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

The Second Hospital of Nanjing Medical University15 enrolled

Overview

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.

Management of Crohn's disease （CD） with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Diseases

Interventions

RapamycinDRUG

Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Response rate

Response was defined as the following criteria: (a) the ability to tolerate a normal diet (vegetable fiber), with a reduction of ≥ 75% in overall baseline target score and sub-score ≤ 2 (Table S1); (b) no need for ED or surgery; (c) no severe adverse events or any other reasons leading to rapamycin withdrawal.

Time frame: up to 24 weeks

Secondary Outcomes

Adverse events

New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)

Time frame: through study completion, an average of 3 years

The rate of surgery or ED after rapamycin

For long-term treatment outcomes, the primary endpoint was the rate of surgery or ED after rapamycin.

Time frame: through study completion, an average of 3 years

Central Contacts

Faming Zhang, MD,PhD

CONTACT

086-25-58509883 fzhang@njmu.edu.cn

Data from ClinicalTrials.gov

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