Multicentre, prospective, observational study on the effectiveness and safety of upadacitinib for active perianal fistulising Crohn's disease in patients with prior anti-tumour necrosis factor failure: a study protocol.

What To Know

This is a study protocol (abstract) reporting planned real-world enrollment of 90 adults with active draining perianal fistulas refractory to prior infliximab or adalimumab.

Participants will receive upadacitinib induction (45 mg/day) then maintenance dosing (15 or 30 mg/day) per clinical practice; concomitant therapies and dosing decisions are not mandated by the protocol.

The primary endpoint is a composite clinical and radiological fistula response at week 12, with secondary safety and disease-related outcomes collected through week 52. The study excludes patients with severe luminal disease, large undrained abscesses (>2 cm), anal stenosis, or diverting stomas.

Ethics approval and trial registration (ChiCTR2600117355) are reported. Results are not presented in this abstract; it is a protocol describing planned observational data collection.