AzTrials
AzTrials

Arthritis, PsoriaticPhase 3SOLSTICENCT04936308

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

A Phase 3 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 169 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
453 participants
Where
169 sitesin 14 countries
Study dates
28 Sep 2021to 2 Jul 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

169 sites in 14 countries.

169 sites in 14 countries

United States50 sites

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102

  • Arizona Arthritis and Rheumatology Research PLLC 2

    Avondale, Arizona, 85392

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

  • Rheumatology and Pulmonary Clinic

    Beckley, West Virginia, 25801

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28211

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034

  • Adriana Pop Moody MD Clinic PA

    Corpus Christi, Texas, 78404

  • Metroplex Clinical Research Center

    Dallas, Texas, 75231

  • Clinical Research Center of Connecticut

    Danbury, Connecticut, 06810

  • Omega Research Consultants

    DeBary, Florida, 32713

  • St. Paul Rheumatology P A

    Eagan, Minnesota, 55121

  • Arizona Arthritis and Rheumatology Research PLLC 3

    Flagstaff, Arizona, 86001-6218

  • Precision Comprehensive Clinical Research Solutions 1

    Fort Worth, Texas, 76107

  • Klein And Associates M D P A

    Hagerstown, Maryland, 21740

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • Great Lakes Center of Rheumatology

    Lansing, Michigan, 48911

  • Arthritis and Osteoperosis Associates of New Mexico

    Las Cruces, New Mexico, 88011

  • West Texas Clinical Research

    Lubbock, Texas, 79424

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119

  • Arizona Arthritis and Rheumatology Research PLLC

    Mesa, Arizona, 85210

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

  • The Arthritis and Diabetes Clinic

    Monroe, Louisiana, 71203

  • Arthritis Associates

    Mountain Brook, Alabama, 35223

  • Advanced Clinical Research of Orlando

    Ocoee, Florida, 34761

  • Arthritis and Rheumatology Center of MI

    Okemos, Michigan, 48864

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma, 73103

  • Rheumatology Associates of Oklahoma

    Oklahoma City, Oklahoma, 73116

  • Buffalo Rheumatology and Medicine PLLC

    Orchard Park, New York, 14127

  • Arizona Arthritis and Rheumatology Research PLLC 1

    Phoenix, Arizona, 85032

  • Texas Rheumatology Care

    Plano, Texas, 75024

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324

  • Clinical Research Institute of Michigan, LLC

    Saint Clair Shores, Michigan, 48081

  • Unity Health-White County Medical Center

    Searcy, Arkansas, 72143

  • Clinic of Robert Hozman

    Skokie, Illinois, 60076

  • Arthritis Northwest PLLC 1

    Spokane, Washington, 99204

  • Arthritis Consultants

    St Louis, Missouri, 63141

  • Arizona Arthritis and Rheumatology Associates

    Sun City, Arizona, 85351

  • Clinical Research of West Florida 1

    Tampa, Florida, 33606

  • Advanced Rheumatology of Houston

    The Woodlands, Texas, 77382

  • Medvin Clinical Research 2

    Thousand Oaks, California, 91360

  • DM Clinical Research

    Tomball, Texas, 77375

  • Southern Arizona VA Healthcare System

    Tucson, Arizona, 85723

  • Medvin Clinical Research

    Tujunga, California, 91042

  • STAT Research, Inc.

    Vandalia, Ohio, 45377

  • Arthritis Rheumatic And Back Disease Associates

    Voorhees Township, New Jersey, 08043

  • Arthritis And Osteoporosis Clinic

    Waco, Texas, 76710

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Russia20 sites

  • Altay Medical State University

    Barnaul, 656038

  • Chelyabinck Regional Clinical Hospital

    Chelyabinsk, 454076

  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary

    Chelyabinsk, 454092

  • Kemerovo State Medical University

    Kemerovo, 650000

  • LLL Medical Center Revma-Med

    Kemerovo, 650070

  • LLC Family Outpatient Clinic # 4

    Korolyov, 141060

  • Krasnodar Clinical Dermatovenerologic Dispensary

    Krasnodar, 350020

  • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon

    Krasnoyarsk, 660123

  • Clinical-Diagnostic Center Euromedservice, JSC

    Moscow, 115419

  • FGBU Research Institute of Rheumatology named V.A.Nasonova

    Moscow, 115522

  • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'

    Moscow, 129110

  • GBOU VPO Orenburg State Medical University

    Orenburg, 460000

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov-on-Don, 344007

  • St. Petersburg GBUZ Clinical Reumatological Hospital 25

    Saint Petersburg, 190068

  • X7 Clinical Research Company Limited

    Saint Petersburg, 194156

  • Saratov Regional Clinical Hospital

    Saratov, 410053

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025

  • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'

    Tolyatti, 445846

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, 300053

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005

Other trials in Russia

Poland16 sites

  • Nzoz Bif Med

    Bytom, 41 902

  • Centrum Kliniczno Badawcze

    Elblag, 82-300

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30 002

  • Malopolskie Centrum Kliniczne

    Krakow, 30 149

  • Centrum Medyczne Promed

    Krakow, 31-513

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90-265

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05-830

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • Twoja Przychodnia PCM

    Poznan, 60 324

  • Centrum Medyczne

    Poznan, 61 113

  • Lubelskie Centrum Diagnostyczne

    Świdnik, 21 040

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-874

  • Rheuma Medicus Sp z o o

    Warsaw, 02 118

  • Centrum Medyczne Reuma Park

    Warsaw, 02 665

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685

Other trials in Poland

Ukraine15 sites

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61204

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000

  • City Clinical Hospital No. 2

    Kryvyi Rih, 50056

  • Medical Center LLC 'Harmony of Beauty'

    Kyiv, 01135

  • Medical Center of 'Institute of Rheumatology', LLC

    Kyiv, 02081

  • Kyiv City Clinical Hospital #3

    Kyiv, 02125

  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

    Kyiv, 03049

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 03151

  • Medical Center 'Consylium Medical'

    Kyiv, 04050

  • Volyn Regional Clinical Hospital

    Lutsk, 43005

  • LLC Medical House

    Odesa, 65026

  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

    Poltava, 36011

  • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

    Vinnytsia, 21018

  • Medical Center LLC 'Modern Clinic'

    Zaporizhzhya, 69600

Other trials in Ukraine

Turkey (Türkiye)14 sites

  • Adana City Hospital

    Adana, 01370

  • Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Hacettepe University Medical Faculty

    Ankara, 6100

  • Akdeniz Universitesi Hastanesi

    Antalya, 07070

  • Bursa Uludag Universitesi Hastanesi

    Bursa, 16059

  • Pamukkale University Medical Faculty

    Denizli, 20070

  • Osmangazi University Medical Faculty

    Eskişehir, 26040

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Kartal Dr Lutfi Kirdar sehir Hastanesi

    Istanbul, 34865

  • Marmara University Medical Faculty

    Istanbul, 34899

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi

    Konya, 42090

Other trials in Turkey (Türkiye)

Bulgaria9 sites

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5804

  • Medical Center Unimed Plovdiv

    Plovdiv, 4001

  • UMHAT Kaspela

    Plovdiv, 4001

  • Diagnosis-consulting centre-1

    Rousse, 7002

  • Military Medical Academy

    Sofia, 1606

  • UMHAT St. Ivan Rilski

    Sofia, 1612

  • ASIMP Rheumatology Centre St Irina EOOD

    Sofia, 1750

  • University Multiprofile Hospital Sofiamed Sofia

    Sofia, 1770

  • Medical Centre Synexus

    Sofia, 1794

Other trials in Bulgaria

Hungary8 sites

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Uno Medical Trials Ltd.

    Budapest, 1152

  • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház

    Debrecen, 4031

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ

    Szeged, 6725

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, H-8000

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200

Other trials in Hungary

Argentina7 sites

  • Cosultorios Reumatologógicos Pampa

    Buenos Aires, 1428

  • OMI

    Buenos Aires, C1015ABO

  • CIPREC

    Buenos Aires, C1061AAS

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417EYG

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOS

  • Instituto de Reumatología Mendoza

    Mendoza, M5631AHF

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Czechia7 sites

  • RHEUMA s r o

    Břeclav, 690 02

  • L K N Arthrocentrum

    Hlučín, 748 01

  • MUDr Rosypalova s r o

    Ostrava, 70800

  • Arthrohelp S.R.O.

    Pardubice, 53002

  • Revmatologicky ustav

    Prague, 128 50

  • Medical Plus S R O

    Uherské Hradiště, 68601

  • PV Medical S R O

    Zlín, 76001

Other trials in Czechia

Spain7 sites

  • Hosp. Univ. de Cruces

    Barakaldo, 48903

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Quiron Madrid Pozuelo

    Madrid, 28223

  • Hosp Regional Univ de Malaga

    Málaga, 29011

  • Clinica Gaias

    Santiago de Compostela, 15702

  • Hosp. Quiron Sagrado Corazon

    Seville, 41013

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

Other trials in Spain

Israel5 sites

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 34362

  • Meir Medical Center

    Kfar Saba, 4428164

  • Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Australia4 sites

  • Southern Clinical Research

    Hobart, 7000

  • Liverpool Hospital

    Liverpool, 2170

  • Skin Health Institute Inc.

    Melbourne, 3053

  • Eastern Health - Box Hill Hospital

    Melbourne, 3128

Other trials in Australia

Malaysia4 sites

  • Hospital Selayang

    Batu Caves, 68100

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450

  • Hospital Tuanku Jaafar

    Seremban, 70300

Other trials in Malaysia

Puerto Rico3 sites

  • GCM Medical Group

    San Juan, 00917

  • Mindful Medical Research

    San Juan, 00918

  • FDI Clinical Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

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

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.

Read the 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.

Being tested
Guselkumab, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called Tremfya, CNTO1959

    Participants will receive guselkumab as SC injection.

  • PlaceboDrug

    Participants will receive matching placebo as SC injection.

Study groups in NCT04936308
Study groupRoleWhat they receive
Group 1: Guselkumab and PlaceboExperimentalParticipants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Receives: Drug: Guselkumab; Drug: Placebo
Group 2: GuselkumabExperimentalParticipants will receive guselkumab SC.
Receives: Drug: Guselkumab
Group 3: Placebo Followed by GuselkumabExperimentalParticipants will receive placebo SC and will cross over to receive guselkumab SC.
Receives: Drug: Guselkumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 24

Secondary outcomes (20)

  1. 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).

    Measured: At Week 24

  2. 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.

    Measured: At Week 24

  3. 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.

    Measured: Baseline (pre dose Week 0) and Week 24

  4. 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.

    Measured: Baseline (pre dose Week 0) and Week 24

  5. 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.

    Measured: Baseline (pre dose Week 0) and Week 24

  6. 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).

    Measured: At Week 24

  7. 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.

    Measured: At Week 16

  8. 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.

    Measured: At Week 16

  9. 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.

    Measured: At Week 24

  10. 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.

    Measured: At Week 24

  11. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: From first administration of study drug (Week 0) up to Week 112

  12. Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

    Measured: From first administration of study drug (Week 0) up to Week 112

  13. Percentage of Participants With Treatment Emergent Related AEs (TERAEs)

    Measured: From first administration of study drug (Week 0) up to Week 112

  14. Treatment Emergent AEs Leading to Discontinuation of Study Intervention

    Measured: From first administration of study drug (Week 0) up to Week 112

  15. Percentage of Participants With Infections

    Measured: From first administration of study drug (Week 0) up to Week 112

  16. Percentage of Participants With Injection-site Reactions

    Measured: From first administration of study drug (Week 0) up to Week 112

  17. Percentage of Participants With Infusion Related Reactions

    Measured: From first administration of study drug (Week 0) up to Week 112

  18. 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)

    Measured: From first administration of study drug (Week 0) up to Week 112

  19. Serum Guselkumab Concentration Over Time

    Serum concentrations of guselkumab over time was reported.

    Measured: At Weeks 0, 4, 8, 12, 16, 20,and 24

  20. 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.

    Measured: Baseline (pre dose Week 0) up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start28 Sep 2021
  3. Primary completion28 Oct 2024
  4. Study completion2 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04936308
Sponsor's protocol ID
CR109039
Other IDs
CNTO1959PSA3005, 2021-000482-32, 2023-504715-33-00, 2023
Acronym
SOLSTICE
Status last verified
Jul 2026
First submitted
16 Jun 2021
Last updated
20 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Ogdie A, Merola JF, Mease PJ, Ritchlin CT, Scher JU, Lafferty KP, Chan D, Chakravarty SD, Langholff W, Wang Y, Shao J, Krol Y, Gottlieb AB. Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week-24 Results of a Phase 3, Randomized, Placebo-Controlled Study. Arthritis Rheumatol. 2026 Aug;78(8):1674-1686. doi: 10.1002/art.70092. Epub 2026 Apr 16.

    PubMed 41670439

  • 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.

    PubMed 38773563

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab in people with Arthritis, Psoriatic, run by Janssen Research & Development, LLC at 169 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Russia, Poland, Ukraine, Turkey (Türkiye) and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936308, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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