A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

Study Purpose

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 a prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy by assessing clinical response compared with guselkumab monotherapy.

Recruitment Criteria

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 - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and high-sensitivity C-reactive protein (hsCRP) >= 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory.
  • - 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 1 anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite previous treatment with only 1 prior anti-TNF-alpha agent and the following: a.
Lack of benefit to 1 prior anti-TNF-alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, 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 screening visit (washout period)

Exclusion Criteria:

  • - Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease.
  • - Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments.
  • - Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician.
- Has received more than 1 prior anti-TNF-alpha agent (or biosimilars) - Positive human immunodeficiency virus (HIV) antibody test

Trial Details

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.

NCT05071664
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 2
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 Poland, Russian Federation, Spain, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Psoriatic
Additional Details

PsA is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. Guselkumab is a fully human monoclonal antibody (mAb) directed against the p19 subunit of interleukin (IL)-23, 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. Golimumab is a fully human anti-TNF-alpha mAb that binds to TNF-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of TNF-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including PsA. This study will consist of a Screening Phase (up to 6 weeks), Double-blind Phase from Weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (Week 24), and Safety Follow-up Phase from Week 24 to Week 36. Key safety assessments will include adverse events (AEs), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (TB). The total duration of the study is up to 42 weeks.

Arms & Interventions

Arms

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.

Interventions

Drug: - Guselkumab

Guselkumab will be administered as a SC injection.

Drug: - Golimumab

Golimumab will be administered as a SC injection.

Drug: - Placebo

Placebo will be administered as a SC injection.

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.

Phoenix, Arizona

Status

Recruiting

Address

Arizona Arthritis and Rheumatology Research, PLLC

Phoenix, Arizona, 85032

Bay Pines VA Healthcare System, Bay Pines, Florida

Status

Not yet recruiting

Address

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744

NYU School of Medicine, New York, New York

Status

Not yet recruiting

Address

NYU School of Medicine

New York, New York, 10016

University of Rochester, Rochester, New York

Status

Not yet recruiting

Address

University of Rochester

Rochester, New York, 14642

STAT Research, Inc., Vandalia, Ohio

Status

Recruiting

Address

STAT Research, Inc.

Vandalia, Ohio, 45377

DM Clinical Research, Tomball, Texas

Status

Recruiting

Address

DM Clinical Research

Tomball, Texas, 77375

International Sites

Centrum Kliniczno Badawcze, Elblag, Poland

Status

Recruiting

Address

Centrum Kliniczno Badawcze

Elblag, , 82-300

Lodz, Poland

Status

Recruiting

Address

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, , 90-242

NZOZ Lecznica MAK-MED. S.C., Nadarzyn, Poland

Status

Recruiting

Address

NZOZ Lecznica MAK-MED. S.C.

Nadarzyn, , 05-830

Centrum Medyczne, Poznan, Poland

Status

Recruiting

Address

Centrum Medyczne

Poznan, , 61-113

Medycyna Kliniczna, Warsaw, Poland

Status

Recruiting

Address

Medycyna Kliniczna

Warsaw, , 00-874

Centrum Medyczne AMED Warszawa Targowek, Warszawa, Poland

Status

Recruiting

Address

Centrum Medyczne AMED Warszawa Targowek

Warszawa, , 03-291

Wrocław, Poland

Status

Recruiting

Address

WroMedica I.Bielicka, A.Strzałkowska s.c.

Wrocław, , 51-685

Chelyabinck Regional Clinical Hospital, Chelyabinsk, Russian Federation

Status

Withdrawn

Address

Chelyabinck Regional Clinical Hospital

Chelyabinsk, , 454076

Kemerovo State Medical University, Kemerovo, Russian Federation

Status

Terminated

Address

Kemerovo State Medical University

Kemerovo, , 650000

LLL Medical Center Revma-Med, Kemerovo, Russian Federation

Status

Terminated

Address

LLL Medical Center Revma-Med

Kemerovo, , 650070

LLC Family Outpatient Clinic # 4, Korolev, Russian Federation

Status

Terminated

Address

LLC Family Outpatient Clinic # 4

Korolev, , 141060

Krasnodar, Russian Federation

Status

Withdrawn

Address

Krasnodar Clinical Dermatovenerologic Dispensary

Krasnodar, , 350020

Moscow, Russian Federation

Status

Withdrawn

Address

Clinical-Diagnostic Center Euromedservice, JSC

Moscow, , 115419

Moscow, Russian Federation

Status

Terminated

Address

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, , 115522

Moscow, Russian Federation

Status

Suspended

Address

GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

Moscow, , 129110

Orenburg State Medical Academy, Orenburg, Russian Federation

Status

Terminated

Address

Orenburg State Medical Academy

Orenburg, , 460000

Rostov, Russian Federation

Status

Suspended

Address

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, , 344007

Ryazan, Russian Federation

Status

Completed

Address

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, , 390046

Smolensk, Russian Federation

Status

Terminated

Address

Smolensk regional hospital on Smolensk railway station

Smolensk, , 214025

X7 Clinical Research Company Limited, St. Petersburg, Russian Federation

Status

Terminated

Address

X7 Clinical Research Company Limited

St. Petersburg, , 194156

Tula, Russian Federation

Status

Withdrawn

Address

Tula Regional Clinical Dermatovenerological Dispensary

Tula, , 300053

Ufa, Russian Federation

Status

Suspended

Address

Republican Clinical Hospital - G.G. Kuvatov

Ufa, , 450005

Yaroslavl, Russian Federation

Status

Terminated

Address

Clinical Emergency Hospital n.a. N.V. Solovyev

Yaroslavl, , 150003

Clinical Hospital #3, Yaroslavl, Russian Federation

Status

Terminated

Address

Clinical Hospital #3

Yaroslavl, , 150007

Hosp. Univ. A Coruña, A Coruña, Spain

Status

Recruiting

Address

Hosp. Univ. A Coruña

A Coruña, , 15006

Hosp. Univ. Germans Trias I Pujol, Barcelona, Spain

Status

Recruiting

Address

Hosp. Univ. Germans Trias I Pujol

Barcelona, , 08916

Hosp. Univ. de Basurto, Bilbao, Spain

Status

Recruiting

Address

Hosp. Univ. de Basurto

Bilbao, , 48013

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Withdrawn

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Clinico Univ. de Santiago, Santiago de Compostela, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , 15706

Hosp. Virgen Macarena, Sevilla, Spain

Status

Recruiting

Address

Hosp. Virgen Macarena

Sevilla, , 41009

Hosp. Ntra. Sra. de Valme, Sevilla, Spain

Status

Recruiting

Address

Hosp. Ntra. Sra. de Valme

Sevilla, , 41014

Hosp. Univ. I Politecni La Fe, Valencia, Spain

Status

Withdrawn

Address

Hosp. Univ. I Politecni La Fe

Valencia, , 46026

Kharkiv, Ukraine

Status

Suspended

Address

State Institution Institute of therapy named after L.T.Malaya AMS Ukraine

Kharkiv, , 61039

Kharkiv, Ukraine

Status

Suspended

Address

Municipal Institution Regional hospital-center of emergency care and disasters medicine

Kharkiv, , 61204

Kyiv, Ukraine

Status

Suspended

Address

Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud

Kyiv, , 03037

Kyiv, Ukraine

Status

Suspended

Address

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

Kyiv, , 03049

Kyiv, Ukraine

Status

Suspended

Address

SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

Kyiv, , 03680

Kyiv, Ukraine

Status

Suspended

Address

Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'

Kyiv, , 04107

Poltava, Ukraine

Status

Suspended

Address

ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

Poltava, , 36011

Ternopil, Ukraine

Status

Suspended

Address

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, , 46002

Uzhgorod, Ukraine

Status

Suspended

Address

MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

Uzhgorod, , 88000

Health Clinic Limited Liability Company, Vinnytsia, Ukraine

Status

Suspended

Address

Health Clinic Limited Liability Company

Vinnytsia, , 21009

Medical Center LLC 'Modern Clinic', Zaporizhzhya, Ukraine

Status

Suspended

Address

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, , 69600

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