To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture

• Status: Recruiting
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Second Hospital of Nanjing Medical University
• Collaborator: Xijing Hospital of Digestive Diseases
• Treatments: Azathioprine; Everolimus; Infliximab; Prednisone; Sirolimus

Criteria

Inclusion Criteria:

1. Chinese patients (≥18 years of age) with a documented definite diagnosis of CD;

2. the presence of a clinically symptomatic stricture;

3. strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE).

Exclusion Criteria:

1. Patients who were pregnant, diagnosed with intestinal perforation, complete intestinal obstruction, any signs of dysplasia or malignancy, or use of anti-tumor necrosis factor (TNF) in the last three months;

2. Patients who were not followed up between the inception of medication and any other subsequent treatments.