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
4 other identifiers
interventional
453
14 countries
169
Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2021
Longer than P75 for phase_3
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2024
CompletedResults Posted
Study results publicly available
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2026
ExpectedApril 13, 2026
April 1, 2026
3.1 years
June 16, 2021
October 27, 2025
April 9, 2026
Conditions
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.
At Week 24
Secondary Outcomes (20)
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)
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
At Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
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
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
Baseline (pre dose Week 0) and Week 24
- +15 more secondary outcomes
Study Arms (3)
Group 1: Guselkumab and Placebo
EXPERIMENTALParticipants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Group 2: Guselkumab
EXPERIMENTALParticipants will receive guselkumab SC.
Group 3: Placebo Followed by Guselkumab
EXPERIMENTALParticipants will receive placebo SC and will cross over to receive guselkumab SC.
Interventions
Participants will receive guselkumab as SC injection.
Participants will receive matching placebo as SC injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (169)
Arthritis Associates
Mountain Brook, Alabama, 35223, United States
Arizona Arthritis and Rheumatology Research PLLC 2
Avondale, Arizona, 85392, United States
Arizona Arthritis and Rheumatology Research PLLC 3
Flagstaff, Arizona, 86001-6218, United States
Arizona Arthritis and Rheumatology Research PLLC
Mesa, Arizona, 85210, United States
Arizona Arthritis and Rheumatology Research PLLC 1
Phoenix, Arizona, 85032, United States
Arizona Arthritis and Rheumatology Associates
Sun City, Arizona, 85351, United States
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723, United States
Unity Health-White County Medical Center
Searcy, Arkansas, 72143, United States
Newport Huntington Medical Group
Huntington Beach, California, 92648, United States
Medvin Clinical Research 2
Thousand Oaks, California, 91360, United States
Medvin Clinical Research
Tujunga, California, 91042, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Omega Research Consultants
DeBary, Florida, 32713, United States
Advanced Clinical Research of Orlando
Ocoee, Florida, 34761, United States
Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324, United States
Clinical Research of West Florida 1
Tampa, Florida, 33606, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Clinic of Robert Hozman
Skokie, Illinois, 60076, United States
The Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Klein And Associates M D P A
Hagerstown, Maryland, 21740, United States
Great Lakes Center of Rheumatology
Lansing, Michigan, 48911, United States
Arthritis and Rheumatology Center of MI
Okemos, Michigan, 48864, United States
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081, United States
St. Paul Rheumatology P A
Eagan, Minnesota, 55121, United States
Arthritis Consultants
St Louis, Missouri, 63141, United States
Arthritis Rheumatic And Back Disease Associates
Voorhees Township, New Jersey, 08043, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteoperosis Associates of New Mexico
Las Cruces, New Mexico, 88011, United States
Buffalo Rheumatology and Medicine PLLC
Orchard Park, New York, 14127, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28211, United States
STAT Research, Inc.
Vandalia, Ohio, 45377, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Rheumatology Associates of Oklahoma
Oklahoma City, Oklahoma, 73116, United States
Dr. Ramesh Gupta
Memphis, Tennessee, 38119, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034, United States
Adriana Pop Moody MD Clinic PA
Corpus Christi, Texas, 78404, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Precision Comprehensive Clinical Research Solutions 1
Fort Worth, Texas, 76107, United States
West Texas Clinical Research
Lubbock, Texas, 79424, United States
Southwest Rheumatology Research LLC
Mesquite, Texas, 75150, United States
Texas Rheumatology Care
Plano, Texas, 75024, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Arthritis And Osteoporosis Clinic
Waco, Texas, 76710, United States
Arthritis Northwest PLLC 1
Spokane, Washington, 99204, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, 25801, United States
Cosultorios Reumatologógicos Pampa
Buenos Aires, 1428, Argentina
OMI
Buenos Aires, C1015ABO, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Centro Privado de Medicina Familiar
Buenos Aires, C1417EYG, Argentina
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires, C1426BOS, Argentina
Instituto de Reumatología Mendoza
Mendoza, M5631AHF, Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, T4000AXL, Argentina
Southern Clinical Research
Hobart, 7000, Australia
Liverpool Hospital
Liverpool, 2170, Australia
Skin Health Institute Inc.
Melbourne, 3053, Australia
Eastern Health - Box Hill Hospital
Melbourne, 3128, Australia
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5804, Bulgaria
Medical Center Unimed Plovdiv
Plovdiv, 4001, Bulgaria
UMHAT Kaspela
Plovdiv, 4001, Bulgaria
Diagnosis-consulting centre-1
Rousse, 7002, Bulgaria
Military Medical Academy
Sofia, 1606, Bulgaria
UMHAT St. Ivan Rilski
Sofia, 1612, Bulgaria
ASIMP Rheumatology Centre St Irina EOOD
Sofia, 1750, Bulgaria
University Multiprofile Hospital Sofiamed Sofia
Sofia, 1770, Bulgaria
Medical Centre Synexus
Sofia, 1794, Bulgaria
RHEUMA s r o
Břeclav, 690 02, Czechia
L K N Arthrocentrum
Hlučín, 748 01, Czechia
MUDr Rosypalova s r o
Ostrava, 70800, Czechia
Arthrohelp S.R.O.
Pardubice, 53002, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Medical Plus S R O
Uherské Hradiště, 68601, Czechia
PV Medical S R O
Zlín, 76001, Czechia
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Uno Medical Trials Ltd.
Budapest, 1152, Hungary
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
Debrecen, 4031, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
Szeged, 6725, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár, H-8000, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, 8200, Hungary
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Hospital Selayang
Batu Caves, 68100, Malaysia
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Nzoz Bif Med
Bytom, 41 902, Poland
Centrum Kliniczno Badawcze
Elblag, 82-300, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30 002, Poland
Malopolskie Centrum Kliniczne
Krakow, 30 149, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Dermed Centrum Medyczne Sp z o o
Lodz, 90-265, Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, 90-338, Poland
NZOZ Lecznica MAK MED S C
Nadarzyn, 05-830, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Twoja Przychodnia PCM
Poznan, 60 324, Poland
Centrum Medyczne
Poznan, 61 113, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, 21 040, Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874, Poland
Rheuma Medicus Sp z o o
Warsaw, 02 118, Poland
Centrum Medyczne Reuma Park
Warsaw, 02 665, Poland
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, 51 685, Poland
GCM Medical Group
San Juan, 00917, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
FDI Clinical Research
San Juan, 00927, Puerto Rico
Altay Medical State University
Barnaul, 656038, Russia
Chelyabinck Regional Clinical Hospital
Chelyabinsk, 454076, Russia
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, 454092, Russia
Kemerovo State Medical University
Kemerovo, 650000, Russia
LLL Medical Center Revma-Med
Kemerovo, 650070, Russia
LLC Family Outpatient Clinic # 4
Korolyov, 141060, Russia
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar, 350020, Russia
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
Krasnoyarsk, 660123, Russia
Clinical-Diagnostic Center Euromedservice, JSC
Moscow, 115419, Russia
FGBU Research Institute of Rheumatology named V.A.Nasonova
Moscow, 115522, Russia
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
Moscow, 129110, Russia
GBOU VPO Orenburg State Medical University
Orenburg, 460000, Russia
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov-on-Don, 344007, Russia
St. Petersburg GBUZ Clinical Reumatological Hospital 25
Saint Petersburg, 190068, Russia
X7 Clinical Research Company Limited
Saint Petersburg, 194156, Russia
Saratov Regional Clinical Hospital
Saratov, 410053, Russia
Smolensk regional hospital on Smolensk railway station
Smolensk, 214025, Russia
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
Tolyatti, 445846, Russia
Tula Regional Clinical Dermatovenerological Dispensary
Tula, 300053, Russia
Republican Clinical Hospital - G.G. Kuvatov
Ufa, 450005, Russia
Hosp. Univ. de Cruces
Barakaldo, 48903, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Quiron Madrid Pozuelo
Madrid, 28223, Spain
Hosp Regional Univ de Malaga
Málaga, 29011, Spain
Clinica Gaias
Santiago de Compostela, 15702, Spain
Hosp. Quiron Sagrado Corazon
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Adana City Hospital
Adana, 01370, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 6100, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07070, Turkey (Türkiye)
Bursa Uludag Universitesi Hastanesi
Bursa, 16059, Turkey (Türkiye)
Pamukkale University Medical Faculty
Denizli, 20070, Turkey (Türkiye)
Osmangazi University Medical Faculty
Eskişehir, 26040, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Kartal Dr Lutfi Kirdar sehir Hastanesi
Istanbul, 34865, Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, 34899, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya, 42090, Turkey (Türkiye)
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61204, Ukraine
Khmelnitckiy regional hospital
Khmelnytsky, 29000, Ukraine
City Clinical Hospital No. 2
Kryvyi Rih, 50056, Ukraine
Medical Center LLC 'Harmony of Beauty'
Kyiv, 01135, Ukraine
Medical Center of 'Institute of Rheumatology', LLC
Kyiv, 02081, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, 02125, Ukraine
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv, 03049, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, 03151, Ukraine
Medical Center 'Consylium Medical'
Kyiv, 04050, Ukraine
Volyn Regional Clinical Hospital
Lutsk, 43005, Ukraine
LLC Medical House
Odesa, 65026, Ukraine
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
Poltava, 36011, Ukraine
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
Vinnytsia, 21018, Ukraine
Medical Center LLC 'Modern Clinic'
Zaporizhzhya, 69600, Ukraine
Related Publications (1)
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.
PMID: 38773563DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Leader PEDIATRICS IMM
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
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
June 16, 2021
First Posted
June 23, 2021
Study Start
September 28, 2021
Primary Completion
October 28, 2024
Study Completion (Estimated)
July 16, 2026
Last Updated
April 13, 2026
Results First Posted
December 8, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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