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

Primary Purpose

Crohn's Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rapamycin
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Diseases focused on measuring rapamycin, stricture, fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upper gastrointestinal strictures

Lower gastrointestinal strictures

Arm Description

Patients with upper gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.

Patients with lower gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2016
Last Updated
October 2, 2020
Sponsor
The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02675153
Brief Title
To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture
Official Title
Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Diseases
Keywords
rapamycin, stricture, fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upper gastrointestinal strictures
Arm Type
Experimental
Arm Description
Patients with upper gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.
Arm Title
Lower gastrointestinal strictures
Arm Type
Experimental
Arm Description
Patients with lower gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months.
Intervention Type
Drug
Intervention Name(s)
Rapamycin
Other Intervention Name(s)
Sirolimus
Intervention Description
Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.
Primary Outcome Measure Information:
Title
Response rate
Description
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 Outcome Measure Information:
Title
Adverse events
Description
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
Title
The rate of surgery or ED after rapamycin
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese patients (≥18 years of age) with a documented definite diagnosis of CD; the presence of a clinically symptomatic stricture; strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE). Exclusion Criteria: 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; Patients who were not followed up between the inception of medication and any other subsequent treatments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faming Zhang, MD,PhD
Phone
086-25-58509883
Email
fzhang@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD,PhD
Organizational Affiliation
The Second Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD, PhD
Phone
086-25-58509883
Email
fzhang@njmu.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
25240477
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.
Results Reference
background
PubMed Identifier
18719139
Citation
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.
Results Reference
background

Learn more about this trial

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

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