deltatrials
Active Not Recruiting PHASE4 INTERVENTIONAL 2-arm NCT04496063

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) (USTAP)

USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Updated 11 times since 2020 Last updated: Jul 19, 2024 Started: Nov 16, 2020 Primary completion: Jun 30, 2025 Completion: Dec 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04496063, this PHASE4 trial focuses on Crohn's Disease and remains ongoing. Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, it has been updated 11 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Main endpoint: The primary endpoint will be combined remission at week 12 defined as: * 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression) And * absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI Patient requiring UST optimization will be considered in failure but will be followed until week 48 Secondary endpoints: Definition * Clinical remission: 100% of the fistula tracts without any drainage by the external openings (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) * Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) * Radiological remission: absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI * Combined clinical and radiological remission at week 24 and 48. * Clinical remission (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) at week 12, 24 and 48 * Absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI at week 12, 24 and 48 * Evaluation of the magnetic...

Main endpoint:

The primary endpoint will be combined remission at week 12 defined as:

* 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression) And * absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI Patient requiring UST optimization will be considered in failure but will be followed until week 48

Secondary endpoints:

Definition

* Clinical remission: 100% of the fistula tracts without any drainage by the external openings (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) * Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) * Radiological remission: absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI * Combined clinical and radiological remission at week 24 and 48. * Clinical remission (i.e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) at week 12, 24 and 48 * Absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI at week 12, 24 and 48 * Evaluation of the magnetic resonance novel index for fistula imaging in CD at week 12, 24 and 48 * Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) at week 12, 24 and 48 * Combined clinical response and radiological remission at week 48 * Perineal Disease Activity Index (PDAI), Crohn Disease Activity Index (CDAI) at week 12, 24 and 48 * Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire (IBDQ) scores at week 24 and 48 * Correlation between response and remission and UST trough levels and antidrug (UST) antibodies at week 12, 24, 48 * Clinical response of UST optimization at week 48 (closure of at least 50% of all treated external openings that were draining at week 12) * Clinical response at week 48 of UST introduction at W12 (closure of at least 50% of all treated external

Status Flow

~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotNot Yet Recruiting~Feb 2021 – ~Jun 2022 · 16 months · monthly snapshotRecruiting~Jun 2022 – ~Jun 2023 · 12 months · monthly snapshotRecruiting~Jun 2023 – ~Feb 2024 · 8 months · monthly snapshotRecruiting~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshotRecruiting~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshotRecruiting~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshotActive Not Recruiting~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotActive Not Recruiting~Sep 2025 – present · 7 months · monthly snapshotActive Not Recruiting~Jan 2026 – present · 3 months · monthly snapshotActive Not Recruiting

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Active Not Recruiting PHASE4

  2. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE4

  3. Sep 2024 — Sep 2025 [monthly]

    Active Not Recruiting PHASE4

  4. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

  5. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE4

Show 6 earlier versions
  1. Feb 2024 — Jul 2024 [monthly]

    Recruiting PHASE4

  2. Jun 2023 — Feb 2024 [monthly]

    Recruiting PHASE4

  3. Jun 2022 — Jun 2023 [monthly]

    Recruiting PHASE4

  4. Feb 2021 — Jun 2022 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  5. Jan 2021 — Feb 2021 [monthly]

    Not Yet Recruiting PHASE4

  6. Sep 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Janssen, LP
Data source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

For direct contact, visit the study record on ClinicalTrials.gov .