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

NCT ID: NCT04936308

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2026-07-16

Brief 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.

Detailed 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.

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Guselkumab and Placebo

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive guselkumab as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo as SC injection.

Group 2: Guselkumab

Participants will receive guselkumab SC.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive guselkumab as SC injection.

Group 3: Placebo Followed by Guselkumab

Participants will receive placebo SC and will cross over to receive guselkumab SC.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

Participants will receive guselkumab as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo as SC injection.

Interventions

Guselkumab

Participants will receive guselkumab as SC injection.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo as SC injection.

Intervention Type: DRUG

Other Intervention Names

Tremfya; CNTO1959

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arthritis Associates

Mountain Brook, Alabama, United States

Arizona Arthritis and Rheumatology Research PLLC

Avondale, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Flagstaff, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Mesa, Arizona, United States

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, United States

Arizona Arthritis and Rheumatology Associates

Sun City, Arizona, United States

Southern Arizona VA Healthcare System

Tucson, Arizona, United States

Unity Health-White County Medical Center

Searcy, Arkansas, United States

Newport Huntington Medical Group

Huntington Beach, California, United States

Medvin Clinical Research

Thousand Oaks, California, United States

Medvin Clinical Research

Tujunga, California, United States

Clinical Research Center of Connecticut

Danbury, Connecticut, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Clinical Research of West Florida

Clearwater, Florida, United States

Omega Research Consultants

DeBary, Florida, United States

Advanced Clinical Research of Orlando

Ocoee, Florida, United States

Integral Rheumatology And Immunology Specialists

Plantation, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Clinic of Robert Hozman

Skokie, Illinois, United States

The Arthritis and Diabetes Clinic

Monroe, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Klein And Associates M D P A

Hagerstown, Maryland, United States

Great Lakes Center of Rheumatology

Lansing, Michigan, United States

Arthritis and Rheumatology Center of MI

Okemos, Michigan, United States

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Michigan, United States

St. Paul Rheumatology P A

Eagan, Minnesota, United States

Arthritis Consultants

St Louis, Missouri, United States

Arthritis Rheumatic And Back Disease Associates

Voorhees Township, New Jersey, United States

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States

Arthritis and Osteoperosis Associates of New Mexico

Las Cruces, New Mexico, United States

Buffalo Rheumatology and Medicine PLLC

Orchard Park, New York, United States

DJL Clinical Research, PLLC

Charlotte, North Carolina, United States

STAT Research, Inc.

Vandalia, Ohio, United States

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Rheumatology Associates of Oklahoma

Oklahoma City, Oklahoma, United States

Dr. Ramesh Gupta

Memphis, Tennessee, United States

Precision Comprehensive Clinical Research Solutions

Colleyville, Texas, United States

Adriana Pop Moody MD Clinic PA

Corpus Christi, Texas, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Precision Comprehensive Clinical Research Solutions

Fort Worth, Texas, United States

West Texas Clinical Research

Lubbock, Texas, United States

Southwest Rheumatology Research LLC

Mesquite, Texas, United States

Texas Rheumatology Care

Plano, Texas, United States

Advanced Rheumatology of Houston

The Woodlands, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Arthritis And Osteoporosis Clinic

Waco, Texas, United States

Arthritis Northwest PLLC

Spokane, Washington, United States

Rheumatology and Pulmonary Clinic

Beckley, West Virginia, United States

Cosultorios Reumatologógicos Pampa

Buenos Aires, , Argentina

OMI

Buenos Aires, , Argentina

CIPREC

Buenos Aires, , Argentina

Centro Privado de Medicina Familiar

Buenos Aires, , Argentina

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Buenos Aires, , Argentina

Instituto de Reumatología Mendoza

Mendoza, , Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, , Argentina

Southern Clinical Research

Hobart, , Australia

Liverpool Hospital

Liverpool, , Australia

Skin Health Institute Inc.

Melbourne, , Australia

Eastern Health - Box Hill Hospital

Melbourne, , Australia

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

Medical Center Unimed Plovdiv

Plovdiv, , Bulgaria

UMHAT Kaspela

Plovdiv, , Bulgaria

Diagnosis-consulting centre-1

Rousse, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

UMHAT St. Ivan Rilski

Sofia, , Bulgaria

ASIMP Rheumatology Centre St Irina EOOD

Sofia, , Bulgaria

University Multiprofile Hospital Sofiamed Sofia

Sofia, , Bulgaria

Medical Centre Synexus

Sofia, , Bulgaria

RHEUMA s r o

Břeclav, , Czechia

L K N Arthrocentrum

Hlučín, , Czechia

MUDr Rosypalova s r o

Ostrava, , Czechia

Arthrohelp S.R.O.

Pardubice, , Czechia

Revmatologicky ustav

Prague, , Czechia

Medical Plus S R O

Uherské Hradiště, , Czechia

PV Medical S R O

Zlín, , Czechia

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Uno Medical Trials Ltd.

Budapest, , Hungary

Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ

Szeged, , Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, , Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, , Hungary

Bnai Zion Medical Center

Haifa, , Israel

Rambam Health Care Campus

Haifa, , Israel

Carmel Medical Center

Haifa, , Israel

Meir Medical Center

Kfar Saba, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Hospital Selayang

Batu Caves, , Malaysia

Hospital Pulau Pinang

George Town, , Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, , Malaysia

Hospital Tuanku Jaafar

Seremban, , Malaysia

Nzoz Bif Med

Bytom, , Poland

Centrum Kliniczno Badawcze

Elblag, , Poland

Malopolskie Badania Kliniczne Sp z o o

Krakow, , Poland

Malopolskie Centrum Kliniczne

Krakow, , Poland

Centrum Medyczne Promed

Krakow, , Poland

Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, , Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, , Poland

Twoja Przychodnia - Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

Twoja Przychodnia PCM

Poznan, , Poland

Centrum Medyczne

Poznan, , Poland

Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

Rheuma Medicus Sp z o o

Warsaw, , Poland

Centrum Medyczne Reuma Park

Warsaw, , Poland

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, , Poland

GCM Medical Group

San Juan, , Puerto Rico

Mindful Medical Research

San Juan, , Puerto Rico

FDI Clinical Research

San Juan, , Puerto Rico

Altay Medical State University

Barnaul, , Russia

Chelyabinck Regional Clinical Hospital

Chelyabinsk, , Russia

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

Chelyabinsk, , Russia

Kemerovo State Medical University

Kemerovo, , Russia

LLL Medical Center Revma-Med

Kemerovo, , Russia

LLC Family Outpatient Clinic # 4

Korolyov, , Russia

Krasnodar Clinical Dermatovenerologic Dispensary

Krasnodar, , Russia

Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon

Krasnoyarsk, , Russia

Clinical-Diagnostic Center Euromedservice, JSC

Moscow, , Russia

FGBU Research Institute of Rheumatology named V.A.Nasonova

Moscow, , Russia

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

Moscow, , Russia

GBOU VPO Orenburg State Medical University

Orenburg, , Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, , Russia

St. Petersburg GBUZ Clinical Reumatological Hospital 25

Saint Petersburg, , Russia

X7 Clinical Research Company Limited

Saint Petersburg, , Russia

Saratov Regional Clinical Hospital

Saratov, , Russia

Smolensk regional hospital on Smolensk railway station

Smolensk, , Russia

GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'

Tolyatti, , Russia

Tula Regional Clinical Dermatovenerological Dispensary

Tula, , Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, , Russia

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp. Univ. de La Princesa

Madrid, , Spain

Hosp. Quiron Madrid Pozuelo

Madrid, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Clinica Gaias

Santiago de Compostela, , Spain

Hosp. Quiron Sagrado Corazon

Seville, , Spain

Hosp. Clinico Univ. de Valencia

Valencia, , Spain

Adana City Hospital

Adana, , Turkey (Türkiye)

Gulhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, , Turkey (Türkiye)

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Pamukkale University Medical Faculty

Denizli, , Turkey (Türkiye)

Osmangazi University Medical Faculty

Eskişehir, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Kartal Dr Lutfi Kirdar sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, , Turkey (Türkiye)

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, , Ukraine

Khmelnitckiy regional hospital

Khmelnytsky, , Ukraine

City Clinical Hospital No. 2

Kryvyi Rih, , Ukraine

Medical Center LLC 'Harmony of Beauty'

Kyiv, , Ukraine

Medical Center of 'Institute of Rheumatology', LLC

Kyiv, , Ukraine

Kyiv City Clinical Hospital #3

Kyiv, , Ukraine

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

Kyiv, , Ukraine

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

Kyiv, , Ukraine

Medical Center 'Consylium Medical'

Kyiv, , Ukraine

Volyn Regional Clinical Hospital

Lutsk, , Ukraine

LLC Medical House

Odesa, , Ukraine

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

Poltava, , Ukraine

Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

Vinnytsia, , Ukraine

Medical Center LLC 'Modern Clinic'

Zaporizhzhya, , Ukraine

Countries

United States; Argentina; Australia; Bulgaria; Czechia; Hungary; Israel; Malaysia; Poland; Puerto Rico; Russia; Spain; Turkey (Türkiye); Ukraine

References

Ogdie A, Merola JF, Mease PJ, Ritchlin CT, Scher JU, Lafferty KP, Chan D, Chakravarty SD, Langholff W, Wang Y, Choi O, Krol Y, Gottlieb AB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study. BMC Rheumatol. 2024 May 21;8(1):20. doi: 10.1186/s41927-024-00386-7.

Reference Type: DERIVED

PMID: 38773563 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: INFORMED CONSENT FORM ADDENDUM

View Document

Document Type: Informed Consent Form: MASTER INFORMED CONSENT FORM

View Document

Other Identifiers

CNTO1959PSA3005

Identifier Type: OTHER

Identifier Source: secondary_id

2021-000482-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504715-33-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109039

Identifier Type: -

Identifier Source: org_study_id