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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthritis, Psoriatic
• Intervention / Treatment: Drug: Placebo; Drug: Guselkumab

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.

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1417EYG
    • Centro Privado de Medicina Familiar
  • Buenos Aires, Argentina, C1426BOS
    • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
  • Buenos Aires, Argentina, 1428
    • Cosultorios Reumatologógicos Pampa
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Buenos Aires, Argentina, C1015ABO
    • OMI
  • Mendoza, Argentina, M5631AHF
    • Instituto de Reumatología Mendoza
  • San Miguel de Tucumán, Argentina, T4000AXL
    • Centro de Investigaciones Medicas Tucuman
• Australia
  • Hobart, Australia, 7000
    • Southern Clinical Research
  • Liverpool, Australia, 2170
    • Liverpool Hospital
  • Melbourne, Australia, 3128
    • Eastern Health - Box Hill Hospital
  • Melbourne, Australia, 3053
    • Skin Health Institute Inc.
• Bulgaria
  • Pleven, Bulgaria, 5804
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela
  • Plovdiv, Bulgaria, 4001
    • Medical Center Unimed Plovdiv
  • Rousse, Bulgaria, 7002
    • Diagnosis-consulting centre-1
  • Sofia, Bulgaria, 1606
    • Military Medical Academy
  • Sofia, Bulgaria, 1794
    • Medical Centre Synexus
  • Sofia, Bulgaria, 1612
    • UMHAT St. Ivan Rilski
  • Sofia, Bulgaria, 1750
    • ASIMP Rheumatology Centre St Irina EOOD
  • Sofia, Bulgaria, 1770
    • University Multiprofile Hospital Sofiamed Sofia
• Czechia
  • Břeclav, Czechia, 690 02
    • RHEUMA s r o
  • Hlučín, Czechia, 748 01
    • L K N Arthrocentrum
  • Ostrava, Czechia, 70800
    • MUDr Rosypalova s r o
  • Pardubice, Czechia, 53002
    • Arthrohelp S.R.O.
  • Prague, Czechia, 128 50
    • Revmatologicky Ustav
  • Uherské Hradiště, Czechia, 68601
    • Medical Plus S R O
  • Zlín, Czechia, 76001
    • PV Medical S R O
• Hungary
  • Budapest, Hungary, 1152
    • Uno Medical Trials Ltd.
  • Budapest, Hungary, 1027
    • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Kistarcsa, Hungary, 2143
    • Pest Megyei Flor Ferenc Korhaz
  • Szeged, Hungary, 6725
    • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
  • Székesfehérvár, Hungary, H-8000
    • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
  • Veszprém, Hungary, 8200
    • Vital Medical Center Orvosi es Fogaszati Kozpont
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Haifa, Israel, 34362
    • Carmel Medical Center
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center
• Malaysia
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • George Town, Malaysia, 10990
    • Hospital Pulau Pinang
  • Ipoh, Malaysia, 30450
    • Hospital Raja Permaisuri Bainun
  • Seremban, Malaysia, 70300
    • Hospital Tuanku Jaafar
• Poland
  • Bytom, Poland, 41 902
    • Nzoz Bif Med
  • Elblag, Poland, 82-300
    • Centrum Kliniczno Badawcze
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed
  • Krakow, Poland, 30 149
    • Malopolskie Centrum Kliniczne
  • Krakow, Poland, 30 002
    • Malopolskie Badania Kliniczne Sp z o o
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Lodz, Poland, 90-265
    • Dermed Centrum Medyczne Sp z o o
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica MAK MED S C
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Poznan, Poland, 61 113
    • Centrum Medyczne
  • Poznan, Poland, 60 324
    • Twoja Przychodnia PCM
  • Warsaw, Poland, 00-874
    • MICS Centrum Medyczne Warszawa
  • Warsaw, Poland, 02 118
    • Rheuma Medicus Sp z o o
  • Warsaw, Poland, 02 665
    • Centrum Medyczne Reuma Park
  • Wroclaw, Poland, 51 685
    • WroMedica I Bielicka A Strzalkowska s c
  • Świdnik, Poland, 21 040
    • Lubelskie Centrum Diagnostyczne
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Mindful Medical Research
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research
  • San Juan, Puerto Rico, 00917
    • GCM Medical Group
• Russia
  • Barnaul, Russia, 656038
    • Altay Medical State University
  • Chelyabinsk, Russia, 454076
    • Chelyabinck Regional Clinical Hospital
  • Chelyabinsk, Russia, 454092
    • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
  • Kemerovo, Russia, 650000
    • Kemerovo State Medical University
  • Kemerovo, Russia, 650070
    • LLL Medical Center Revma-Med
  • Korolyov, Russia, 141060
    • LLC Family Outpatient Clinic # 4
  • Krasnodar, Russia, 350020
    • Krasnodar Clinical Dermatovenerologic Dispensary
  • Krasnoyarsk, Russia, 660123
    • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
  • Moscow, Russia, 115419
    • Clinical-Diagnostic Center Euromedservice, JSC
  • Moscow, Russia, 115522
    • FGBU Research Institute of Rheumatology named V.A.Nasonova
  • Moscow, Russia, 129110
    • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
  • Orenburg, Russia, 460000
    • GBOU VPO Orenburg State Medical University
  • Rostov-on-Don, Russia, 344007
    • Rostov Regional Clinical Dermatovenerological Dispensary
  • Saint Petersburg, Russia, 190068
    • St. Petersburg GBUZ Clinical Reumatological Hospital 25
  • Saint Petersburg, Russia, 194156
    • X7 Clinical Research Company Limited
  • Saratov, Russia, 410053
    • Saratov Regional Clinical Hospital
  • Smolensk, Russia, 214025
    • Smolensk regional hospital on Smolensk railway station
  • Tolyatti, Russia, 445846
    • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
  • Tula, Russia, 300053
    • Tula Regional Clinical Dermatovenerological Dispensary
  • Ufa, Russia, 450005
    • Republican Clinical Hospital - G.G. Kuvatov
• Spain
  • Barakaldo, Spain, 48903
    • Hosp. Univ. de Cruces
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28223
    • Hosp. Quiron Madrid Pozuelo
  • Málaga, Spain, 29011
    • Hosp Regional Univ de Malaga
  • Santiago de Compostela, Spain, 15702
    • Clinica Gaias
  • Seville, Spain, 41013
    • Hosp. Quiron Sagrado Corazon
  • Valencia, Spain, 46010
    • Hosp. Clinico Univ. de Valencia
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Adana City Hospital
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent City Hospital
  • Ankara, Turkey (Türkiye), 6100
    • Hacettepe University Medical Faculty
  • Ankara, Turkey (Türkiye), 06010
    • Gulhane Egitim ve Arastirma Hastanesi
  • Antalya, Turkey (Türkiye), 07070
    • Akdeniz Universitesi Hastanesi
  • Bursa, Turkey (Türkiye), 16059
    • Bursa Uludag Universitesi Hastanesi
  • Denizli, Turkey (Türkiye), 20070
    • Pamukkale University Medical Faculty
  • Eskişehir, Turkey (Türkiye), 26040
    • Osmangazi University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34865
    • Kartal Dr Lutfi Kirdar Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul University Istanbul Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Istanbul, Turkey (Türkiye), 34899
    • Marmara University Medical Faculty
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Medical Faculty
  • Konya, Turkey (Türkiye), 42090
    • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Kharkiv, Ukraine, 61204
    • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Khmelnytsky, Ukraine, 29000
    • Khmelnitckiy regional hospital
  • Kryvyi Rih, Ukraine, 50056
    • City Clinical Hospital No. 2
  • Kyiv, Ukraine, 03049
    • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • Kyiv, Ukraine, 04050
    • Medical Center 'Consylium Medical'
  • Kyiv, Ukraine, 02125
    • Kyiv City Clinical Hospital #3
  • Kyiv, Ukraine, 01135
    • Medical Center LLC 'Harmony of Beauty'
  • Kyiv, Ukraine, 02081
    • Medical Center of 'Institute of Rheumatology', LLC
  • Kyiv, Ukraine, 03151
    • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Lutsk, Ukraine, 43005
    • Volyn Regional Clinical Hospital
  • Odesa, Ukraine, 65026
    • LLC Medical House
  • Poltava, Ukraine, 36011
    • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • Vinnytsia, Ukraine, 21018
    • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
  • Zaporizhzhya, Ukraine, 69600
    • Medical Center LLC 'Modern Clinic'
• United States
  • Alabama
    • Mountain Brook, Alabama, United States, 35223
      • Arthritis Associates
  • Arizona
    • Avondale, Arizona, United States, 85392
      • Arizona Arthritis and Rheumatology Research PLLC 2
    • Flagstaff, Arizona, United States, 86001-6218
      • Arizona Arthritis and Rheumatology Research PLLC 3
    • Mesa, Arizona, United States, 85210
      • Arizona Arthritis and Rheumatology Research PLLC
    • Phoenix, Arizona, United States, 85032
      • Arizona Arthritis and Rheumatology Research PLLC 1
    • Sun City, Arizona, United States, 85351
      • Arizona Arthritis and Rheumatology Associates
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Healthcare System
  • Arkansas
    • Searcy, Arkansas, United States, 72143
      • Unity Health-White County Medical Center
  • California
    • Huntington Beach, California, United States, 92648
      • Newport Huntington Medical Group
    • Thousand Oaks, California, United States, 91360
      • Medvin Clinical Research 2
    • Tujunga, California, United States, 91042
      • Medvin Clinical Research
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Clinical Research Center of Connecticut
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA Healthcare System
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • DeBary, Florida, United States, 32713
      • Omega Research Consultants
    • Ocoee, Florida, United States, 34761
      • Advanced Clinical Research of Orlando
    • Plantation, Florida, United States, 33324
      • Integral Rheumatology and Immunology Specialists
    • Tampa, Florida, United States, 33606
      • Clinical Research of West Florida 1
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, P.A.
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Skokie, Illinois, United States, 60076
      • Clinic of Robert Hozman
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • The Arthritis and Diabetes Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
    • Hagerstown, Maryland, United States, 21740
      • Klein And Associates M D P A
  • Michigan
    • Lansing, Michigan, United States, 48911
      • Great Lakes Center of Rheumatology
    • Okemos, Michigan, United States, 48864
      • Arthritis and Rheumatology Center of MI
    • Saint Clair Shores, Michigan, United States, 48081
      • Clinical Research Institute of Michigan, LLC
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rheumatology P A
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Arthritis Consultants
  • New Jersey
    • Voorhees Township, New Jersey, United States, 08043
      • Arthritis Rheumatic And Back Disease Associates
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Center for Rheumatology
    • Las Cruces, New Mexico, United States, 88011
      • Arthritis and Osteoperosis Associates of New Mexico
  • New York
    • Orchard Park, New York, United States, 14127
      • Buffalo Rheumatology and Medicine PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • DJL Clinical Research, PLLC
  • Ohio
    • Vandalia, Ohio, United States, 45377
      • STAT Research, Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Health Research of Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Rheumatology Associates of Oklahoma
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Dr. Ramesh Gupta
  • Texas
    • Colleyville, Texas, United States, 76034
      • Precision Comprehensive Clinical Research Solutions
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop Moody MD Clinic PA
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Fort Worth, Texas, United States, 76107
      • Precision Comprehensive Clinical Research Solutions 1
    • Lubbock, Texas, United States, 79424
      • West Texas Clinical Research
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology Research LLC
    • Plano, Texas, United States, 75024
      • Texas Rheumatology Care
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
    • Waco, Texas, United States, 76710
      • Arthritis And Osteoporosis Clinic
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest PLLC 1
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology and Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Guselkumab and Placebo; Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.	Drug: Placebo; Participants will receive matching placebo as SC injection.; Drug: Guselkumab; Participants will receive guselkumab as SC injection.; Other Names: Tremfya; CNTO1959
Experimental: Group 2: Guselkumab; Participants will receive guselkumab SC.	Drug: Guselkumab; Participants will receive guselkumab as SC injection.; Other Names: Tremfya; CNTO1959
Experimental: Group 3: Placebo Followed by Guselkumab; Participants will receive placebo SC and will cross over to receive guselkumab SC.	Drug: Placebo; Participants will receive matching placebo as SC injection.; Drug: Guselkumab; Participants will receive guselkumab as SC injection.; Other Names: Tremfya; CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved a Psoriasis Response of Investigator's Global Assessment (IGA) Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among the Participants With >=3 Percent(%) Body Surface Area (BSA)	A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and greater than equal to (>=2) grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's 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 was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).	At Week 24
Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline	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 was 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 severtiy. 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.	At Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24	The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 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 (pre dose Week 0) and Week 24
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 Physical Component Summary (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 (pre dose Week 0) and Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24	The FACIT-Fatigue 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 was 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 were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.	Baseline (pre dose Week 0) and Week 24
Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Week 24	MDA is a measure that defines a satisfactory state of disease activity that includes 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity on arthritis and psoriasis, physical function and enthesitis). Participants were classified as achieving MDA if they fulfilled 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).	At Week 24
Percentage of Participants Who Achieved 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= no difficulty, 3= inability to perform task in that area), and CRP.	At Week 16
Percentage of Participants Who Achieved ACR 50 Response at Week 16	ACR 50 response: >=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 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.	At Week 16
Percentage of Participants Who Achieved ACR 50 Response at Week 24	ACR 50 response: >=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 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.	At Week 24
Percentage of Participants Who Achieved ACR 70 Response at Week 24	ACR 70 response: >=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 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.	At Week 24
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)		From first administration of study drug (Week 0) up to Week 112
Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs)		From first administration of study drug (Week 0) up to Week 112
Percentage of Participants With Treatment Emergent Related AEs (TERAEs)		From first administration of study drug (Week 0) up to Week 112
Treatment Emergent AEs Leading to Discontinuation of Study Intervention		From first administration of study drug (Week 0) up to Week 112
Percentage of Participants With Infections		From first administration of study drug (Week 0) up to Week 112
Percentage of Participants With Injection-site Reactions		From first administration of study drug (Week 0) up to Week 112
Percentage of Participants With Infusion Related Reactions		From first administration of study drug (Week 0) up to Week 112
Number of Participants With Post-baseline Laboratory Abnormalities With Maximum Toxicity Grade Greater Than or Equal to >=3 Based on Common Terminology Criteria for Adverse Events (CTCAE)		From first administration of study drug (Week 0) up to Week 112
Serum Guselkumab Concentration Over Time	Serum concentrations of guselkumab over time was reported.	At Weeks 0, 4, 8, 12, 16, 20,and 24
Number of Participants With Antibodies to Guselkumab	Number of participants with antibodies to guselkumab (ADA) were reported. A validated immunoassay was used to detect ADA.	Baseline (pre dose Week 0) up to Week 24

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): October 28, 2024
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic; Substandard Drugs; Pharmaceutical Preparations; guselkumab
• Other Study ID Numbers: CR109039; 2021-000482-32 (EudraCT Number); CNTO1959PSA3005 (Other Identifier: Janssen Research & Development, LLC); 2023-504715-33-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No