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

Crohn's Diseases Clinical Trial

Official title:

Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02675153
• Other study ID #: RAPA-CN-160122
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: October 2020

Study information

• Verified date: October 2020
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD,PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Crohn Disease
• Crohn's Diseases

Intervention

Drug:
• Rapamycin
Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Massey DC, Bredin F, Parkes M. Use of sirolimus (rapamycin) to treat refractory Crohn's disease. Gut. 2008 Sep;57(9):1294-6. doi: 10.1136/gut.2008.157297. — View Citation

Mutalib M, Borrelli O, Blackstock S, Kiparissi F, Elawad M, Shah N, Lindley K. The use of sirolimus (rapamycin) in the management of refractory inflammatory bowel disease in children. J Crohns Colitis. 2014 Dec;8(12):1730-4. doi: 10.1016/j.crohns.2014.08.014. Epub 2014 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 24 weeks
Secondary	Adverse events	New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)	through study completion, an average of 3 years
Secondary	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.	through study completion, an average of 3 years