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โ† Trials
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Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

RecruitingPhase 1Ages 18 Years - 70 YearsAllSixth Affiliated Hospital, Sun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatment of CD active anal fistula is difficult, which seriously affects the quality of life of patients and consumes a lot of medical resources. Injection of biological agents is the most commonly used method for the treatment of CD anal fistula, small molecule drugs can be taken orally, and the curative effect is more lasting. Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023. At present, there is only one post-subgroup analysis of a global Phase 3 clinical study on Upatinib in the treatment of CD anal fistula, and the number of active anal fistula cases included is small, and the study objects are mostly western populations. This study intends to

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years and โ‰ค70 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 \< 1ร—109/L; , or lymphocyte count \< 500ร—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.
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What it tests

  • Upadacitinib
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Where

1 site
Sixth afflicated of Sun-yat sen university
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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