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

Arthritis, Psoriatic Clinical Trial

— SOLSTICE  

Official title:

A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936308
• Other study ID #: CR109039
• Secondary ID: 2021-000482-32CN
• Status: Recruiting
• Phase: Phase 3
• Start date: September 28, 2021
• Est. completion date: September 7, 2026

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) 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 7, 2026
• Est. primary completion date: December 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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
Argentina	Centro Privado de Medicina Familiar	Buenos Aires
Argentina	Cosultorios Reumatologógicos Pampa	Buenos Aires
Argentina	Hospital Central Militar Cirujano Mayor Dr Cosme Argerich	Buenos Aires
Argentina	CIPREC	Ciudad Autonoma de Buenos Aires
Argentina	OMI	Ciudad Autónoma de Buenos Aires
Argentina	Instituto de Reumatología Mendoza	Ciudad de Mendoza
Argentina	Centro de Investigaciones Medicas Tucuman	San Miguel De Tucuman
Australia	Southern Clinical Research	Hobart
Australia	Liverpool Hospital	Liverpool
Australia	Eastern Health - Box Hill Hospital	Melbourne
Australia	Skin Health Institute Inc.	Melbourne
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	Medical Center Unimed Plovdiv	Plovdiv
Bulgaria	UMHAT Kaspela	Plovdiv
Bulgaria	Diagnosis-consulting centre-1	Ruse
Bulgaria	UMHAT St. Ivan Rilski	Sfia
Bulgaria	ASIMP Rheumatology Centre St Irina EOOD	Sofia
Bulgaria	Medical Centre Synexus	Sofia
Bulgaria	Military Medical Academy	Sofia
Bulgaria	University Multiprofile Hospital Sofiamed Sofia	Sofia
Czechia	RHEUMA s r o	Breclav
Czechia	L K N Arthrocentrum	Hlucin
Czechia	MUDr Rosypalova s r o	Ostrava
Czechia	Arthrohelp S.R.O.	Pardubice
Czechia	Revmatologicky ustav	Praha 2
Czechia	Medical Plus S R O	Uherske Hradiste
Czechia	PV Medical S R O	Zlin
Hungary	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	Szekesfehervar
Hungary	Vital Medical Center Orvosi es Fogaszati Kozpont	Veszprem
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Carmel Medical Center	Hifa
Israel	Meir Medical Center	Kfar-Sava
Israel	Sheba Medical Center	Ramat Gan
Malaysia	Hospital Selayang	Batu Caves
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh
Malaysia	Hospital Tuanku Jaafar	Seremban
Poland	Nzoz Bif Med	Bytom
Poland	Centrum Kliniczno Badawcze	Elblag
Poland	Centrum Medyczne Promed	Krakow
Poland	Malopolskie Badania Kliniczne Sp z o o	Krakow
Poland	Malopolskie Centrum Kliniczne	Krakow
Poland	Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna	Lodz
Poland	Dermed Centrum Medyczne Sp z o o	Lodz
Poland	NZOZ Lecznica MAK MED S C	Nadarzyn
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Centrum Medyczne	Poznan
Poland	Twoja Przychodnia	Poznan
Poland	Lubelskie Centrum Diagnostyczne	Swidnik
Poland	MICS Centrum Medyczne Warszawa	Warsaw
Poland	Centrum Medyczne Reuma Park	Warszawa
Poland	Rheuma-Medicus, Zaklad Opieki Zdrowotnej	Warszawa
Poland	WroMedica I.Bielicka, A.Strzalkowska s.c.	Wroclaw
Puerto Rico	FDI Clinical Research	San Juan
Puerto Rico	GCM Medical Group	San Juan
Puerto Rico	Mindful Medical Research	San Juan
Russian Federation	Altay Medical State University	Barnaul
Russian Federation	Chelyabinck Regional Clinical Hospital	Chelyabinsk
Russian Federation	Chelyabinsk Regional Clinical Dermatovenerological Dispensary	Chelyabinsk
Russian Federation	Kemerovo State Medical University	Kemerovo
Russian Federation	LLL Medical Center Revma-Med	Kemerovo
Russian Federation	LLC Family Outpatient Clinic # 4	Korolev
Russian Federation	Krasnodar Clinical Dermatovenerologic Dispensary	Krasnodar
Russian Federation	Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon	Krasnoyarsk
Russian Federation	Clinical-Diagnostic Center Euromedservice, JSC	Moscow
Russian Federation	FGBU Research Institute of Rheumatology named V.A.Nasonova	Moscow
Russian Federation	GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'	Moscow
Russian Federation	GBOU VPO Orenburg State Medical University	Orenburg
Russian Federation	Rostov Regional Clinical Dermatovenerological Dispensary	Rostov
Russian Federation	Saratov Regional Clinical Hospital	Saratov
Russian Federation	Smolensk regional hospital on Smolensk railway station	Smolensk
Russian Federation	St. Petersburg GBUZ Clinical Reumatological Hospital 25	St. Petersburg
Russian Federation	X7 Clinical Research Company Limited	St. Petersburg
Russian Federation	GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'	Tolyatti
Russian Federation	Tula Regional Clinical Dermatovenerological Dispensary	Tula
Russian Federation	Republican Clinical Hospital - G.G. Kuvatov	Ufa
Spain	Hosp. Univ. de Cruces	Barakaldo
Spain	Hosp. Quiron Madrid Pozuelo	Madrid
Spain	Hosp. Univ. de La Princesa	Madrid
Spain	Hosp. Regional Univ. de Malaga	Málaga
Spain	Clinica Gaias	Santiago de Compostela
Spain	Hosp. Quiron Sagrado Corazon	Sevilla
Spain	Hosp. Clinico Univ. de Valencia	Valencia
Turkey	Adana City Hospital	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Gulhane Training and Research Hospital	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Uludag University Medical Faculty	Bursa
Turkey	Pamukkale University Medical Faculty	Denizli
Turkey	Osmangazi University Medical Faculty	Eskisehir
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Istanbul University Istanbul Medical Faculty	Istanbul
Turkey	Kartal Dr Lutfi Kirdar sehir Hastanesi	Istanbul
Turkey	Marmara University Medical Faculty	Istanbul
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Necmettin Erbakan University Meram Medical Faculty	Konya
Ukraine	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	Kyiv City Clinical Hospital #3	Kyiv
Ukraine	Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'	Kyiv
Ukraine	Medical Center 'Consylium Medical'	Kyiv
Ukraine	Medical Center LLC 'Harmony of Beauty'	Kyiv
Ukraine	Medical Center of 'Institute of Rheumatology', LLC	Kyiv
Ukraine	SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine	Kyiv
Ukraine	Volyn Regional Clinical Hospital	Lutsk
Ukraine	LLC Medical House	Odessa
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	Vinnytsya
Ukraine	Medical Center LLC 'Modern Clinic'	Zaporizhzhya
United States	Albuquerque Center for Rheumatology	Albuquerque	New Mexico
United States	Johns Hopkins University	Baltimore	Maryland
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	Rheumatology and Pulmonary Clinic	Beckley	West Virginia
United States	Rheumatology Associates	Birmingham	Alabama
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Clinical Research of West Florida	Clearwater	Florida
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	Clinical Research Center of Connecticut	Danbury	Connecticut
United States	Omega Research Consultants	DeBary	Florida
United States	St. Paul Rhuematology P A	Eagan	Minnesota
United States	Arizona Arthritis and Rheumatology Research PLLC	Flagstaff	Arizona
United States	Precision Comprehensive Clinical Research Solutions	Fort Worth	Texas
United States	Klein And Associates M D P A	Hagerstown	Maryland
United States	Newport Huntington Medical Group	Huntington Beach	California
United States	Great Lakes Center of Rheumatology	Lansing	Michigan
United States	Arthritis and Osteoperosis Associates of New Mexico	Las Cruces	New Mexico
United States	West Texas Clinical Research	Lubbock	Texas
United States	Dr. Ramesh Gupta	Memphis	Tennessee
United States	Arizona Arthritis and Rheumatology Research PLLC	Mesa	Arizona
United States	Southwest Rheumatology Research LLC	Mesquite	Texas
United States	The Arthritis and Diabetes Clinic	Monroe	Louisiana
United States	Advanced Clinical Research of Orlando	Ocoee	Florida
United States	Arthritis and Rheumatology Center of MI	Okemos	Michigan
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Rheumatology Associates of Oklahoma	Oklahoma City	Oklahoma
United States	Buffalo Rheumatology and Medicine PLLC	Orchard Park	New York
United States	Arizona Arthritis and Rheumatology Research PLLC	Phoenix	Arizona
United States	Arizona Arthritis and Rheumatology Research PLLC	Phoenix	Arizona
United States	Texas Rheumatology Care	Plano	Texas
United States	Integral Rheumatology And Immunology Specialists	Plantation	Florida
United States	Clinical Research Institute of Michigan, LLC	Saint Clair Shores	Michigan
United States	Arthritis Consultants	Saint Louis	Missouri
United States	Unity Health-White County Medical Center	Searcy	Arkansas
United States	Clinic of Robert Hozman	Skokie	Illinois
United States	Arthritis Northwest PLLC	Spokane	Washington
United States	Arizona Arthritis and Rheumatology Associates	Sun City	Arizona
United States	Clinical Research of West Florida	Tampa	Florida
United States	Advanced Rheumatology of Houston	The Woodlands	Texas
United States	Medvin Clinical Research	Thousand Oaks	California
United States	DM Clinical Research	Tomball	Texas
United States	Southern Arizona VA Healthcare System	Tucson	Arizona
United States	Medvin Clinical Research	Tujunga	California
United States	STAT Research, Inc.	Vandalia	Ohio
United States	Arthritis Rheumatic And Back Disease Associates	Voorhees	New Jersey
United States	Arthritis & Osteoporosis Clinic	Waco	Texas
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Czechia,  Hungary,  Israel,  Malaysia,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieve 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 from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent (%) improvement from baseline 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 CRP.	Week 24
Secondary	Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline	Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 (cleared) or 1 (minimal) and >=2- grade reduction from baseline. The IGA documents the investigator's assessment of the participants psoriasis and lesions are graded for induration, erythema and scaling, each using a 5-point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	Week 24
Secondary	Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline	Psoriasis Area and Severity Index (PASI) is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area is assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.	Week 24
Secondary	Change From Baseline in HAQ-DI Score at Week 24	HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.	Baseline and Week 24
Secondary	Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24	SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a PCS with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.	Baseline and Week 24
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24	The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score is calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.	Baseline and Week 24
Secondary	Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24	MDA is considered achieved if at least 5 of the following 7 criteria were met at the analysis visit: tender joint count <=1; swollen joint count <=1; psoriasis activity and severity index <=1; patient's pain VAS score of <=15; patient's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1.	Week 24
Secondary	Percentage of Participants who Achieve ACR 20 Response at Week 16	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=indicating no difficulty, 3=indicating inability to perform task in that area), and CRP.	Week 16
Secondary	Percentage of Participants who Achieve ACR 50 Response at Week 16	ACR 50 response is defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% 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 the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.	Week 16
Secondary	Percentage of Participants who Achieve ACR 50 Response at Week 24	ACR 50 response is defined as >=50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% 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 the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.	Week 24
Secondary	Percentage of Participants who Achieve ACR 70 Response at Week 24	ACR 70 response is defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% 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 the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.	Week 24
Secondary	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability	Percentage 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 112 weeks
Secondary	Percentage of Participants With AEs leading to Discontinuation of Study Intervention	Percentage of participants with AEs leading to discontinuation of study intervention will be reported.	Up to 112 weeks
Secondary	Percentage of Participants With Infections	Percentage of participants with infections will be reported.	Up to 112 weeks
Secondary	Percentage of Participants With Injection-site Reactions	Percentage of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.	Up to 100 weeks
Secondary	Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities	Percentage of participants with change from baseline in clinical laboratory abnormalities including chemistry and hematology will be reported.	Up to 112 weeks
Secondary	Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity	Percentage of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades as per CTCAE 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 112 weeks
Secondary	Serum Guselkumab Concentration	Serum guselkumab concentration will be measured.	Up to 112 weeks
Secondary	Percentage of Participants With Anti-guselkumab Antibodies	Percentage of participants with anti-guselkumab antibodies to guselkumab will be reported.	Up to 112 weeks