaelland
RECRUITING
Køge
Vejle Sygehus
RECRUITING
Vejle
Georgia
Ltd Health Center
RECRUITING
Batumi
LTD Clinic LJ
RECRUITING
Kutaisi
Clinic on Mtskheta Street
RECRUITING
T'bilisi
LTD 'Aversi Clinic'
RECRUITING
T'bilisi
Ltd American Hospital Network
RECRUITING
T'bilisi
Tbilisi Heart and Vascular Clinic Ltd
RECRUITING
T'bilisi
Aleksandre Aladashvili Clinic LLC
RECRUITING
Tbilisi
Consilium Medulla-multiprofile clinic Ltd
RECRUITING
Tbilisi
JSC K Eristavi National Center of experimental and Clinical surgery
RECRUITING
Tbilisi
LTD Helsicore
RECRUITING
Tbilisi
LTD MediClub Georgia
RECRUITING
Tbilisi
Ltd New Hospitals
RECRUITING
Tbilisi
LTD The First Medical Center
RECRUITING
Tbilisi
TSMU The First University Clinic
RECRUITING
Tbilisi
JSC Evex Hospitals
RECRUITING
Tnilisi
Germany
ISA - Interdisciplinary Study Association GmbH
RECRUITING
Berlin
Hamburger Rheuma Forschungszentrum II
COMPLETED
Hamburg
Rheumazentrum Ruhrgebiet
RECRUITING
Herne
Rheumazentrum Ratingen
COMPLETED
Ratingen
Hong Kong Special Administrative Region
Prince Of Wales Hospital
RECRUITING
Hong Kong
Hungary
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
RECRUITING
Budapest
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Budapest
Qualiclinic Kft
RECRUITING
Budapest
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
RECRUITING
Gyula
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
RECRUITING
Hódmezővásárhely
Kistarcsai Flor Ferenc Korhaz
RECRUITING
Kistarcsa
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
RECRUITING
Székesfehérvár
Vital Medical Center Orvosi es Fogaszati Kozpont
RECRUITING
Veszprém
Israel
Bnai Zion Medical Center
RECRUITING
Haifa
Carmel Medical Center
RECRUITING
Haifa
Wolfson Medical Center
COMPLETED
Holon
Meir Medical Center
COMPLETED
Kfar Saba
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
A.O. Universitaria Ospedali Riuniti di Ancona
RECRUITING
Ancona
Azienda Ospedaliero-Universitaria di Cagliari
RECRUITING
Monserrato
Arcispedale Santa Maria Nuova - IRCCS
RECRUITING
Reggio Emilia
Policlinico Tor Vergata
RECRUITING
Roma
Humanitas Hospital
RECRUITING
Rozzano (mi)
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Malaysia
Hospital Selayang
RECRUITING
Batu Caves
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Sultan Ismail
RECRUITING
Johor Bahru
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tuanku Jaafar
RECRUITING
Seremban
Philippines
Cebu Doctors' University Hospital
RECRUITING
Cebu City
Davao Doctors Hospital
RECRUITING
Davao City
Lipa Medix Medical Hospital
RECRUITING
Lipa
ManilaMed Medical Center Manila
RECRUITING
Manila
Philippine General Hospital
RECRUITING
Manila
St. Luke's Medical Center
RECRUITING
Quezon City
Ilocos Training and Regional Medical Center
RECRUITING
San Fernando City
Poland
ClinicMed Daniluk Nowak Spolka Komandytowa
RECRUITING
Bialystok
Szpital Uniwersytecki nr 2 im dr Jana Biziela
RECRUITING
Bydgoszcz
Nzoz Bif Med
RECRUITING
Bytom
Ambulatorium sp. z o.o.
RECRUITING
Elblag
Centrum Kliniczno Badawcze
COMPLETED
Elblag
Centrum Medyczne Promed
COMPLETED
Krakow
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
Centrum Medyczne AMED oddzial w Lodzi
RECRUITING
Lodz
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
RECRUITING
Lodz
Dermed Centrum Medyczne Sp z o o
RECRUITING
Lodz
Pro Life Medica Sp. z o.o.
RECRUITING
Lublin
Reumed Zespol Poradni Specjalistycznych Filia nr 1
RECRUITING
Lublin
Velocity Lublin
RECRUITING
Lublin
NZOZ Lecznica MAK MED S C
RECRUITING
Nadarzyn
Twoja Przychodnia - Centrum Medyczne Nowa Sol
RECRUITING
Nowa Sól
Reumedika s c Wieslawa Porawska Lukasz Porawski
RECRUITING
Poznan
Twoja Przychodnia PCM
RECRUITING
Poznan
Lubelskie Centrum Diagnostyczne
RECRUITING
Świdnik
MICS Centrum Medyczne Torun
RECRUITING
Torun
Centrum Medyczne AMED Targowek
RECRUITING
Warsaw
Centrum Medyczne Reuma Park
RECRUITING
Warsaw
ETG Warszawa
COMPLETED
Warsaw
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
RECRUITING
Warsaw
Rheuma Medicus Sp z o o
RECRUITING
Warsaw
WroMedica I Bielicka A Strzalkowska s c
RECRUITING
Wroclaw
Portugal
Uls Braga - Hosp. Braga
RECRUITING
Braga
Ulsg - Hosp. Sousa Martins
RECRUITING
Guarda
Hosp. Cuf Tejo
COMPLETED
Lisbon
Ipr Inst Port de Reumatologia
RECRUITING
Lisbon
Uls Lisboa Ocidental - Hosp. Egas Moniz
RECRUITING
Lisbon
Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Lisbon
Ulsam - Hosp. Conde de Bertiandos
RECRUITING
Ponte De Lima
Uls Sao Joao - Hosp. Sao Joao
COMPLETED
Porto
Russian Federation
Altay Medical State University
COMPLETED
Barnaul
Chelyabinck Regional Clinical Hospital
TERMINATED
Chelyabinsk
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
COMPLETED
Chelyabinsk
Regional Clinical Diagnostic Center of Udmurtia Region
COMPLETED
Izhevsk
LLL Medical Center Revma-Med
COMPLETED
Kemerovo
LLC Family Outpatient Clinic # 4
COMPLETED
Korolyov
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
TERMINATED
Krasnoyarsk
Clinical-Diagnostic Center Euromedservice, JSC
COMPLETED
Moscow
FGBU Research Institute of Rheumatology named V.A.Nasonova
COMPLETED
Moscow
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
COMPLETED
Moscow
Llc Ultramed
COMPLETED
Omsk
GBOU VPO Orenburg State Medical University
TERMINATED
Orenburg
GBUZ Perm Regional Clinical Hospital
TERMINATED
Perm
Republican Hospital n.a.V.A.Baranov
COMPLETED
Petrozavodsk
Rostov Regional Clinical Dermatovenerological Dispensary
COMPLETED
Rostov
St. Petersburg GBUZ Clinical Reumatological Hospital 25
COMPLETED
Saint Petersburg
X7 Clinical Research Company Limited
TERMINATED
Saint Petersburg
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
COMPLETED
Tolyatti
Republican Clinical Hospital - G.G. Kuvatov
COMPLETED
Ufa
Clinical Hospital #3
COMPLETED
Yaroslavl
Sverdlovsk Regional Clinical Hospital N. 1
TERMINATED
Yekaterinburg
Slovakia
Reumatologicka ambulancia
RECRUITING
Martin
Reumatologicka ambulancia
RECRUITING
Nové Mesto Nad Váhom
Reumatologická ambulancia Thermium s.r.o.
RECRUITING
Piešťany
REUMAMED POPRAD, s.r.o.
RECRUITING
Poprad
Reumex s.r.o
RECRUITING
Rimavská Sobota
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
Hosp. Univ. de Cruces
RECRUITING
Barakaldo
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp. Univ. de Basurto
RECRUITING
Bilbao
Hosp Reina Sofia
RECRUITING
Córdoba
Hosp. Clinico San Carlos
COMPLETED
Madrid
Hosp Regional Univ de Malaga
RECRUITING
Málaga
Corporacio Sanitari Parc Tauli
RECRUITING
Sabadell
Clinica Gaias
RECRUITING
Santiago De Compostela
Hosp. Quiron Sagrado Corazon
RECRUITING
Seville
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Sweden
Karolinska Universitetssjukhuset
RECRUITING
Solna
Akademiska Sjukhuset
RECRUITING
Uppsala
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan City
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
National Taiwan University Hospital
RECRUITING
Taoyuan District
Thailand
Phramongkutklao Hospital and Medical College
RECRUITING
Bangkok
Ramathibodi Hospital Mahidol University
RECRUITING
Bangkok
Chiang Mai University
RECRUITING
Chiang Mai
Turkey
Adana City Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
COMPLETED
Ankara
Gulhane Training and Research Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty
COMPLETED
Ankara
Akdeniz University Medical Faculty
COMPLETED
Antalya
Uludag University Medical Faculty
RECRUITING
Bursa
Istanbul University Cerrahpasa Medical Faculty
COMPLETED
Istanbul
Marmara University Medical Faculty
RECRUITING
Istanbul
Necmettin Erbakan University Meram Medical Faculty
RECRUITING
Konya
Ukraine
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
TERMINATED
Cherkasy
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
COMPLETED
Kharkiv
Khmelnitckiy regional hospital
TERMINATED
Khmelnytsky
City Clinical Hospital No. 2
TERMINATED
Kryvyi Rih
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
COMPLETED
Kyiv
Medical Center of 'Institute of Rheumatology', LLC
TERMINATED
Kyiv
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
COMPLETED
Kyiv
Volyn Regional Clinical Hospital
COMPLETED
Lutsk
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
TERMINATED
Odesa
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
TERMINATED
Poltava
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
COMPLETED
Ternopil
Health Clinic Limited Liability Company
TERMINATED
Vinnytsia
Medical Center LLC 'Modern Clinic'
TERMINATED
Zaporizhzhya
United Kingdom
Royal Free London NHS Foundation Trust
RECRUITING
Barnet
St. Lukes Hospital
RECRUITING
Bradford
University Hospital Coventry & Warwickshire NHS Trust
COMPLETED
Coventry
Chapel Allerton Hospital
RECRUITING
Leeds
Central Manchester University Hospitals NHS Foundation Trust
RECRUITING
Manchester
North Tyneside General Hospital
RECRUITING
Newcastle
Haywood Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2021-08-30
Estimated Completion Date: 2027-04-13
Participants
Target number of participants: 405
Treatments
Experimental: Group 1: Guselkumab and Placebo
Participants will receive guselkumab and matching 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 matching placebo and will cross over to receive guselkumab SC.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov