USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

Summary

Participation Requirements

Description

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 m...

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

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