A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

NCT03162796 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1082182016-001163-37CNTO1959PSA3001
• Study Type: interventional
• Target: 383
• Locations: 13 countries
• Sites: 95

Brief Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

  ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

  Week 24

Secondary Outcomes (99)

• Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

  Baseline and Week 24

• Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24

  Week 24

• Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline

  Week 24

• Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16

  Week 16

• Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24

  Baseline and Week 24

Study Arms (3)

Group 1: Guselkumab

EXPERIMENTAL

Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 48.

Drug: Guselkumab

Group 2: Guselkumab and Placebo

EXPERIMENTAL

Participants will receive SC guselkumab 100 mg at Weeks 0 and 4, then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, and 44) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48) to maintain the blind.

Drug: Guselkumab; Drug: Placebo

Group 3: Placebo Followed by Guselkumab

EXPERIMENTAL

Participants will receive SC placebo q4w from Week 0 to Week 20, and will crossover at Week 24 to receive guselkumab 100 mg q4w from Week 24 through Week 48.

Drug: Guselkumab; Drug: Placebo

Interventions

Guselkumab DRUG

Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.

Also known as: CNTO 1959

Group 1: Guselkumab; Group 2: Guselkumab and Placebo; Group 3: Placebo Followed by Guselkumab

Placebo DRUG

Participants will receive matching placebo as SC injection.

Group 2: Guselkumab and Placebo; Group 3: Placebo Followed by Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of 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 milligram per deciLitre (mg/dL) at screening from the central laboratory
• Have at least 1 of the 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 or documented history of plaque psoriasis
• Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
• Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent \[%\] of the overall study population), and must document the reason for discontinuation

You may not qualify if:

• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
• Has ever received more than 2 anti-TNFalpha agents
• Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
• Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
• Has received apremilast within 4 weeks prior to the first administration of study agent
• Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (95)

Rheumatology Associates

Birmingham, Alabama, 35205, United States

Location

Arizona Arthritis & Rheumatology Associates PC

Glendale, Arizona, 85306, United States

Location

Arizona Arthritis & Rheumatology Research, PLLC

Mesa, Arizona, 85210, United States

Location

Clinical Research Center of Connecticut

Danbury, Connecticut, 06810, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256-4697, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Arthritis Consultants

St Louis, Missouri, 63141, United States

Location

Arthritis and Osteoporosis Associates

Freehold, New Jersey, 07728, United States

Location

Austin Regional Clinic

Austin, Texas, 78731-3146, United States

Location

Barwon Rheumatology Services

Geelong, 3220, Australia

Location

Southern Clinical Research

Hobart, 7000, Australia

Location

Liverpool Hospital

Liverpool, 2170, Australia

Location

Rheumatology Research Unit

Maroochydore, 4558, Australia

Location

Eastern Health - Box Hill Hospital

Melbourne, 3128, Australia

Location

Queen Elizabeth Hospital

Woodville South, 5011, Australia

Location

Eastern Regional Health Authority, St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

The Waterside Clinic

Barrie, Ontario, L4M 6L2, Canada

Location

Dermatrials Research

Hamilton, Ontario, L8N 1Y2, Canada

Location

Skin Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4, Canada

Location

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

Québec, G1V 3M7, Canada

Location

Revmaclinic

Brno, 61141, Czechia

Location

MUDr. Rosypalova, s.r.o

Ostrava, 70800, Czechia

Location

Revmatologicky ustav

Prague, 12850, Czechia

Location

Revmatologicka ambulance

Prague, 14000, Czechia

Location

Medical Plus S.R.O.

Uherské Hradiště, 68601, Czechia

Location

PV-Medical S.R.O

Zlín, 76001, Czechia

Location

ISA GmbH

Berlin, 10789, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

MVZ Rheuma

Hamburg, 20095, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Krankenhaus St. Josef

Wuppertal, 42105, Germany

Location

Orszagos Reumatologia es Fizioterapias Intezet

Budapest, 1023, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, 2143, Hungary

Location

Martinus Medicus Health Center

Szombathely, 9700, Hungary

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

Hospital Pulau Pinang

George Town, 10990, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30990, Malaysia

Location

Hospital Melaka

Malacca, 75400, Malaysia

Location

Hospital Tuanku Jaafar

Seremban, 70300, Malaysia

Location

Nzoz Osteo-Medic

Bialystok, 15-351, Poland

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

NSZOZ Unica CR

Dąbrówka, 62-069, Poland

Location

Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

Elblag, 82-300, Poland

Location

Etyka Osrodek Badan Klinicznych

Olsztyn, 10-117, Poland

Location

Centrum Medyczne Hetmańska

Poznan, 60-218, Poland

Location

Nasz Lekarz Przychodnie Medyczne

Torun, 87-100, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, 02-637, Poland

Location

Centrum Medyczne WroMedica

Wroclaw, 51-685, Poland

Location

Nzoz Biogenes Sp. Z O. O.

Wroclaw, 53-224, Poland

Location

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

Chelyabinsk, 454092, Russia

Location

Medical and Sanitary Unit ''Severstal''

Cherepovets, 162600, Russia

Location

Krasnoyarsk State Medical University

Krasnoyarsk, 660022, Russia

Location

Lipetsk Regional Dermatovenerological Dispensary

Lipetsk, 398005, Russia

Location

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, 344007, Russia

Location

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, 390046, Russia

Location

Republican Clinical Hospital - G.G. Kuvatov

Ufa, 450005, Russia

Location

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

Yaroslavl, 150003, Russia

Location

Clinical Hospital #10

Yaroslavl, 150023, Russia

Location

Research Institute of Dermatovenerology, Immunology

Yekaterinburg, 620076, Russia

Location

Seoul National University Bundang Hospital

Bundang, 13620, South Korea

Location

Hanyang University Hospital for rheumatic Diseases

Seoul, 04763, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

SMG - SNU Boramae Medical Center

Seoul, 7061, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Hosp. Univ. A Coruña

A Coruña, 15006, Spain

Location

Hosp. Del Mar

Barcelona, 08003, Spain

Location

Hosp. Gral. Univ. Gregorio Marañon

Madrid, 28007, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hospital Regional Carlos Haya

Málaga, 29009, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Infanta Luisa

Seville, 41010, Spain

Location

Hosp. Unv. de Valme

Seville, 414014, Spain

Location

Hosp. de Manises

Valencia, 46940, Spain

Location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Chang Gung Memorial Hospital Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

National Cheng Kung University Medical Center

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Kung Memorial Hospital

Taipei, 105, Taiwan

Location

Chang-Gung Memorial Hospital, LinKou Branch

Taoyuan District, 333, Taiwan

Location

Municipal health care institution Chernihiv Regional Hospital

Chernihiv, Ukraine

Location

Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

Ivano-Frankivsk, Ukraine

Location

Communal Institution of Health Kharkiv City multifield hospital №18

Kharkiv, 61029, Ukraine

Location

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

Kharkiv, Ukraine

Location

Khmelnitckiy regional hospital

Khmelnytsky, Ukraine

Location

Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'

Kyiv, Ukraine

Location

Kyiv Railway Station Clinical Hospital #2

Kyiv, Ukraine

Location

Danylo Halytsky Lviv National Medical University

Lviv, Ukraine

Location

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

Odesa, 65025, Ukraine

Location

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Ternopil, Ukraine

Location

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• Gladman DD, Eder L, Selmi C, Mease PJ, Ogdie A, Lozenski K, Adamson E, Sharaf M, Rampakakis E, Pina Vegas L, Coates LC. Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials. Rheumatol Ther. 2025 Dec 15. doi: 10.1007/s40744-025-00812-3. Online ahead of print.

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• Mease P, Korotaeva T, Shesternya P, Kokhan M, Rukavitsyn A, Vasilchenkov D, Sharaf M, Lavie F, Deodhar A. Guselkumab in Biologic-Naive Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials. Rheumatol Ther. 2024 Dec;11(6):1551-1567. doi: 10.1007/s40744-024-00713-x. Epub 2024 Sep 25.

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• Curtis JR, Deodhar A, Soriano ER, Rampakakis E, Shawi M, Shiff NJ, Han C, Tillett W, Gladman DD. Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials. Rheumatol Ther. 2024 Dec;11(6):1501-1517. doi: 10.1007/s40744-024-00702-0. Epub 2024 Sep 11.

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• Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

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• Kavanaugh A, Baraliakos X, Gao S, Chen W, Sweet K, Chakravarty SD, Song Q, Shawi M, Rahman P. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials. Adv Ther. 2023 May;40(5):2439-2456. doi: 10.1007/s12325-023-02475-4. Epub 2023 Mar 30.

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• Orbai AM, Coates LC, Deodhar A, Helliwell PS, Ritchlin CT, Leibowitz E, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Jiang Y, Liu Y, Han C. Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study. Patient. 2022 Nov;15(6):657-668. doi: 10.1007/s40271-022-00588-6. Epub 2022 Jun 30.

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• Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Schiopu E, Chakravarty SD, Kollmeier AP, Xu XL, Shawi M, Jiang Y, Sheng S, Wang Y, Xu S, Merola JF, McInnes IB, Deodhar A. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022 Mar;8(1):e002195. doi: 10.1136/rmdopen-2022-002195.

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• McGonagle D, McInnes IB, Deodhar A, Schett G, Shawi M, Kafka S, Karyekar CS, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Ritchlin CT, Rahman P, Mease PJ. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies. Rheumatology (Oxford). 2021 Nov 3;60(11):5337-5350. doi: 10.1093/rheumatology/keab285.

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MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Head Rheumatology Clinical Development
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: August 24, 2017
• Primary Completion: March 14, 2019
• Study Completion: November 18, 2019
• Last Updated: February 3, 2021
• Results First Posted: October 14, 2020

Record last verified: 2021-01

Locations

UA (10); KR (5); US (9); AU (6); CZ (6); HU (5); MY (5); CA (6); PL (11); ES (9); DE (5); RU (10); TW (8)