A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

Sponsor
Janssen Pharmaceutica N.V., Belgium
Study ID
NCT03796858
Phase
PHASE3
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab 100 mg — DRUG
    Participants will receive guselkumab 100mg as SC injection.
  • Placebo — DRUG
    Participants will receive placebo as SC injection.

Study Details

The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.

Key Dates

Start date
Mar 22, 2019
Status verified
Jan 2025
Primary completion
Nov 11, 2020
Completion
Nov 11, 2020

Study Design

Enrollment
285 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Guselkumab
    Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).
  • Experimental: Group 2: Placebo followed by Guselkumab
    Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.

Primary Outcome Measure

Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ]

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