Treatment of active anal fistulas in Crohn's disease with Upadacitinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of Upadacitinib, a small molecule drug, in treating active anal fistulas in patients with Crohn's disease. It focuses on a single-center, single-arm approach to include patients diagnosed with moderate to severe Crohn's disease who also have confirmed active anal fistulas. The study aims to address the high incidence of anal fistulas in Asian populations, which is often underrepresented in existing research. By utilizing Upadacitinib, the study seeks to provide a more effective oral treatment option compared to traditional biologics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years and ≤70 years;
* Make a clear diagnosis of CD according to the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)";
* The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \> 220.
* Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid seepage and other symptoms, and the transanal surgeon judges that the symptoms are related to anal fistula activity;
* Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging;
* Informed consent. The subjects gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent.

Exclusion Criteria:

* History of allergy to the active ingredient of upatinib;
* Severe damage of liver and kidney function; Hemoglobin \< 8g/L;
* History of malignant tumor;
* Patients with previous thrombosis;
* Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L;
* Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE/MRE.
* Presence of enterostomy;
* With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles);
* Pregnant or planning pregnancy.
* Patients with vaginal fistula;
* Patients with anorectal stenosis.

Where it's running

• Sixth afflicated of Sun-yat sen university
  Guangzhou, Guangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.