A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Who is this study for? Patients with Psoriatic Arthritis
What treatments are being studied? Guselkumab
Status: Completed
Location: See all (82) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (\>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening

• Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline

• Have at least 1 of the following 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

• Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)

Locations
United States
Arkansas
Unity Health-White County Medical Center
Searcy
Arizona
Arizona Arthritis and Rheumatology Research PLLC
Phoenix
Arizona Arthritis and Rheumatology Research PLLC
Phoenix
Florida
HARAC Research Corp
Avon Park
Bay Pines VA Healthcare System
Bay Pines
Omega Research Consultants
Debary
South Coast Research Center
Miami
Advanced Clinical Research of Orlando
Ocoee
Millennium Research
Ormond Beach
Georgia
Atlanta Research Center for Rheumatology
Marietta
Michigan
Great Lakes Center of Rheumatology
Lansing
Missouri
Clinvest
Springfield
New York
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn
NYU School of Medicine
New York
University of Rochester
Rochester
Jacobi Medical Center
The Bronx
Ohio
STAT Research, Inc.
Vandalia
Texas
Trinity Universal Research Associates, LLC
Plano
DM Clinical Research
Tomball
Washington
Swedish Medical Center
Seattle
Other Locations
Denmark
Frederiksberg Hospital
Frederiksberg
Rigshospitalet Glostrup
Glostrup Municipality
Køge Sygehus Region Sjaelland
Køge
Silkeborg Hospital
Silkeborg
Vejle Sygehus
Vejle
France
Centre Hospitalier Le Mans
Le Mans
Hopital Larrey CHU de Toulouse
Toulouse
CHU Trousseau - Service de Rhumatologie
Tours
Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula
Complex Rendelo Med Zrt
Székesfehérvár
Vital Medical Center
Veszprém
Italy
Azienda Ospedaliero-Universitaria di Cagliari
Cagliari
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milan
Ospedale San Raffaele
Milan
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia
A.O.U.Policlinico Tor Vergata
Roma
Policlinico Universitario Agostino Gemelli
Roma
Università Campus Biomedico di Roma
Rome
AO Ordine Mauriziano
Torino
Poland
Centrum Kliniczno Badawcze
Elblag
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz
NZOZ Lecznica MAK MED S C
Nadarzyn
Centrum Medyczne
Poznan
Centrum Medyczne AMED Targowek
Warsaw
Medycyna Kliniczna
Warsaw
WroMedica I Bielicka A Strzalkowska s c
Wroclaw
Russian Federation
Kemerovo State Medical University
Kemerovo
LLL Medical Center Revma-Med
Kemerovo
LLC Family Outpatient Clinic # 4
Korolyov
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow
Orenburg State Medical Academy
Orenburg
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan
X7 Clinical Research Company Limited
Saint Petersburg
Smolensk regional hospital on Smolensk railway station
Smolensk
Republican Clinical Hospital - G.G. Kuvatov
Ufa
Clinical Hospital #3
Yaroslavl
Spain
Hosp Univ A Coruna
A Coruña
Hosp. Univ. Germans Trias I Pujol
Barcelona
Hosp. Univ. de Basurto
Bilbao
Hosp Reina Sofia
Córdoba
Hosp. Univ. 12 de Octubre
Madrid
Corporacio Sanitari Parc Tauli
Sabadell
Hosp. Clinico Univ. de Santiago
Santiago De Compostela
Hosp. Infanta Luisa
Seville
Hosp. Ntra. Sra. de Valme
Seville
Hosp. Virgen Macarena
Seville
Sweden
Skanes universitetssjukhus
Malmo
Karolinska Universitetssjukhuset Solna
Solna
Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
Kyiv
Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
Kyiv
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhhorod
Health Clinic Limited Liability Company
Vinnytsia
Medical Center LLC 'Modern Clinic'
Zaporizhzhya
Time Frame
Start Date: 2021-10-25
Completion Date: 2024-08-06
Participants
Target number of participants: 91
Treatments
Experimental: Group 1: Guselkumab and Golimumab
Participants will receive subcutaneous (SC) guselkumab and golimumab.
Active_comparator: Group 2: Guselkumab and Placebo
Participants will receive SC guselkumab and placebo.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov