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A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis (AFFINITY)

Primary Purpose

Arthritis, Psoriatic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Golimumab
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening
  • Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline
  • Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis, with at least one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis
  • Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease
  • Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments
  • Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician
  • Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)
  • Positive human immunodeficiency virus (HIV) antibody test

Sites / Locations

  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Unity Health-White County Medical CenterRecruiting
  • HARAC Research CorpRecruiting
  • Bay Pines VA Healthcare SystemRecruiting
  • Omega Research ConsultantsRecruiting
  • South Coast Research CenterRecruiting
  • Advanced Clinical Research of OrlandoRecruiting
  • Millennium ResearchRecruiting
  • Atlanta Research Center for RheumatologyRecruiting
  • Great Lakes Center of RheumatologyRecruiting
  • ClinvestRecruiting
  • Jacobi Medical CenterRecruiting
  • NYU Langone Ambulatory Care Brooklyn HeightsRecruiting
  • NYU School of MedicineRecruiting
  • University of RochesterRecruiting
  • STAT Research, Inc.Recruiting
  • Trinity Universal Research Associates, LLCRecruiting
  • DM Clinical ResearchRecruiting
  • Swedish Medical CenterRecruiting
  • Frederiksberg HospitalRecruiting
  • Rigshospitalet GlostrupRecruiting
  • Køge Sygehus Region SjaellandRecruiting
  • Silkeborg HospitalRecruiting
  • Vejle SygehusRecruiting
  • Centre Hospitalier Le MansRecruiting
  • Hopital Larrey CHU de ToulouseRecruiting
  • CHU Trousseau - Service de RhumatologieRecruiting
  • Obudai Egeszsegugyi Centrum Kft.Recruiting
  • Bekes Megyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
  • Complex Rendelo Med ZrtRecruiting
  • Vital Medical Center Orvosi es Fogaszati KozpontRecruiting
  • Azienda Ospedaliero-Universitaria di CagliariRecruiting
  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTORecruiting
  • Ospedale San RaffaeleRecruiting
  • IRCCS Policlinico San Matteo, Università degli studi di PaviRecruiting
  • Arcispedale Santa Maria Nuova - IRCCSRecruiting
  • A.O.U.Policlinico Tor VergataRecruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • Università Campus Biomedico di RomaRecruiting
  • AO Ordine MaurizianoRecruiting
  • Centrum Kliniczno Badawcze
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • NZOZ Lecznica MAK-MED. S.C.
  • Centrum Medyczne
  • Medycyna Kliniczna
  • Centrum Medyczne AMED Targowek
  • WroMedica I.Bielicka, A.Strzałkowska s.c.
  • Kemerovo State Medical University
  • LLL Medical Center Revma-Med
  • LLC Family Outpatient Clinic # 4
  • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
  • Orenburg State Medical Academy
  • Rostov Regional Clinical Dermatovenerological Dispensary
  • Ryazan Regional Clinical Dermatovenerological Dispensary
  • Smolensk regional hospital on Smolensk railway station
  • X7 Clinical Research Company Limited
  • Republican Clinical Hospital - G.G. Kuvatov
  • Clinical Hospital #3
  • Hosp. Univ. A CoruñaRecruiting
  • Hosp. Univ. Germans Trias I PujolRecruiting
  • Hosp. Univ. de BasurtoRecruiting
  • Hosp. Reina SofiaRecruiting
  • Hosp. Univ. 12 de OctubreRecruiting
  • Corporacio Sanitari Parc TauliRecruiting
  • Hosp. Clinico Univ. de SantiagoRecruiting
  • Hosp. Virgen MacarenaRecruiting
  • Hosp. Infanta LuisaRecruiting
  • Hosp. Ntra. Sra. de ValmeRecruiting
  • Skanes universitetssjukhusRecruiting
  • Karolinska Universitetssjukhuset SolnaRecruiting
  • State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
  • Municipal Institution Regional hospital-center of emergency care and disasters medicine
  • Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
  • 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
  • Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
  • MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
  • Health Clinic Limited Liability Company
  • Medical Center LLC 'Modern Clinic'

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Guselkumab and Golimumab

Group 2: Guselkumab and Placebo

Arm Description

Participants will receive subcutaneous (SC) guselkumab and golimumab.

Participants will receive SC guselkumab and placebo.

Outcomes

Primary Outcome Measures

Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
MDA defines a satisfactory state of disease activity that includes the 5 domains of psoriatic arthritis (PsA; joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <=1; psoriasis area and severity index (PASI) <=1 or body surface area (BSA) <=3 percent (%); participant's pain visual analog scale (VAS) score of <=15; participant's global disease activity VAS (arthritis and psoriasis) score of <=20; disability index of the health assessment questionnaire (HAQ-DI) score <=0.5; and tender entheseal points <=1.

Secondary Outcome Measures

Percentage of Participants who Achieve American College of Rheumatology (ACR) 50 at Week 24
ACR 50 response is defined as greater than or equal to (>=) 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 the following 5 assessments: participant's assessment of pain using 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 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 c-reactive protein (CRP).
Percentage of Participants who Achieve MDA at Week 16
MDA defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1 or BSA <=3%; participant's pain VAS score of <=15; participant's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI score <=0.5; and tender entheseal points <=1.
Percentage of Participants who Achieve PASI 90 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score from baseline.
Percentage of Participants who Achieve PASI 100 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
Percentage of Participants with an IGA-psoriasis Response of IGA Psoriasis Score of 0 or 1 AND >=2 Grade Reduction From Baseline at Week 24 Among Participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
IGA psoriasis response is defined as an IGA psoriasis score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: 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 HAQ-DI 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 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.
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI >0.
Percentage of Participants with Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline
The presence and severity of dactylitis is assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results are summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Change from Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a 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.
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Reasonably Related AEs
Percentage of participants with AEs, SAEs, and 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.
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Percentage of Participants With Infections
Percentage of participants with infections will be reported.
Percentage of Participants With Injection-site Reactions
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.
Serum Guselkumab and Golimumab Concentration
Serum guselkumab and golimumab concentration will be measured.
Percentage of Participants with Antibodies to Guselkumab or Golimumab
Percentage of participants with antibodies to guselkumab or golimumab will be reported.

Full Information

First Posted
September 6, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05071664
Brief Title
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
Acronym
AFFINITY
Official Title
A Phase 2a, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
May 22, 2024 (Anticipated)
Study Completion Date
August 13, 2024 (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
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.
Detailed Description
PsA is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. Guselkumab is a fully human monoclonal antibody (mAb) directed against the p19 subunit of interleukin (IL)-23, 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. Golimumab is a fully human anti-TNF-alpha mAb that binds to TNF-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of TNF-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including PsA. This study will consist of a Screening Phase (up to 6 weeks), Double-blind Phase from Weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (Week 24), and Safety Follow-up Phase from Week 24 to Week 36. Key safety assessments will include adverse events (AEs), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (TB). The total duration of the study is up to 42 weeks.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab and Golimumab
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) guselkumab and golimumab.
Arm Title
Group 2: Guselkumab and Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive SC guselkumab and placebo.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
TREMFYA, CNTO1959
Intervention Description
Guselkumab will be administered as a SC injection.
Intervention Type
Drug
Intervention Name(s)
Golimumab
Other Intervention Name(s)
SIMPONI, CNTO148
Intervention Description
Golimumab will be administered as a SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as a SC injection.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve Minimal Disease Activity (MDA) at Week 24
Description
MDA defines a satisfactory state of disease activity that includes the 5 domains of psoriatic arthritis (PsA; joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <=1; psoriasis area and severity index (PASI) <=1 or body surface area (BSA) <=3 percent (%); participant's pain visual analog scale (VAS) score of <=15; participant's global disease activity VAS (arthritis and psoriasis) score of <=20; disability index of the health assessment questionnaire (HAQ-DI) score <=0.5; and tender entheseal points <=1.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve American College of Rheumatology (ACR) 50 at Week 24
Description
ACR 50 response is defined as greater than or equal to (>=) 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 the following 5 assessments: participant's assessment of pain using 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 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 c-reactive protein (CRP).
Time Frame
Week 24
Title
Percentage of Participants who Achieve MDA at Week 16
Description
MDA defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, participant's assessment of pain and disease activity, physical function, and enthesitis). Participants are classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count <=1; swollen joint count <=1; PASI <=1 or BSA <=3%; participant's pain VAS score of <=15; participant's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI score <=0.5; and tender entheseal points <=1.
Time Frame
Week 16
Title
Percentage of Participants who Achieve PASI 90 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response is defined as >=90% improvement in PASI score from baseline.
Time Frame
Week 24
Title
Percentage of Participants who Achieve PASI 100 at Week 24 Among the Participants with >=3% BSA Psoriatic involvement and an IGA Score of >=2 (Mild) at Baseline
Description
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
Time Frame
Week 24
Title
Percentage of Participants with an IGA-psoriasis Response of IGA Psoriasis Score of 0 or 1 AND >=2 Grade Reduction From Baseline at Week 24 Among Participants with >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description
IGA psoriasis response is defined as an IGA psoriasis score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: 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 HAQ-DI 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 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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline
Description
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI >0.
Time Frame
Week 24
Title
Percentage of Participants with Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline
Description
The presence and severity of dactylitis is assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results are summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with the baseline dactylitis score >0.
Time Frame
Week 24
Title
Change from Baseline in Short Form Health Survey (SF-36) Physical Component Score (PCS) at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Reasonably Related AEs
Description
Percentage of participants with AEs, SAEs, and 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.
Time Frame
Up to 42 weeks
Title
Percentage of Participants With AEs Leading to Discontinuation of Study Intervention
Description
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 42 weeks
Title
Percentage of Participants With Infections
Description
Percentage of participants with infections will be reported.
Time Frame
Up to 42 weeks
Title
Percentage of Participants With Injection-site Reactions
Description
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.
Time Frame
Up to Week 20
Title
Serum Guselkumab and Golimumab Concentration
Description
Serum guselkumab and golimumab concentration will be measured.
Time Frame
Up to Week 36
Title
Percentage of Participants with Antibodies to Guselkumab or Golimumab
Description
Percentage of participants with antibodies to guselkumab or golimumab will be reported.
Time Frame
Up to Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis Have active plaque psoriasis, with at least one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period) Exclusion Criteria: Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician Has received more than 2 prior anti-TNF-alpha agents (or biosimilars) Positive human immunodeficiency virus (HIV) antibody test
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 and Rheumatology Research, PLLC
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
Unity Health-White County Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Individual Site Status
Recruiting
Facility Name
HARAC Research Corp
City
Avon Park
State/Province
Florida
ZIP/Postal Code
33825
Country
United States
Individual Site Status
Recruiting
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
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
South Coast Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research of Orlando
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Research Center for Rheumatology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Center of Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
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
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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
Recruiting
Facility Name
Trinity Universal Research Associates, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
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
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
Silkeborg Hospital
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Larrey CHU de Toulouse
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Trousseau - Service de Rhumatologie
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Complex Rendelo Med Zrt
City
Szekesfehervar
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
Azienda Ospedaliero-Universitaria di Cagliari
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Policlinico San Matteo, Università degli studi di Pavi
City
Pavia
ZIP/Postal Code
27100
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
A.O.U.Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università Campus Biomedico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
AO Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Individual Site Status
Completed
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Completed
Facility Name
Medycyna Kliniczna
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Medyczne AMED Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Individual Site Status
Completed
Facility Name
WroMedica I.Bielicka, A.Strzałkowska s.c.
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Completed
Facility Name
Kemerovo State Medical University
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
LLL Medical Center Revma-Med
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
LLC Family Outpatient Clinic # 4
City
Korolev
ZIP/Postal Code
141060
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
Completed
Facility Name
Orenburg State Medical Academy
City
Orenburg
ZIP/Postal Code
460000
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
Ryazan Regional Clinical Dermatovenerological Dispensary
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Smolensk regional hospital on Smolensk railway station
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
X7 Clinical Research Company Limited
City
St. Petersburg
ZIP/Postal Code
194156
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
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Barcelona
ZIP/Postal Code
08916
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. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
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. Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Ntra. Sra. de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Skanes universitetssjukhus
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset Solna
City
Solna
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Municipal Institution Regional hospital-center of emergency care and disasters medicine
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud
City
Kyiv
ZIP/Postal Code
03037
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
Terminated
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
Terminated
Facility Name
Municipal Non-Profit Enterprise of Kyiv Regional Council 'Kyiv regional Clinical Hospital'
City
Kyiv
ZIP/Postal Code
04107
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
Terminated
Facility Name
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Terminated
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

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

Learn more about this trial

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

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