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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04882098
Registration number
NCT04882098
Ethics application status
Date submitted
10/05/2021
Date registered
11/05/2021
Date last updated
10/10/2025
Titles & IDs
Public title
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
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Scientific title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis
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Secondary ID [1]
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CNTO1959PSA3004
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Secondary ID [2]
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CR108957
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Universal Trial Number (UTN)
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Trial acronym
APEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo
Experimental: Group 1: Guselkumab and Placebo - Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.
Experimental: Group 2: Guselkumab - Participants will receive guselkumab SC. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Experimental: Group 3: Placebo Followed by Guselkumab - Participants will receive placebo SC and will cross over to receive SC guselkumab. Participants who have not discontinued will be eligible to enter an LTE and will receive guselkumab SC.
Treatment: Drugs: Guselkumab
Participants will receive guselkumab as SC injection.
Treatment: Drugs: Placebo
Participants will receive matching placebo as SC injection.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
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Assessment method [1]
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The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter \[mm\], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, \[0 mm= very well to 100 mm= very poor\]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), \[0 = no arthritis to 100 = extremely active arthritis\], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24
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Assessment method [1]
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Modified vdH-S score is the sum of the erosion score (hand, feet) and joint space narrowing (JSN) score (hand, feet). Total score ranges from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score indicates more joint damage. Positive changes from baseline in the modified vdH-S total, erosion and JSN scores indicate progression of joint damage.
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
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Assessment method [2]
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Number of Participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
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Timepoint [2]
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Up to 168 weeks
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Secondary outcome [3]
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Number of Participants with AEs leading to Discontinuation of Study Intervention
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Assessment method [3]
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Number of participants with AEs leading to discontinuation of study intervention will be reported.
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Timepoint [3]
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Up to 168 weeks
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Secondary outcome [4]
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Number of Participants with Infections
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Assessment method [4]
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Number of participants with infections will be reported.
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Timepoint [4]
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Up to 168 weeks
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Secondary outcome [5]
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Number of Participants with AEs Temporally Associated With an Injection-site Reactions
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Assessment method [5]
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Number of participants with AEs temporally associated with an injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site. 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.
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Timepoint [5]
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Up to 168 weeks
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Secondary outcome [6]
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Number of Participants With Change from Baseline in Clinical Laboratory Abnormalities
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Assessment method [6]
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Number of participants with change from baseline in clinical laboratory abnormalities including hematology and chemistry will be reported.
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Timepoint [6]
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Baseline, up to 168 weeks
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Secondary outcome [7]
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Number of Participants with Maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade Laboratory Values
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Assessment method [7]
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Number of participants with maximum CTCAE toxicity grade laboratory values 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.
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Timepoint [7]
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Up to 168 weeks
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Secondary outcome [8]
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Serum Guselkumab Concentration
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Assessment method [8]
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Serum guselkumab concentration will be measured.
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Timepoint [8]
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Up to 168 weeks
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Secondary outcome [9]
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Number of Participants with Anti-guselkumab Antibodies
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Assessment method [9]
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Number of participants with anti-guselkumab antibodies to guselkumab will be reported.
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Timepoint [9]
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Up to 168 weeks
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Eligibility
Key inclusion criteria
* Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* Have a diagnosis of PsA for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
* Have active PsA as defined by: at least 3 swollen joints and 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory
* Have >= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read
* Have at least one 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has known allergies, hypersensitivity, or intolerance to study intervention 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), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease
* Has previously received any biologic treatment
* Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/05/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
1054
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [2]
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Southern Clinical Research - Hobart
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Emeritus Research - Melbourne
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Recruitment hospital [4]
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Eastern Health - Box Hill Hospital - Melbourne
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Recruitment hospital [5]
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Rheumatology Research Unit - Sunshine Coast
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Recruitment postcode(s) [1]
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5011 - Adelaide
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Recruitment postcode(s) [2]
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7000 - Hobart
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Recruitment postcode(s) [3]
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3124 - Melbourne
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Recruitment postcode(s) [4]
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3128 - Melbourne
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Recruitment postcode(s) [5]
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4558 - Sunshine Coast
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Recruitment outside Australia
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United States of America
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Alabama
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Mostar
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Sarajevo
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Plovdiv
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Israel
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Israel
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Israel
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Ramat Gan
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Israel
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Petaling Jaya
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Angeles
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Cebu
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Philippines
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Las Piñas
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Philippines
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Manila
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Bialystok
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Bydgoszcz
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Elblag
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Gdynia
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Krakow
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Lublin
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Nadarzyn
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Nowa Sól
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Poznan
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Torun
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Chelyabinsk
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Kemerovo
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Moscow
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Russia
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Orenburg
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Petrozavodsk
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Saint Petersburg
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Ulyanovsk
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Vladimir
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Russia
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Niška Banja
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Serbia
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Novi Sad
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Košice
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Martin
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Slovakia
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Izo
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Ljubljana
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Gwangju
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Seoul
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Suwon
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Spain
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A Coruña
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Córdoba
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Madrid
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Murcia
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Seville
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Taichung
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Istanbul
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Kharkiv
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Kiev
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Kryvyi Rih
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Kyiv
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Odesa
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Ternopil
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Zhytomyr
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
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Trial website
https://clinicaltrials.gov/study/NCT04882098
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Trial related presentations / publications
Ritchlin CT, Coates LC, Mease PJ, van der Heijde D, Song J, Jiang Y, Shawi M, Kollmeier AP, Rahman P. The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2023 Jan 10;24(1):22. doi: 10.1186/s13063-022-06945-y.
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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0
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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0
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Phone
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844-434-4210
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Email
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0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinicaltrials/ 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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04882098
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