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A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (STAR)

Primary Purpose

Arthritis, Psoriatic

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening
  • Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
  • Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints)
  • Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4
  • Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis

Exclusion Criteria:

  • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
  • Has previously received any biologic treatment
  • Has ever received a 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

Sites / Locations

  • Arizona Arthritis & Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis Research, PLC.Recruiting
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis & Rheumatology AssociatesRecruiting
  • Southern Arizona VA Healthcare SystemRecruiting
  • Unity Health-White County Medical CenterRecruiting
  • Newport Huntington Medical GroupRecruiting
  • Clinical Research Center of Connecticut
  • Bay Pines VA Healthcare SystemRecruiting
  • Integral Rheumatology & Immunology SpecialistsRecruiting
  • Florida Medical Clinic, P.A.
  • Great Lakes Clinical TrialsRecruiting
  • RC ResearchRecruiting
  • OrthoIllinoisRecruiting
  • Klein & Associates, M.D., P.A.
  • Clinical Research Institute of Michigan, LLCRecruiting
  • St. Paul Rhuematology, P.A.Recruiting
  • ClinvestRecruiting
  • STAT Research, Inc.
  • OHSU Rheumatology Clinic, Marquam HillRecruiting
  • Amarillo Center for Clinical ResearchRecruiting
  • Austin Regional Clinic
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Adriana Pop Moody MD Clinic PA
  • UT Physicians Center for AutoimmunityRecruiting
  • West Texas Clinical ResearchRecruiting
  • Southwest Rheumatology Research LLC
  • Epic Medical ResearchRecruiting
  • DM Clinical ResearchRecruiting
  • Swedish Medical CenterRecruiting
  • Cosultorios Reumatologógicos PampaRecruiting
  • Hospital Italiano de Buenos AiresRecruiting
  • Centro Privado de Medicina FamiliarRecruiting
  • Hospital Italiano La PlataRecruiting
  • Emeritus Research
  • Southern Clinical ResearchRecruiting
  • Liverpool Hospital
  • Rheumatology Research Unit
  • Skin Health Institute Inc.
  • Eastern Health - Box Hill Hospital
  • Exacta MedicaRecruiting
  • UMHAT 'Dr. Georgi Stranski', EADRecruiting
  • Medical Center Unimed PlovdivRecruiting
  • UMHAT KaspelaRecruiting
  • UMHAT St. Ivan RilskiRecruiting
  • MHAT 'Lyulin' EADRecruiting
  • University Multiprofile Hospital Sofiamed Sofia
  • Military Medical AcademyRecruiting
  • ASIMP Rheumatology Centre "St Irina" EOODRecruiting
  • Medical Centre SynexusRecruiting
  • DDC Sv. Ivan Rilski OODRecruiting
  • Skin Care CentreRecruiting
  • Eastern Regional Health Authority, St. Clare's Mercy HospitalRecruiting
  • Toronto Western HospitalRecruiting
  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.Recruiting
  • Revmacentrum MUDr. Mostera, s.r.o.Recruiting
  • RevmaclinicRecruiting
  • Revmatologie s.r.o.Recruiting
  • L.K.N ArthrocentrumRecruiting
  • MUDr. Rosypalova, s.r.oRecruiting
  • Arthrohelp S.R.O.Recruiting
  • Revmatologicky ustavRecruiting
  • Medical Plus S.R.O.Recruiting
  • Frederiksberg HospitalRecruiting
  • Rigshospitalet GlostrupRecruiting
  • Køge Sygehus Region SjaellandRecruiting
  • Vejle SygehusRecruiting
  • LTD Clinic LJRecruiting
  • Ltd New HospitalsRecruiting
  • Consilium Medulla-multiprofile clinic LtdRecruiting
  • ISA - Interdisciplinary Study Association GmbHRecruiting
  • Hamburger Rheuma Forschungszentrum II
  • Rheumazentrum RuhrgebietRecruiting
  • Rheumazentrum RatingenRecruiting
  • Prince Of Wales HospitalRecruiting
  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi KorhazRecruiting
  • Qualiclinic KftRecruiting
  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
  • Pest Megyei Flor Ferenc KorhazRecruiting
  • Fejer Varmegyei Szent Gyorgy Egyetemi OktatokorhazRecruiting
  • Vital Medical Center Orvosi es Fogaszati KozpontRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Meir Medical Center
  • Sheba Medical CenterRecruiting
  • A.O. Universitaria Ospedali Riuniti di AnconaRecruiting
  • Azienda Ospedaliero-Universitaria di CagliariRecruiting
  • Arcispedale Santa Maria Nuova - IRCCSRecruiting
  • Policlinico Tor VergataRecruiting
  • Humanitas HospitalRecruiting
  • Hospital SelayangRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Sultan IsmailRecruiting
  • University Malaya Medical CentreRecruiting
  • Hospital Tuanku JaafarRecruiting
  • ClinicMed Daniluk, Nowak Spolka KomandytowaRecruiting
  • Szpital Uniwersytecki nr 2 im. Jana Biziela w BydgoszczyRecruiting
  • Nzoz Bif-MedRecruiting
  • Ambulatorium sp. z o.o.Recruiting
  • Centrum Kliniczno BadawczeRecruiting
  • Malopolskie Badania Kliniczne Sp. z o.o.Recruiting
  • Centrum Medyczne PromedRecruiting
  • Dermed Centrum Medyczne Sp. z o.oRecruiting
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-AkcyjnaRecruiting
  • Centrum Medyczne AMED oddzial w LodziRecruiting
  • Pro Life Medica Sp. z o.o.Recruiting
  • NZOZ Lecznica MAK-MED. S.C.Recruiting
  • Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
  • Centrum Badan KlinicznychRecruiting
  • Twoja Przychodnia Poznanskie Centrum MedyczneRecruiting
  • Lubelskie Centrum DiagnostyczneRecruiting
  • MICS Centrum Medyczne TorunRecruiting
  • MICS Centrum Medyczne WarszawaRecruiting
  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory ReicherRecruiting
  • Rheuma-Medicus Sp. z o.o.Recruiting
  • Centrum Medyczne Reuma ParkRecruiting
  • ETG WarszawaRecruiting
  • Centrum Medyczne AMED TargowekRecruiting
  • WroMedica I.Bielicka, A.Strzałkowska s.c.Recruiting
  • Ccab - Hosp. de BragaRecruiting
  • Ulsg - Hosp. Sousa MartinsRecruiting
  • Ipr - Inst. Port. de ReumatologiaRecruiting
  • Chlo - Hosp. Egas MonizRecruiting
  • Hospital CUF Tejo
  • Chln - Hosp. Santa MariaRecruiting
  • Ulsam - Hosp. Conde de BertiandosRecruiting
  • Chsj - Hosp. Sao JoaoRecruiting
  • Altay Medical State University
  • Chelyabinck Regional Clinical Hospital
  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
  • Sverdlovsk Regional Clinical Hospital N. 1
  • Regional Clinical Diagnostic Center of Udmurtia Region
  • LLL Medical Center Revma-Med
  • LLC Family Outpatient Clinic # 4
  • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
  • Clinical-Diagnostic Center Euromedservice, JSC
  • FGBU Research Institute of Rheumatology named V.A.Nasonova
  • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
  • Llc Ultramed
  • GBOU VPO Orenburg State Medical University
  • GBUZ Perm Regional Clinical Hospital
  • Republican Hospital n.a.V.A.Baranov
  • Rostov Regional Clinical Dermatovenerological Dispensary
  • St. Petersburg GBUZ Clinical Reumatological Hospital 25
  • X7 Clinical Research Company Limited
  • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
  • Republican Clinical Hospital - G.G. Kuvatov
  • Clinical Hospital #3
  • Reumatologicka ambulanciaRecruiting
  • Reumatologická ambulancia Thermium s.r.o.Recruiting
  • Reumex s.r.oRecruiting
  • Hosp. Univ. A CoruñaRecruiting
  • Hosp. Univ. de CrucesRecruiting
  • Hosp. Clinic I Provincial de BarcelonaRecruiting
  • Hosp. Univ. de BasurtoRecruiting
  • Hosp. Reina SofiaRecruiting
  • Hosp. Clinico San Carlos
  • Hosp. Regional Univ. de MalagaRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Clinica GaiasRecruiting
  • Hosp. Virgen MacarenaRecruiting
  • Hosp. Quiron Sagrado CorazonRecruiting
  • Hosp. Univ. I Politecni La FeRecruiting
  • Karolinska UniversitetssjukhusetRecruiting
  • National Taiwan University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Linkou Chang Gung Memorial HospitalRecruiting
  • Phramongkutklao Hospital and Medical CollegeRecruiting
  • Ramathibodi Hospital, Mahidol UniversityRecruiting
  • Chiang Mai UniversityRecruiting
  • Adana City HospitalRecruiting
  • Gulhane Training and Research HospitalRecruiting
  • Ankara Bilkent City Hospital
  • Hacettepe University Medical Faculty
  • Akdeniz University Medical FacultyRecruiting
  • Uludag University Medical FacultyRecruiting
  • Istanbul University Cerrahpasa Medical FacultyRecruiting
  • Marmara University Medical FacultyRecruiting
  • Necmettin Erbakan University Meram Medical FacultyRecruiting
  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Khmelnitckiy regional hospital
  • City Clinical Hospital No. 2
  • Medical Center of 'Institute of Rheumatology', LLC
  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Volyn Regional Clinical Hospital
  • Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
  • Health Clinic Limited Liability Company
  • Medical Center LLC 'Modern Clinic'
  • Royal Free London NHS Foundation TrustRecruiting
  • St. Lukes HospitalRecruiting
  • Chapel Allerton HospitalRecruiting
  • North Tyneside General HospitalRecruiting
  • Haywood HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: Guselkumab and Placebo

Group 2: Guselkumab

Group 3: Placebo followed by Guselkumab

Arm Description

Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.

Participants will receive guselkumab SC.

Participants will receive matching placebo and will cross over to receive guselkumab SC.

Outcomes

Primary Outcome Measures

Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.

Secondary Outcome Measures

Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were 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.
Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Percentage of participants with IGA 0/1 response at week 24 among the participants with >= 3 percent (%) BSA psoriatic involvement and an IGA score of >= 2 (mild) at baseline will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given timepoint. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. 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).
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.
Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.
Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.
Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
Percentage of participants who achieve ASAS 40 response at Week 24 will be reported. ASAS 40 defined as improvement from baseline of >= 40% and with an absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Participant's global assessment (0 to 10 cm; 0=very well, 10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); no worsening at all from baseline in remaining domain.
Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.
Change from Baseline in SPARCC Score for MRI Spine at Week 24
Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.
Number of Participants with Adverse Events (AEs)
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.
Number of Participants with Serious Adverse Events (SAEs)
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Number of Participants with Reasonably Related AEs
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.
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Number of Participants with Infections
Number of participants with infections will be reported.
Number of participants with Injection-Site Reactions
Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.
Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
Number of participants with laboratory abnormalities (chemistry, hematology) by maximum toxicity (CTCAE 5.0) grades 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.
Serum Guselkumab Concentration Over Time
Serum guselkumab concentration over time will be reported.
Number of Participants with Antibodies to Guselkumab
Number of participants with antibodies to guselkumab will be reported.

Full Information

First Posted
June 11, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04929210
Brief Title
A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Acronym
STAR
Official Title
A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
February 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) axial disease by assessing reduction in axial symptoms and inflammation.
Detailed Description
PsA is a chronic inflammatory musculoskeletal disease that has 6 disease domains, and axial disease represents one of the domains. Guselkumab is a fully human immunoglobulin (Ig) G1 lambda monoclonal antibody (mAb) that by binding to the p19 protein subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine production. This study will consist of a screening phase (up to 6 weeks), a treatment phase (up to 48 weeks, including a placebo-controlled period from Week 0 to Week 24 and an active-controlled treatment phase from Week 24 to Week 48), and a safety follow-up phase (up to Week 60). The efficacy assessments will include assessment such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the safety assessments will include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events. The overall duration of the study will be up to 14 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab and Placebo
Arm Type
Experimental
Arm Description
Participants will receive guselkumab and matching placebo subcutaneously (SC) to maintain the blind.
Arm Title
Group 2: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab SC.
Arm Title
Group 3: Placebo followed by Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive matching placebo and will cross over to receive guselkumab SC.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
TREMFYA
Intervention Description
Guselkumab will be administered as subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered as subcutaneous injection.
Primary Outcome Measure Information:
Title
Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 24
Description
BASDAI is a self-assessment tool that consists of 6 questions relating to 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. First 5 items were scored on a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 equals to (=) none to 10=very severe. Quantitative morning stiffness was scored on a 10 cm VAS ranging from 0=0 hours to 10=2 or more hours. 2 scores for qualitative and quantitative morning stiffness were averaged, and total BASDAI score was average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) at Week 24
Description
The ASDAS-CRP is a composite of 5 disease activity variables with only partial overlap. The 4 self-reported items included in this index are back pain (VAS), duration of morning stiffness, peripheral pain/swelling, and participant global assessment of disease activity; these are combined with the C-reactive protein (CRP) value. Selected cut-offs for improvement scores are: a change greater than or equal to (>=) 1.1 units for "clinically important improvement" and a change >= 2.0 units for "major improvement.
Time Frame
Baseline and Week 24
Title
Change from Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) at Week 24
Description
DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (milligram/deciliter [mg/dL], value less than [<] lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), participant assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.
Time Frame
Baseline and Week 24
Title
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24
Description
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 were 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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants with Investigator's Global Assessment (IGA) 0/1 Response at Week 24 among Participants with >= 3% Body Surface Area (BSA) Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description
Percentage of participants with IGA 0/1 response at week 24 among the participants with >= 3 percent (%) BSA psoriatic involvement and an IGA score of >= 2 (mild) at baseline will be reported. The IGA documents the investigator's assessment of the participants psoriasis at a given timepoint. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. 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).
Time Frame
Week 24
Title
Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints at Week 24
Description
Change from baseline in SPARCC score for MRI SI joints at week 24 among the participants with a positive MRI of the sacroiliac joints at baseline will be reported. SPARCC method focuses on the cartilaginous portion of the SI joint, and scores presence (score of 1) versus absence (score of 0) of bone marrow edema in each SI joint quadrant.
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Achieve a >= 50 % Improvement from Baseline in BASDAI Score at Week 24
Description
Percentage of participants who achieve a >= 50 % improvement from baseline in BASDAI score at week 24 will be reported.
Time Frame
Baseline and Week 24
Title
Percentage of Participants who Achieve ASDAS Clinically Important Improvement at Week 24
Description
Percentage of participants who achieve ASDAS clinically important improvement at week 24 will be reported.
Time Frame
Week 24
Title
Percentage of Participants who Achieve Ankylosing Spondylitis Activity Score (ASAS) 40 Response at Week 24
Description
Percentage of participants who achieve ASAS 40 response at Week 24 will be reported. ASAS 40 defined as improvement from baseline of >= 40% and with an absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Participant's global assessment (0 to 10 cm; 0=very well, 10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none, 10=very severe); no worsening at all from baseline in remaining domain.
Time Frame
Week 24
Title
Percentage of Participants who Achieve ASDAS Major Improvement at Week 24
Description
Percentage of participants who achieve ASDAS major improvement at Week 24 will be reported.
Time Frame
Week 24
Title
Change from Baseline in SPARCC Score for MRI Spine at Week 24
Description
Change from baseline in SPARCC score for MRI spine at week 24 among the participants with a positive MRI of the spine at baseline will be reported. The SPARCC scoring system for the spine scores the 6 discovertebral units considered by the reader as the most abnormal, and then separately assesses each quadrant of 3 adjacent sagittal slices, with additional points for "depth" and high "intensity" of the lesion.
Time Frame
Baseline and Week 24
Title
Number of Participants with Adverse Events (AEs)
Description
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.
Time Frame
Up to 60 weeks
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time Frame
Up to 60 weeks
Title
Number of Participants with Reasonably Related AEs
Description
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.
Time Frame
Up to 60 weeks
Title
Number of Participants with AEs Leading to Discontinuation of Study Intervention
Description
Number of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 60 weeks
Title
Number of Participants with Infections
Description
Number of participants with infections will be reported.
Time Frame
Up to 60 weeks
Title
Number of participants with Injection-Site Reactions
Description
Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.
Time Frame
Up to 60 weeks
Title
Number of Participants with Laboratory Abnormalities (Chemistry, Hematology) by Maximum Toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) Grades
Description
Number of participants with laboratory abnormalities (chemistry, hematology) by maximum toxicity (CTCAE 5.0) grades 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.
Time Frame
Up to 60 weeks
Title
Serum Guselkumab Concentration Over Time
Description
Serum guselkumab concentration over time will be reported.
Time Frame
Up to 60 weeks
Title
Number of Participants with Antibodies to Guselkumab
Description
Number of participants with antibodies to guselkumab will be reported.
Time Frame
Up to 60 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) criteria at screening Have active PsA as defined by: a) at least 3 swollen joints and at least 3 tender joints at screening and at baseline and b) C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram/deciliter (mg/dL) at screening from the central laboratory, and despite previous non-biologic disease modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy Have magnetic resonance imaging (MRI)-confirmed PsA axial disease (positive MRI spine and/or sacroiliac [SI] joints, shown by a Spondyloarthritis Research Consortium of Canada [SPARCC] score of >= 3 in either the spine or the sacroiliac joints) Have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, and have a spinal pain score (on a visual analog scale [VAS]) of at least 4 Have active plaque psoriasis, with at least 1 psoriatic plaque of >= 2 centimeter (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis Exclusion Criteria: Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS)/non-radiographic-axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease Has previously received any biologic treatment Has ever received a 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis Research, PLC.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Arizona VA Healthcare System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Name
Unity Health-White County Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Individual Site Status
Recruiting
Facility Name
Newport Huntington Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Center of Connecticut
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Completed
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Recruiting
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Individual Site Status
Completed
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Name
RC Research
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Name
OrthoIllinois
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Individual Site Status
Recruiting
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Research Institute of Michigan, LLC
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Paul Rhuematology, P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
STAT Research, Inc.
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Individual Site Status
Completed
Facility Name
OHSU Rheumatology Clinic, Marquam Hill
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Completed
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Adriana Pop Moody MD Clinic PA
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Completed
Facility Name
UT Physicians Center for Autoimmunity
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
West Texas Clinical Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Completed
Facility Name
Epic Medical Research
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Name
Cosultorios Reumatologógicos Pampa
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Privado de Medicina Familiar
City
Buenos Aires
ZIP/Postal Code
C1417
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano La Plata
City
La Plata
ZIP/Postal Code
B1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Emeritus Research
City
Camberwell
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Completed
Facility Name
Southern Clinical Research
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Completed
Facility Name
Rheumatology Research Unit
City
Maroochydore
ZIP/Postal Code
4558
Country
Australia
Individual Site Status
Terminated
Facility Name
Skin Health Institute Inc.
City
Melbourne
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Terminated
Facility Name
Eastern Health - Box Hill Hospital
City
Melbourne
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Completed
Facility Name
Exacta Medica
City
Pleven
ZIP/Postal Code
5803
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Unimed Plovdiv
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT St. Ivan Rilski
City
Sfia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT 'Lyulin' EAD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital Sofiamed Sofia
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
ASIMP Rheumatology Centre "St Irina" EOOD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Centre Synexus
City
Sofia
ZIP/Postal Code
1794
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
DDC Sv. Ivan Rilski OOD
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Skin Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Eastern Regional Health Authority, St. Clare's Mercy Hospital
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Recruiting
Facility Name
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Revmacentrum MUDr. Mostera, s.r.o.
City
Brno - Zidenice
ZIP/Postal Code
615 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmaclinic
City
Brno
ZIP/Postal Code
61141
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologie s.r.o.
City
Brno
ZIP/Postal Code
63800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
L.K.N Arthrocentrum
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Rosypalova, s.r.o
City
Ostrava
ZIP/Postal Code
70800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Arthrohelp S.R.O.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologicky ustav
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Medical Plus S.R.O.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Køge Sygehus Region Sjaelland
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
LTD Clinic LJ
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd New Hospitals
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Consilium Medulla-multiprofile clinic Ltd
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hamburger Rheuma Forschungszentrum II
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Individual Site Status
Completed
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Rheumazentrum Ratingen
City
Ratingen
ZIP/Postal Code
40878
Country
Germany
Individual Site Status
Recruiting
Facility Name
Prince Of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Qualiclinic Kft
City
Budapest
ZIP/Postal Code
H-1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Hifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar-Sava
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Completed
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria di Cagliari
City
Monserrato
ZIP/Postal Code
09124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale Santa Maria Nuova - IRCCS
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Humanitas Hospital
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultan Ismail
City
Johor Bahru
ZIP/Postal Code
81100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tuanku Jaafar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
ClinicMed Daniluk, Nowak Spolka Komandytowa
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Name
Nzoz Bif-Med
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ambulatorium sp. z o.o.
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Badania Kliniczne Sp. z o.o.
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Promed
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermed Centrum Medyczne Sp. z o.o
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne AMED oddzial w Lodzi
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pro Life Medica Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badan Klinicznych
City
Poznan
ZIP/Postal Code
60-446
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia Poznanskie Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Torun
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Warszawa
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Rheuma-Medicus Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Reuma Park
City
Warszawa
ZIP/Postal Code
02-665
Country
Poland
Individual Site Status
Recruiting
Facility Name
ETG Warszawa
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne AMED Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Individual Site Status
Recruiting
Facility Name
WroMedica I.Bielicka, A.Strzałkowska s.c.
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ccab - Hosp. de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Ulsg - Hosp. Sousa Martins
City
Guarda
ZIP/Postal Code
6300-749
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Ipr - Inst. Port. de Reumatologia
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Chlo - Hosp. Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital CUF Tejo
City
Lisboa
ZIP/Postal Code
1350-352
Country
Portugal
Individual Site Status
Completed
Facility Name
Chln - Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Ulsam - Hosp. Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Chsj - Hosp. Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Altay Medical State University
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Chelyabinck Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Sverdlovsk Regional Clinical Hospital N. 1
City
Ekaterinbourg
ZIP/Postal Code
620102
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Regional Clinical Diagnostic Center of Udmurtia Region
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLL Medical Center Revma-Med
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLC Family Outpatient Clinic # 4
City
Korolev
ZIP/Postal Code
141060
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
City
Krasnoyarsk
ZIP/Postal Code
660123
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Clinical-Diagnostic Center Euromedservice, JSC
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
FGBU Research Institute of Rheumatology named V.A.Nasonova
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Llc Ultramed
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBOU VPO Orenburg State Medical University
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBUZ Perm Regional Clinical Hospital
City
Perm
ZIP/Postal Code
614990
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Republican Hospital n.a.V.A.Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Rostov Regional Clinical Dermatovenerological Dispensary
City
Rostov
ZIP/Postal Code
344007
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
St. Petersburg GBUZ Clinical Reumatological Hospital 25
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
X7 Clinical Research Company Limited
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
City
Tolyatti
ZIP/Postal Code
445846
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Republican Clinical Hospital - G.G. Kuvatov
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Clinical Hospital #3
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Reumatologicka ambulancia
City
Nove Mesto nad Vahom
ZIP/Postal Code
91501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Reumatologická ambulancia Thermium s.r.o.
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Reumex s.r.o
City
Rimavska Sobota
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48902
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Completed
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Gaias
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quiron Sagrado Corazon
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset
City
Solna
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Hsin Chu
ZIP/Postal Code
30059
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Phramongkutklao Hospital and Medical College
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Chiang Mai University
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Adana City Hospital
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Completed
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Completed
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
7059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag University Medical Faculty
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Medical Faculty
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Necmettin Erbakan University Meram Medical Faculty
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Khmelnitckiy regional hospital
City
Khmelnytsky
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Terminated
Facility Name
City Clinical Hospital No. 2
City
Kryvyi Rih
ZIP/Postal Code
50056
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center of 'Institute of Rheumatology', LLC
City
Kyiv
ZIP/Postal Code
02081
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Completed
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Individual Site Status
Completed
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Completed
Facility Name
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Terminated
Facility Name
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Individual Site Status
Completed
Facility Name
Health Clinic Limited Liability Company
City
Vinnytsia
ZIP/Postal Code
21009
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center LLC 'Modern Clinic'
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Royal Free London NHS Foundation Trust
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St. Lukes Hospital
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
North Tyneside General Hospital
City
Newcastle
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Haywood Hospital
City
Stoke on Trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
36064592
Citation
Gladman DD, Mease PJ, Bird P, Soriano ER, Chakravarty SD, Shawi M, Xu S, Quinn ST, Gong C, Leibowitz E, Poddubnyy D, Tam LS, Helliwell PS, Kavanaugh A, Deodhar A, Ostergaard M, Baraliakos X. Efficacy and safety of guselkumab in biologic-naive patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial. Trials. 2022 Sep 5;23(1):743. doi: 10.1186/s13063-022-06589-y.
Results Reference
derived

Learn more about this trial

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

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