Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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 include CD patients with active anal fistula, and adopts the method of single-center single-arm study to explore the efficacy of Upatinib in the treatment of CD anal fistula, so as to provide more evidence-based medical evidence for the drug selection of CD anal fistula in China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Upadacitinib
DrugEnrolled patients received oral upatinib treatment with a conventional induction dose of 45mg/d for 12 weeks, followed by a maintenance dose of 15m/d or 30mg/d
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: The primary endpoint was the combined response rate at 12 weeks of treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Clinical response at 12 weeks of treatment
Clinical response was defined as 100% closure of the external orifice of the fistula and no fluid seepage from the patient's complaint or physician's acupressure
Time frame
12 weeks2
Imaging remission at 12 weeks of treatment
Imaging remission was defined as the absence of \> 2 cm pyo-filling fistula on perianal MRI and the absence of edema and active inflammation
Time frame
12 weeksSecondary outcomes
1
The clinical response rate of anal fistula at week 12/48 of treatment.
Clinical response: At least 50% of the external openings with exudate upon digital pressure at baseline are closed
Time frame
12 weeks、48 weeks2
The clinical remission rate of anal fistula at week 12/48 of treatment.
Clinical remission: The patient has no symptoms of perianal fistula exudate, and 100% of the external openings show no exudate upon digital pressure by the doctor.
Time frame
12 weeks、48 weeks3
The imaging remission rate of anal fistula at week 12/48 of treatment
Imaging remission: No abscess fistula larger than 2 cm is found on perianal MRI, and there is no edema or active inflammation (judged blindly by one radiologist).
Time frame
12 weeks、48 weeks4
The Perianal Disease Activity Index score at week 12/48 of treatment
Perianal Disease Activity Index(PDAI) is the core tool for evaluating perianal lesions in Crohn's disease, with a total score ranging from 0 to 20. A higher score indicates more severe perianal disease activity and a poorer prognosis
Time frame
12 weeks、48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov