Active Perianal Fistulizing Crohn's Disease
Conditions
Interventions
Active Perianal Fistulizing Crohn's Disease Refractory to Anti-TNF Therapy:None
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female patients aged 18-60 years (inclusive) at Baseline (Week 0), exclusively of Chinese ancestry. 2. Confirmed diagnosis of Crohn’s disease >=3 months prior to Baseline (Week 0), established by endoscopy, radiological assessment, and/or histopathology. 3. Documented failure to >=1 anti-TNFa agent: a.Infliximab: >=6-week induction regimen (IV >=5 mg/kg at Weeks 0, 2, and 6) b.Adalimumab: >=4-week induction regimen (SC 160 mg at Week 0 + 80 mg at Week 2); 4. MRI-confirmed active perianal fistula at Baseline (Week 0). 5. Negative tuberculosis (TB) screening. Subjects with latent TB must complete =3 weeks of TB prophylaxis prior to Baseline. 6. Willing and able to provide written informed consent and comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of ulcerative colitis (UC) or indeterminate colitis. 2. Pregnancy or breastfeeding. 3. Severe systemic diseases, opportunistic infections, immunodeficiency, malignancy history, or demyelinating disorders. 4. History or current venous/arterial thrombosis (e.g., DVT, PE). 5. History of myocardial infarction, stroke, or moderate-severe heart failure (NYHA III/IV) within 6 months. 6. Severe hepatic impairment (Child-Pugh C) or severe renal impairment/ESRD. 7. At Baseline (Week 0): ALC 20 mg/day. 11. Previous treatment with JAK inhibitors (e.g., tofacitinib, baricitinib). 12. Ileostomy, ileoanal pouch, or short bowel syndrome. 13. Bowel resection or abdominal surgery within 3 months prior to Baseline. 14. Known allergy to upadacitinib or its excipients. 15. Any condition deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| combined fistula remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Calprotectin;Visual Analogue Scale;clinical fistula response;Wexner Fecal Incontinence Score;Combines clinical remission and endoscopic response;endoscopic remission;Perianal Disease Activity Index (PDAI);CRP; | — |
Countries
China
Contacts
Public ContactCao Zhijun
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed