perianal fistulizing Crohn’s disease
Conditions
Interventions
Upadacitinib Treatment Group:None
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years. 2.A confirmed diagnosis of CD based on clinical presentation, laboratory tests, imaging, endoscopy, and histopathology, in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Crohn’s Disease (2023, Guangzhou). 3.Presence of at least one actively draining perianal fistula persisting for >4 weeks, confirmed by pelvic magnetic resonance imaging (MRI). 4.Perianal Disease Activity Index (PDAI) score >5. 5.Adult patients with moderate-to-severe active CD who have had an inadequate response, intolerance, or contraindication to one or more tumor necrosis factor (TNF) inhibitors. 6.Willingness to participate in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Presence of inadequately drained perianal abscess or fluid collection at baseline, defined as a maximum diameter >2 cm (fluid component only), requiring further surgical intervention as assessed by the investigator. 2.Severe anal or rectal stenosis precluding endoscopic or necessary assessments. 3.Presence of rectovaginal fistula or prior history of ileal pouch–anal anastomosis. 4.Severe intestinal complications requiring urgent or elective surgery, including symptomatic bowel obstruction or high-risk strictures, and active intra-abdominal or pelvic abscess. 5.Short bowel syndrome or other conditions significantly affecting drug absorption. 6.Known hypersensitivity to UPA or any of its excipients, or presence of contraindications as specified in the prescribing information (e.g., severe infection, active tuberculosis). 7.Vulnerable populations, including individuals with psychiatric disorders, cognitive impairment, critically ill patients, pregnant women, and illiterate individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite remission of perianal fistulas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission;Clinical remission;Safety; | — |
Countries
China
Contacts
Public ContactQian Cao
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed