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Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Study acronym: EVOLUTION
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 150 to 63 Primary and study completion dates: May 2026 to Oct 2026v7 Show 1 more changeShow less
    • Primary and study completion dates: May 2026 to Oct 2026
  2. Study sites: 1 to 14v6
  3. Enrollment target: 300 to 150 Interventions: Golimumab (Drug), Guselkumab (Drug), Placebo (Drug) to Golimumab (Drug), Guselkumab (Drug) · Eligibility criteria expanded, about 77 wordsv5 Show 2 more changesShow less
    • Interventions: Golimumab (Drug), Guselkumab (Drug), Placebo (Drug) to Golimumab (Drug), Guselkumab (Drug)
    • Eligibility criteria expanded, about 77 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2023 to Jul 14, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2023 to Jul 14, 2023
    • Site details revised
  5. Start date: May 2023 to Jun 2023v3
  6. Primary and study completion dates: May 2025 to May 2026 Start date: Feb 2023 to May 2023v2 Show 1 more changeShow less
    • Start date: Feb 2023 to May 2023
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.
Trial Details
NCT Number NCT05669833
Lead Sponsor University of Pennsylvania
Collaborators: Janssen Scientific Affairs, LLC
Conditions Psoriatic Arthritis
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov