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USTAPNCT04496063

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

StatusCompleted
PhasePhase 4
Primary completion
Track this trial

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 35 words Show 5 more changesShow less
    • Trial status changed: Unknown → Completed
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description expanded, about 16 words
    • Site details revised at 1 of 20 sites
    • Publications: details revised at 2 of 2 entries
  2. Changed Registry marked status Unknown; last known: Active, Not Recruiting
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2025v6 Show 4 more changesShow less
    • Trial status: Recruiting to Unknown
    • Enrollment target: estimated 146 to confirmed 33
    • Study completion date: Jun 30, 2025 to Dec 30, 2025
    • Site details revised at 20 of 20 sites
  4. Primary completion date: Dec 2, 2023 to Jun 30, 2024
    • Study completion date: Sep 2, 2024 to Jun 30, 2025
    v5
  5. Primary completion date: Dec 2, 2022 to Dec 2, 2023
    • Study completion date: Sep 2, 2023 to Sep 2, 2024
    v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 21 to 20
    • Start date changed from estimate of Sep 2, 2020 to Nov 16, 2020
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Combined clinical and radiological remission
Timeframe: Week 12

Secondary (9)

Combined clinical and radiological remission
Clinical response
MAGNIFI-CD26
PDAI
IBDQ scores
Show 4 moreShow less
UST trough levels and antidrug
Clinical response of UST optimization
Clinical response of UST introduction at week 12
CDAI

Arms and interventions

Group 1 UstekinumabExperimental

Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks

Group 2 PlaceboPlacebo comparator

Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Drugs: Ustekinumab, Placebo

Sites

20 sites in 1 country