Clinical trial NCT02319759: Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)
Official title: A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
Guselkumab
Ustekinumab
Placebo
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-12-18
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Detailed description: This is a multi-center (more than one clinical site will work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study to determine the efficacy and safety of guselkumab in participants with PsA. The study will consist of 4 parts: Screening period (6 weeks), a double-blind treatment period (consists of guselkumab and placebo treatment for 24 weeks), an active treatment period (guselkumab for 20 weeks), and follow-up period (12 weeks). The maximal study duration for a participant will not exceed 62 weeks including the Screening period. Eligible participants will be randomly assigned to one of two groups in a 2:1 ratio to either receive Guselkumab 100 milligram (mg) at Weeks 0, 4 then every 8 weeks or Placebo at Weeks 0, 4 then every 8 weeks until Week 24. At week 24, participants remaining in the placebo group will start to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44. Participants in both treatment groups who have less than (\<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 will qualify for early escape and will switch to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication in the particular country of study. The efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response at Week 24. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
* Had active PsA as defined by:

  1. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
  2. C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
* Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
* Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (\>=) 3% at Screening and baseline
* Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
* If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

Exclusion Criteria:

* Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
* Has previously received guselkumab or ustekinumab
* Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
* Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
* Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

Primary outcomes:
measure: Percentage of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-75 Response at Week 24
timeFrame: Week 24
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved an ACR 20 Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who an Achieved ACR 50 Response at Week 24
timeFrame: Week 24
measure: Percent Change From Baseline in Leeds Enthesitis Index (LEI) Scores Among Participants With Enthesitis at Week 24
timeFrame: Baseline and Week 24
measure: Percent Change From Baseline in Dactylitis Scores Among Participants With Dactylitis at Baseline at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Who Achieved ACR 20, ACR 50, and ACR 70 Responses at Weeks 24, 28, 32, 36, 44, and 56
timeFrame: Weeks 24, 28, 32, 36, 44, and 56
measure: Percent Change From Baseline in the ACR Components at Weeks 12 and 24
timeFrame: Baseline and Weeks 12, 24
measure: Percent Change From Baseline in the ACR Components at Weeks 24, 28, 32, 36, 44 and 56
timeFrame: Basline and Weeks 24, 28, 32, 36, 44, 56
measure: Change From Baseline in HAQ-DI Response at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24
measure: Change From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56
timeFrame: Baseline and Weeks 24, 28, 32, 36, 44, 56
measure: Percentage of Participants Who Achieved a HAQ-DI Response With Greater Than or Equal to (>=) 0.3 Improvement From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20, and 24
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Who Achieved an HAQ-DI Response With >= -0.3 Improvement From Baseline in HAQ-DI Score at Weeks 24, 28, 32, 36, 44, and 56
timeFrame: Weeks 24, 28, 32, 36, 44, 56
measure: Percent Change From Baseline in Dactylitis Scores at Weeks 4, 8, 16, and 24
timeFrame: Baseline and Weeks 4, 8, 16, 24
measure: Percent Change From Baseline in Dactylitis Scores at Weeks 24, 28, 32, 44, 56
timeFrame: Baseline and Weeks 24, 28, 32, 44, 56
measure: Percentage of Participants With Dactylitis at Weeks 4, 8, 16, and 24
timeFrame: Weeks 4, 8, 16, and 24
measure: Percentage of Participants With Dactylitis at Weeks 24, 28, 32, 44, and 56
timeFrame: Weeks 24, 28, 32, 44, and 56
measure: Percent Change From Baseline in LEI Scores at Week 4, 8, 16, and 24
timeFrame: Baseline and Weeks 4, 8, 16, 24
measure: Percent Change From Baseline in LEI Scores at Weeks 24, 28, 32, 44, and 56
timeFrame: Baseline and Weeks 24, 28, 32, 44, 56
measure: Percentage of Participants With Enthesitis Based on LEI Score at Weeks 4, 8, 16, and 24 in Participants With Enthesitis at Baseline
timeFrame: Weeks 4, 8, 16, and 24
measure: Percentage of Participants With Enthesitis Based on LEI at Weeks 24, 28, 32, 44, and 56 in Participants With Enthesitis at Baseline
timeFrame: Weeks 24, 28, 32, 44, and 56
measure: Change From Baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) Score at Weeks 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in PASDAS Score at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in GRAppa Composite scorE (GRACE) Index Score at Weeks 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in GRACE Index Score at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) Score at Weeks 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in mCPDAI Index Score at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24
measure: Change From Baseline in DAPSA Index Score at Weeks 24, 28, 32, 36, 44, and 56
timeFrame: Baseline and Weeks 24, 28, 32, 36, 44, 56
measure: Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved MDA at Weeks 24 and 44
timeFrame: Weeks 24 and 44
measure: Change From Baseline in the Physical and Mental Component Summary (PCS and MCS) Scores of 36- Item Short Form Health Assessment Questionnaire (SF-36) at Weeks 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in the PCS Scores of SF-36 at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in the MCS Scores of SF-36 at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in Norm-based SF-36 Scales at Week 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in Norm-based SF-36 Scale at Week 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Weeks 16 and 24
timeFrame: Baseline and Weeks 16, 24
measure: Change From Baseline in RAPID3 Score at Weeks 24 and 44
timeFrame: Baseline and Weeks 24, 44
measure: Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 16 and 24
timeFrame: Weeks 16 and 24
measure: Percentage of Participants Who Achieved a PASI 50, PASI 75, PASI 90 and PASI 100 Response at Weeks 24, 28, 32, 44, and 56
timeFrame: Weeks 24, 28, 32, 44, and 56
measure: Percent Change From Baseline in PASI Score at Weeks 4, 8, 16, and 24
timeFrame: Baseline and Weeks 4, 8, 16, 24
measure: Percent Change From Baseline in PASI Score at Weeks 24, 28, 32, 44, and 56
timeFrame: Baseline and Weeks 24, 28, 32, 44, 56
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Trumbull
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Sandy Springs
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Wyomissing
country: United States
state: Pennsylvania
city: Jackson
country: United States
state: Tennessee
city: Arlington
country: United States
state: Virginia
city: Barrie
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Waterloo
country: Canada
state: Ontario
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Herne
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Lubeck
country: Germany
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Bucharest
country: Romania
city: Bataysk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Ufa
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sabadell
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Gladman DD, Deodhar A, McGonagle DG, Nash P, Boehncke WH, Gottlieb A, Xu XL, Xu S, Hsia EC, Karyekar CS, Helliwell PS. Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. RMD Open. 2020 Jul;6(2):e001217. doi: 10.1136/rmdopen-2020-001217.
citation: Helliwell PS, Deodhar A, Gottlieb AB, Boehncke WH, Xu XL, Xu S, Wang Y, Hsia EC, Gladman DD, Ritchlin CT. Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1579-1588. doi: 10.1002/acr.24046.
citation: Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, Barchuk W, Xu XL, Hsia EC; CNTO1959PSA2001 Study Group. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018 Jun 2;391(10136):2213-2224. doi: 10.1016/S0140-6736(18)30952-8. Epub 2018 Jun 1.