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

February 27, 2024 updated by: Janssen Research & Development, LLC

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

Recruiting

Intervention / Treatment

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 (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Buenos Aires, Argentina, C1417EYG
        • Recruiting
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Argentina, 1428
        • Recruiting
        • Cosultorios Reumatologógicos Pampa
      • Buenos Aires, Argentina, C1426BOS
        • Recruiting
        • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
      • Ciudad Autonoma de Buenos Aires, Argentina, C1061AAS
        • Recruiting
        • CIPREC
      • Ciudad Autónoma de Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • OMI
      • Ciudad de Mendoza, Argentina, M5631AHF
        • Recruiting
        • Instituto de Reumatología Mendoza
      • San Miguel De Tucuman, Argentina, T4000AXL
        • Recruiting
        • Centro de Investigaciones Médicas Tucuman
      • Hobart, Australia, 7000
        • Terminated
        • Southern Clinical Research
      • Liverpool, Australia, 2170
        • Terminated
        • Liverpool Hospital
      • Melbourne, Australia, 3053
        • Terminated
        • Skin Health Institute Inc.
      • Melbourne, Australia, 3128
        • Terminated
        • Eastern Health - Box Hill Hospital
      • Pleven, Bulgaria, 5804
        • Recruiting
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • Medical Center Unimed Plovdiv
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • UMHAT Kaspela
      • Ruse, Bulgaria, 7002
        • Recruiting
        • Diagnosis-consulting centre-1
      • Sfia, Bulgaria, 1612
        • Recruiting
        • UMHAT St. Ivan Rilski
      • Sofia, Bulgaria, 1794
        • Completed
        • Medical Centre Synexus
      • Sofia, Bulgaria, 1606
        • Completed
        • Military Medical Academy
      • Sofia, Bulgaria, 1770
        • Completed
        • University Multiprofile Hospital Sofiamed Sofia
      • Sofia, Bulgaria, 1750
        • Recruiting
        • ASIMP Rheumatology Centre St Irina EOOD
      • Breclav, Czechia, 691 02
        • Recruiting
        • Rheuma s.r.o.
      • Hlucin, Czechia, 748 01
        • Recruiting
        • L.K.N Arthrocentrum
      • Ostrava, Czechia, 70800
        • Recruiting
        • MUDr. Rosypalova, s.r.o
      • Pardubice, Czechia, 53002
        • Recruiting
        • ARTHROHELP s.r.o.
      • Praha 2, Czechia, 128 50
        • Recruiting
        • Revmatologicky ustav
      • Uherske Hradiste, Czechia, 68601
        • Recruiting
        • Medical Plus S.R.O.
      • Zlin, Czechia, 76001
        • Completed
        • PV-Medical S.R.O
      • Budapest, Hungary, 1023
        • Recruiting
        • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
      • Budapest, Hungary, 1152
        • Recruiting
        • Uno Medical Trials Ltd.
      • Debrecen, Hungary, 4031
        • Completed
        • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
      • Gyula, Hungary, 5700
        • Recruiting
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
      • Kistarcsa, Hungary, 2143
        • Recruiting
        • Pest Megyei Flor Ferenc Korhaz
      • Szeged, Hungary, 6725
        • Recruiting
        • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
      • Szekesfehervar, Hungary, H-8000
        • Recruiting
        • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
      • Veszprem, Hungary, 8200
        • Recruiting
        • Vital Medical Center Orvosi es Fogaszati Kozpont
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Recruiting
        • Bnai Zion Medical Center
      • Hifa, Israel, 34362
        • Recruiting
        • Carmel Medical Center
      • Kfar-Sava, Israel, 4428164
        • Completed
        • Meir Medical Center
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
      • Batu Caves, Malaysia, 68100
        • Completed
        • Hospital Selayang
      • George Town, Malaysia, 10990
        • Completed
        • Hospital Pulau Pinang
      • Ipoh, Malaysia, 30450
        • Recruiting
        • Hospital Raja Permaisuri Bainun
      • Seremban, Malaysia, 70300
        • Completed
        • Hospital Tuanku Jaafar
      • Bytom, Poland, 41-902
        • Recruiting
        • Nzoz Bif-Med
      • Elblag, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno Badawcze
      • Krakow, Poland, 30-149
        • Recruiting
        • Malopolskie Centrum Kliniczne
      • Krakow, Poland, 31-513
        • Recruiting
        • Centrum Medyczne PROMED
      • Krakow, Poland, 30-002
        • Recruiting
        • Malopolskie Badania Kliniczne Sp. z o.o.
      • Lodz, Poland, 90-338
        • Recruiting
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
      • Lodz, Poland, 90-265
        • Recruiting
        • Dermed Centrum Medyczne Sp z o o
      • Nadarzyn, Poland, 05-830
        • Recruiting
        • NZOZ Lecznica MAK-MED. S.C.
      • Nowa Sol, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia - Centrum Medyczne Nowa Sol
      • Poznan, Poland, 61-113
        • Recruiting
        • Centrum Medyczne
      • Poznan, Poland, 61-293
        • Recruiting
        • Twoja Przychodnia
      • Swidnik, Poland, 21-040
        • Completed
        • Lubelskie Centrum Diagnostyczne
      • Warsaw, Poland, 00-874
        • Recruiting
        • MICS Centrum Medyczne Warszawa
      • Warszawa, Poland, 02-118
        • Recruiting
        • Rheuma-Medicus, Zaklad Opieki Zdrowotnej
      • Warszawa, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
      • Wrocław, Poland, 51-685
        • Recruiting
        • WroMedica I.Bielicka, A.Strzałkowska s.c.
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • GCM Medical Group
      • San Juan, Puerto Rico, 00918
        • Recruiting
        • Mindful Medical Research
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
      • Barnaul, Russian Federation, 656038
        • Suspended
        • Altay Medical State University
      • Chelyabinsk, Russian Federation, 454076
        • Terminated
        • Chelyabinck Regional Clinical Hospital
      • Chelyabinsk, Russian Federation, 454092
        • Suspended
        • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
      • Kemerovo, Russian Federation, 650000
        • Suspended
        • Kemerovo State Medical University
      • Kemerovo, Russian Federation, 650070
        • Suspended
        • LLL Medical Center Revma-Med
      • Korolev, Russian Federation, 141060
        • Suspended
        • LLC Family Outpatient Clinic # 4
      • Krasnodar, Russian Federation, 350020
        • Suspended
        • Krasnodar Clinical Dermatovenerologic Dispensary
      • Krasnoyarsk, Russian Federation, 660123
        • Terminated
        • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
      • Moscow, Russian Federation, 115419
        • Terminated
        • Clinical-Diagnostic Center Euromedservice, JSC
      • Moscow, Russian Federation, 115522
        • Terminated
        • FGBU Research Institute of Rheumatology named V.A.Nasonova
      • Moscow, Russian Federation, 129110
        • Suspended
        • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
      • Orenburg, Russian Federation, 460000
        • Terminated
        • GBOU VPO Orenburg State Medical University
      • Rostov, Russian Federation, 344007
        • Suspended
        • Rostov Regional Clinical Dermatovenerological Dispensary
      • Saratov, Russian Federation, 410053
        • Terminated
        • Saratov regional clinical hospital
      • Smolensk, Russian Federation, 214025
        • Terminated
        • Smolensk regional hospital on Smolensk railway station
      • St. Petersburg, Russian Federation, 190068
        • Terminated
        • St. Petersburg GBUZ Clinical Reumatological Hospital 25
      • St. Petersburg, Russian Federation, 194156
        • Terminated
        • X7 Clinical Research Company Limited
      • Tolyatti, Russian Federation, 445846
        • Terminated
        • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
      • Tula, Russian Federation, 300053
        • Terminated
        • Tula Regional Clinical Dermatovenerological Dispensary
      • Ufa, Russian Federation, 450005
        • Suspended
        • Republican Clinical Hospital - G.G. Kuvatov
      • Barakaldo, Spain, 48903
        • Recruiting
        • Hosp. Univ. de Cruces
      • Madrid, Spain, 28006
        • Recruiting
        • Hosp. Univ. de La Princesa
      • Madrid, Spain, 28223
        • Recruiting
        • Hosp. Quiron Madrid Pozuelo
      • Málaga, Spain, 29011
        • Recruiting
        • Hosp. Regional Univ. de Malaga
      • Santiago de Compostela, Spain, 15702
        • Recruiting
        • Clinica Gaias
      • Sevilla, Spain, 41013
        • Recruiting
        • Hosp. Quiron Sagrado Corazon
      • Valencia, Spain, 46010
        • Recruiting
        • Hosp. Clinico Univ. de Valencia
      • Adana, Turkey, 01370
        • Recruiting
        • Adana City Hospital
      • Ankara, Turkey, 06010
        • Recruiting
        • Gulhane Training and Research Hospital
      • Ankara, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital
      • Ankara, Turkey, 6100
        • Recruiting
        • Hacettepe University Medical Faculty
      • Antalya, Turkey, 7059
        • Recruiting
        • Akdeniz University Medical Faculty
      • Bursa, Turkey, 16059
        • Recruiting
        • Uludag University Medical Faculty
      • Denizli, Turkey, 20070
        • Recruiting
        • Pamukkale University Medical Faculty
      • Eskisehir, Turkey, 26040
        • Recruiting
        • Osmangazi University Medical Faculty
      • Istanbul, Turkey, 34098
        • Completed
        • Istanbul University Cerrahpasa Medical Faculty
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University Medical Faculty
      • Istanbul, Turkey, 34865
        • Recruiting
        • Kartal Dr Lutfi Kirdar Sehir Hastanesi
      • Istanbul, Turkey, 34093
        • Completed
        • Istanbul University Istanbul Medical Faculty
      • Kocaeli, Turkey, 41380
        • Completed
        • Kocaeli University Medical Faculty
      • Konya, Turkey, 42080
        • Recruiting
        • Necmettin Erbakan University Meram Medical Faculty
      • Cherkasy, Ukraine, 18009
        • Terminated
        • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
      • Kharkiv, Ukraine, 61204
        • Suspended
        • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
      • Khmelnytsky, Ukraine, 29000
        • Completed
        • Khmelnitckiy regional hospital
      • Kryvyi Rih, Ukraine, 50056
        • Terminated
        • City Clinical Hospital No. 2
      • Kyiv, Ukraine, 01135
        • Terminated
        • Medical Center LLC 'Harmony of Beauty'
      • Kyiv, Ukraine, 02081
        • Suspended
        • Medical Center of 'Institute of Rheumatology', LLC
      • Kyiv, Ukraine, 02125
        • Suspended
        • Kyiv City Clinical Hospital #3
      • Kyiv, Ukraine, 03049
        • Suspended
        • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
      • Kyiv, Ukraine, 04050
        • Suspended
        • Medical Center 'Consylium Medical'
      • Kyiv, Ukraine, 03151
        • Suspended
        • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
      • Lutsk, Ukraine, 43005
        • Suspended
        • Volyn Regional Clinical Hospital
      • Odessa, Ukraine, 65026
        • Terminated
        • LLC Medical House
      • Poltava, Ukraine, 36011
        • Suspended
        • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
      • Vinnytsya, Ukraine, 21018
        • Terminated
        • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
      • Zaporizhzhya, Ukraine, 69600
        • Suspended
        • Medical Center LLC 'Modern Clinic'
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Completed
        • Rheumatology Associates
    • Arizona
      • Flagstaff, Arizona, United States, 86001-6218
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Mesa, Arizona, United States, 85210
        • Completed
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Phoenix, Arizona, United States, 85037
        • Recruiting
        • Arizona Arthritis and Rheumatology Research PLLC
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Healthcare System
    • Arkansas
      • Searcy, Arkansas, United States, 72143
        • Recruiting
        • Unity Health-White County Medical Center
    • California
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Newport Huntington Medical Group
      • Thousand Oaks, California, United States, 91360
        • Completed
        • Medvin Clinical Research
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Completed
        • Clinical Research Center of Connecticut
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA Healthcare System
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Clinical Research of West Florida
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Omega Research Consultants
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Advanced Clinical Research of Orlando
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Integral Rheumatology & Immunology Specialists
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Clinical Research of West Florida
      • Zephyrhills, Florida, United States, 33542
        • Recruiting
        • Florida Medical Clinic, P.A.
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Completed
        • Great Lakes Clinical Trials
      • Skokie, Illinois, United States, 60076
        • Recruiting
        • Clinic of Robert Hozman
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • Recruiting
        • The Arthritis and Diabetes Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Johns Hopkins University
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Klein And Associates M D P A
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Recruiting
        • Great Lakes Center of Rheumatology
      • Okemos, Michigan, United States, 48864
        • Recruiting
        • Arthritis and Rheumatology Center of MI
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan, LLC
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Recruiting
        • St. Paul Rhuematology P A
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Completed
        • Arthritis Consultants
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Recruiting
        • Arthritis Rheumatic And Back Disease Associates
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Albuquerque Center for Rheumatology
      • Las Cruces, New Mexico, United States, 88011
        • Completed
        • Arthritis and Osteoperosis Associates of New Mexico
    • New York
      • Orchard Park, New York, United States, 14127
        • Recruiting
        • Buffalo Rheumatology and Medicine PLLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • DJL Clinical Research, PLLC
    • Ohio
      • Vandalia, Ohio, United States, 45377
        • Completed
        • STAT Research, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Completed
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Recruiting
        • Rheumatology Associates of Oklahoma
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Dr. Ramesh Gupta
    • Texas
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions
      • Corpus Christi, Texas, United States, 78404
        • Recruiting
        • Adriana Pop Moody MD Clinic PA
      • Dallas, Texas, United States, 75231
        • Completed
        • Metroplex Clinical Research Center
      • Fort Worth, Texas, United States, 76107
        • Completed
        • Precision Comprehensive Clinical Research Solutions
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • West Texas Clinical Research
      • Mesquite, Texas, United States, 75150
        • Completed
        • Southwest Rheumatology Research LLC
      • Plano, Texas, United States, 75024
        • Recruiting
        • Texas Rheumatology Care
      • The Woodlands, Texas, United States, 77382
        • Recruiting
        • Advanced Rheumatology of Houston
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research
      • Waco, Texas, United States, 76710
        • Recruiting
        • Arthritis & Osteoporosis Clinic
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Arthritis Northwest PLLC
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Recruiting
        • Rheumatology & Pulmonary Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Participants will receive matching placebo as SC injection.
Participants will receive guselkumab as SC injection.
Other Names:
  • Tremfya
  • CNTO1959
Experimental: Group 2: Guselkumab
Participants will receive guselkumab SC.
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.
Participants will receive matching placebo as SC injection.
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 Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Week 24
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
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
Time Frame: Week 24
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
Change From Baseline in HAQ-DI Score at Week 24
Time Frame: Baseline and 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
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Time Frame: Baseline and 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
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
Time Frame: Baseline and 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
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Time Frame: 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
Percentage of Participants who Achieve ACR 20 Response at Week 16
Time Frame: 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
Percentage of Participants who Achieve ACR 50 Response at Week 16
Time Frame: 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
Percentage of Participants who Achieve ACR 50 Response at Week 24
Time Frame: 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
Percentage of Participants who Achieve ACR 70 Response at Week 24
Time Frame: 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
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Time Frame: Up to 112 weeks
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
Percentage of Participants With AEs leading to Discontinuation of Study Intervention
Time Frame: Up to 112 weeks
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Up to 112 weeks
Percentage of Participants With Infections
Time Frame: Up to 112 weeks
Percentage of participants with infections will be reported.
Up to 112 weeks
Percentage of Participants With Injection-site Reactions
Time Frame: Up to 100 weeks
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
Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Time Frame: Up to 112 weeks
Percentage of participants with change from baseline in clinical laboratory abnormalities including chemistry and hematology will be reported.
Up to 112 weeks
Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity
Time Frame: Up to 112 weeks
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
Serum Guselkumab Concentration
Time Frame: Up to 112 weeks
Serum guselkumab concentration will be measured.
Up to 112 weeks
Percentage of Participants With Anti-guselkumab Antibodies
Time Frame: Up to 112 weeks
Percentage of participants with anti-guselkumab antibodies to guselkumab will be reported.
Up to 112 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Estimated)

December 24, 2025

Study Completion (Estimated)

September 7, 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 (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CR109039
  • 2021-000482-32 (EudraCT Number)
  • CNTO1959PSA3005 (Other Identifier: Janssen Research & Development, LLC)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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