A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

— APEX  

Official title:

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882098
• Other study ID #: CR108957
• Secondary ID: 2020-004981-20CN
• Status: Recruiting
• Phase: Phase 3
• Start date: June 17, 2021
• Est. completion date: December 8, 2027

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: December 8, 2027
• Est. primary completion date: January 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy

• Have a diagnosis of 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 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 >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read

• Have at least one 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

Exclusion Criteria:

• Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients

• Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease

• Has previously received any biologic treatment

• Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Guselkumab
Participants will receive guselkumab as SC injection.
• Placebo
Participants will receive matching placebo as SC injection.

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide
Australia	Southern Clinical Research	Hobart
Australia	Eastern Health - Box Hill Hospital	Melbourne
Australia	Emeritus Research	Melbourne
Australia	Rheumatology Research Unit	Sunshine Coast
Bosnia and Herzegovina	University Clinical center Republic of Srpska	Banja Luka
Bosnia and Herzegovina	Health center Gradiska	Gradiska
Bosnia and Herzegovina	Clinical hospital Mostar	Mostar
Bosnia and Herzegovina	Clinical Center University of Sarajevo	Sarajevo
Bulgaria	Medical Center Unimed Plovdiv	Plovdiv
Bulgaria	MHAT Trimantium	Plovdiv
Bulgaria	Multiprofile Hospital for Active Treatment Plovdiv	Plovdiv
Bulgaria	Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv	Plovdiv
Bulgaria	UMHAT Kaspela	Plovdiv
Bulgaria	Medical Center Teodora	Ruse
Bulgaria	Medical Center Medconsult-Pleven	Sevlievo
Bulgaria	DCC Convex EOOD	Sofia
Bulgaria	DCC XVII-Sofia EOOD	Sofia
Bulgaria	Medical Center Hera EOOD	Sofia
Bulgaria	St Ivan Rilski University Multiprofile Hospital For Active Treatment	Sofia
Bulgaria	UMHAT St. Ivan Rilski	Sofia
Bulgaria	UMHAT Sv. Ivan Rilski	Sofia
Canada	Group De Recherche En Rhumatologie Et Maladies Osseuses	Quebec
Canada	Eastern Regional Health Authority, St. Clare's Mercy Hospital	St. John's	Newfoundland and Labrador
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Centre de Recherche Musculo Squelettique	Trois Rivieres	Quebec
China	Affiliated Hospital of Hebei University	Baoding
China	The First Affiliated Hospital of Baotou Medical University	Baotou
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The Affiliated Hospital of Bengbu Medical College	Bengbu
China	The First Bethune Hospital of Jilin University	Changchun
China	Changzhou No 2 Peoples Hospital	Changzhou
China	West China Hospital of Sichuan University	Chengdu
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	the 3rd Affiliated Hospital,Sun Yansen University	Guangzhou
China	The Affiliated Hospital of Guizhou Medical University	Guiyang
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou
China	Linyi City People Hospital	Linyi
China	The First Affiliated Hospital of NanChang University	Nanchang
China	The Second Affiliatde Hospital To Nanchang University	Nanchang
China	Nanjing Drum Tower Hospital	Nanjing
China	Pingxiang People's Hospital	Pingxiang
China	Huashan Hospital Fudan University	Shanghai
China	Shanghai skin disease hospital	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang
China	The hospital of Shanxi Universtidy	Taiyuan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Croatia	Ch Osijek	Osijek
Croatia	KBC Rijeka	Rijeka
Croatia	University Hospital Center Split	Split
Croatia	Klinicki bolnicki centar Zagreb	Zagreb
Croatia	Medicinski centar Kuna & Peric	Zagreb
Croatia	University Hospital Sveti Duh	Zagreb
Czechia	Revmaclinic	Brno
Czechia	Revmatologie s r o	Brno
Czechia	Revmacentrum MUDr Mostera s r o	Brno Zidenice
Czechia	L K N Arthrocentrum	Hlucin
Czechia	CCBR Ostrava s r o	Ostrava
Czechia	MUDr Rosypalova s r o	Ostrava
Czechia	CCBR Klinicka centra Czech, a.s.	Pardubice
Czechia	Fakultni nemocnice v Motole	Prague
Czechia	Affidea - Praha, s.r.o.	Praha
Czechia	CCR Prague s.r.o.	Praha
Czechia	Revmatologicky institut	Praha
Czechia	Revmatologicka ambulance	Praha 4
Czechia	Medical Plus S R O	Uherske Hradiste
Czechia	PV Medical S R O	Zlin
Estonia	North Estonia Medical Centre	Tallinn
Estonia	OU Innomedica	Tallinn
Estonia	Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik	Tartu
Georgia	LTD Unimed Adjara	Batumi
Georgia	LTD Clinic LJ	Kutaisi
Georgia	Aleksandre Aladashvili Clinic LLC	Tbilisi
Georgia	Aleksandre Aladashvili Clinic LLC	Tbilisi
Georgia	Consilium Medulla-multiprofile clinic Ltd	Tbilisi
Georgia	J S C K Eristavi National Cen	Tbilisi
Georgia	JSC Evex Hospitals	Tbilisi
Georgia	LTD MediClub Georgia	Tbilisi
Georgia	Ltd Medicore	Tbilisi
Georgia	LTD The First Medical Center	Tbilisi
Georgia	Raymann Ltd	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic Ltd	Tbilisi
Germany	Rheumatologische Schwerpunktpraxis	Berlin
Germany	Hamburger Rheuma Forschungszentrum II	Hamburg
Germany	Praxis fur Klinische Studien und Praxis fur Orthopadie	Hamburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Institut Fur Praventive Medizin Klinische Forschung GbR	Magdeburg
Germany	Gemeinschaftspraxis Dres. Quist	Mainz
Germany	Rheumazentrum Ratingen	Ratingen
Greece	Hippokration Hospital	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	Naval Hospital of Athens	Athens
Greece	University Hospital Of Larissa, Biopolis	Larissa
Greece	Democritus University of Thrace	Xanthi
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Qualiclinic Kft	Budapest
Hungary	Revita Rendelo	Budapest
Hungary	Uno Medical Trials Ltd.	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Synexus Magyarorszag Kft	Gyula
Hungary	Pest Megyei Flor Ferenc Korhaz	Kistarcsa
Hungary	Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ	Szeged
Hungary	Csongrád Megyei Dr. Bugyi István Kórház	Szentes
Hungary	MAV Korhaz es Rendelointezet	Szolnok
Hungary	Synexus Magyarorszag Kft	Zalaegerszeg
Israel	Barzilai Medical Center	Ashkelon
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center Beilinson Campus	Petah Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania	Catania
Italy	Ospedale San Raffaele, IRCCS	Milano
Italy	AOU Università degli Studi della Campania L. Vanvitelli	Napoli
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Università di Roma La Sapienza	Roma
Italy	Complesso Integrato Columbus	Rome
Italy	A.O.U. Città della Salute e della Scienza	Torino
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan-si
Korea, Republic of	Chonnam National University Hospital	Gwangju-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hanyang University Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Latvia	M & M Centrs Ltd	Adazi
Latvia	J Kisis Ltd	Riga
Latvia	Orto Clinic Ltd	Riga
Latvia	P. Stradina Clinical University Hospital	Riga
Latvia	Riga 1st Hospital	Riga
Lithuania	Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik	Kaunas
Lithuania	Practice Dr Pociene Gilvina	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	Siauliai Republican Hospital, Public Institution	Siauliai
Lithuania	JSC Inlita, Santaros KTC	Vilnius
Malaysia	Hospital Selayang	Batu Caves
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Melaka	Melaka
Malaysia	Sunway Medical Centre	Petaling Jaya, Selangor
Malaysia	Hospital Tuanku Jaafar	Seremban
Philippines	Angeles University Foundation Medical Center	Angeles
Philippines	Cebu Doctors' University Hospital	Cebu
Philippines	De La Salle University Medical Center	Dasmarinas
Philippines	Southern Philippines Medical Center	Davao
Philippines	Davao Doctors Hospital	Davao City
Philippines	Unviersity of Perpetual Help Dalta Medical Center, Inc	Las Pinas
Philippines	Manila Doctors Hospital	Manila
Philippines	Medical Center Manila	Manila
Philippines	Philippine General Hospital	Manila
Poland	ClinicMed Badurski i Wspolnicy Spolka Jawna	Bialystok
Poland	Osteo-Medic s.c A. Racewicz, J Supronik	Bialystok
Poland	Nasz Lekarz Przychodnie Medyczne	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Ambulatorium Barbara Bazela	Elblag
Poland	Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska	Elblag
Poland	Medica Pro Familia sp z o o S K A	Gdynia
Poland	Pratia MCM Krakow	Kraków
Poland	REUMED Zespol Poradni Specjalistycznych Filia nr 2	Lublin
Poland	NZOZ Lecznica Mak-Med sc	Nadarzyn
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Pawel Hrycaj	Poznan
Poland	Nasz Lekarz Przychodnie Medyczne	Torun
Poland	Medycyna Kliniczna	Warsaw
Poland	Reumatika-Centrum Reumatologii, NZOZ	Warszawa
Poland	Rheuma-Medicus, Zaklad Opieki Zdrowotnej	Warszawa
Poland	DERMMEDICA Sp.z o.o.	Wroclaw
Russian Federation	Chelyabinsk Regional Clinical Dermatovenerological Dispensary	Chelyabinsk
Russian Federation	LLC Aliance Biomedical-Ural group	Izhevsk
Russian Federation	State Budgetary Educational Institution of High Professional Education	Kazan
Russian Federation	Medical Center LLC Maxsimum Zdoroviya	Kemerovo
Russian Federation	FGBU Research Institute of Rheumatology named V.A.Nasonova	Moscow
Russian Federation	GU Moscow Regional Research Clinical Institute n.a. M.F.Vla	Moscow
Russian Federation	GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov	Moscow
Russian Federation	LLC Family Outpatient Clinic # 4	Moscow
Russian Federation	LLC Consultative and Diagnostic Center of Rheumatology Heal	Novosibirsk
Russian Federation	GBUZ Orenburg Clinical Regional Hospital	Orenburg
Russian Federation	Republican Hospital n.a.V.A.Baranov	Petrozavodsk
Russian Federation	Ryazan Regional Clinical Cardiology Center	Ryazan
Russian Federation	Ryazan Regional Clinical Dermatovenerological Dispensary	Ryazan
Russian Federation	Ryazan Regional Clinical Hospital	Ryazan
Russian Federation	LLC Sanavita	Sankt-Petersburg.
Russian Federation	Sararov Regional Clinical Hospital	Saratov
Russian Federation	Federal North-West Medical Research Centre	St. Petersburg
Russian Federation	Northen-Western State Medical University n.a. I.I. Mechnikov	St.-Petersburg
Russian Federation	Ulyanovsk Regional Clinical Hospital	Ulyanovsk
Russian Federation	State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital	Vladimir
Russian Federation	Clinical Emergency Hospital n.a. N.V. Solovyev	Yaroslavl
Russian Federation	Clinical Hospital #3	Yaroslavl
Serbia	Institute of Rheumatology	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Serbia	Institute for Treatment and Rehabilitation Niska Banja	Niska Banja
Serbia	Special Hospital for Rheumatic Diseases	Novi Sad
Slovakia	Paediatric University Hospital	Kosice
Slovakia	Reumatologicka ambulancia	Martin
Slovakia	Chiremed, s.r.o.	Puchov
Slovakia	Reumex s.r.o	Rimavska Sobota
Slovenia	Splosna bolnisnica Izola	Izo
Slovenia	Bolnica Dr. Petra Drzaja	Ljubljana
Slovenia	UKC Maribor Dermatology clinic	Maribor
Spain	Hosp. Univ. A Coruna	A Coruna
Spain	Hosp Reina Sofia	Cordoba
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Regional Univ. de Malaga	Malaga
Spain	Hosp. Univ. de Mostoles	Móstoles
Spain	Hosp. Univ. Virgen de La Arrixaca	Murcia
Spain	Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo	Santiago de Compostela
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Nuestra Senora de La Esperanza	Santiago de Compostela
Spain	Hosp. Infanta Luisa	Sevilla
Spain	Hosp. Virgen Macarena	Sevilla
Taiwan	National Taiwan University Hospital	Hsin Chu
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Tao-Yuan
Taiwan	Chi Mei Medical Center Yong Kang	Yung-Kang, Tainan
Turkey	Akdeniz University Medical Faculty	Istanbul
Turkey	Izmir Katip Celebi University	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Selcuk University Medical Faculty	Konya
Ukraine	Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council	Cherkasy
Ukraine	Derzhavna ustanova Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy viddil klinichnoi	Kharkiv
Ukraine	Municipal Institution Regional hospital-center of emergency care and disasters medicine	Kharkiv
Ukraine	Khmelnitska oblasna likarnia	Khmelnitsky
Ukraine	TOV Revmocentr	Kiev
Ukraine	Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady	Kryvyi Rih
Ukraine	Center of Family Medicine Plus LLC	Kyiv
Ukraine	Kyiv Railway Station Clinical Hospital #2	Kyiv
Ukraine	Kyivska oblasna klinichna likarnia	Kyiv
Ukraine	Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud	Kyiv
Ukraine	Olexandrivska Clinical Hospital of Kyiv City	Kyiv
Ukraine	SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine	Kyiv
Ukraine	State Institution Railway clinical Hospital 2	Kyiv
Ukraine	Multidisciplinary Medical Center of Odessa National Medical University	Odessa
Ukraine	Odeska oblasna klinichna likarnia	Odessa
Ukraine	ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil	Poltava
Ukraine	Sumska oblasna klinichna likarnia	Sumy
Ukraine	Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council	Ternopil
Ukraine	Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne]	Vinnytsia
Ukraine	Medical Center LTD Health Clinic Department of Cardiology and Rheumatology	Vinnytsya
Ukraine	Zhytomyr Central City Hospital #1	Zhytomyr
United States	Austin Regional Clinic	Austin	Texas
United States	Rheumatology Associates	Birmingham	Alabama
United States	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	Adriana Pop Moody MD Clinic PA	Corpus Christi	Texas
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Arizona Arthritis and Rheumatology Research PLLC	Flagstaff	Arizona
United States	Arizona Arthritis & Rheumatology Associates PC	Glendale	Arizona
United States	Klein And Associates M D P A	Hagerstown	Maryland
United States	Glacier View Research Institute	Kalispell	Montana
United States	Advanced Medical Research	La Palma	California
United States	Advanced Rheumatology	Lansing	Michigan
United States	Dr. Ramesh Gupta	Memphis	Tennessee
United States	Southwest Rheumatology Research LLC	Mesquite	Texas
United States	Heuer M.D. Research	Orlando	Florida
United States	The Arthritis Center, Inc.	Palm Harbor	Florida
United States	Arthritis Consultants	Saint Louis	Missouri
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Rheumatology Center of San Diego	San Diego	California
United States	STAT Research, Inc.	Springboro	Ohio
United States	Forcare Clinical Research Inc	Tampa	Florida
United States	Arizona Arthritis & Rheumatology Research, PLLC	Tucson	Arizona
United States	Arthritis & Osteoporosis Clinic	Waco	Texas
United States	Medvin Clinical Research, Inc.	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Bosnia and Herzegovina,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Estonia,  Georgia,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Philippines,  Poland,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24	The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).	Week 24
Secondary	Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24	Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.	Baseline and Week 24
Secondary	Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability	Number of Participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.	Up to 168 weeks
Secondary	Number of Participants with AEs leading to Discontinuation of Study Intervention	Number of participants with AEs leading to discontinuation of study intervention will be reported.	Up to 168 weeks
Secondary	Number of Participants with Infections	Number of participants with infections will be reported.	Up to 168 weeks
Secondary	Number of Participants with AEs Temporally Associated With an Injection-site Reactions	Number of participants with AEs temporally associated with an injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 168 weeks
Secondary	Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities	Number of participants with change from baseline in clinical laboratory abnormalities including hematology and chemistry will be reported.	Baseline, up to 168 weeks
Secondary	Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values	Number of participants with maximum CTCAE toxicity grade laboratory values will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.	Up to 168 weeks
Secondary	Serum Guselkumab Concentration	Serum guselkumab concentration will be measured.	Up to 168 weeks
Secondary	Number of Participants with Anti-guselkumab Antibodies	Number of participants with anti-guselkumab antibodies to guselkumab will be reported.	Up to 168 weeks