NCT02675153

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5.5 years

First QC Date

January 21, 2016

Last Update Submit

October 2, 2020

Conditions

Crohn's Diseases

Keywords

rapamycinstricturefibrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events

    through study completion, an average of 3 years

  • The rate of surgery or ED after rapamycin

    through study completion, an average of 3 years

Study Arms (2)

Upper gastrointestinal strictures

EXPERIMENTAL

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

Drug: Rapamycin

Lower gastrointestinal strictures

EXPERIMENTAL

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

Drug: Rapamycin

Interventions

RapamycinDRUG

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

Also known as: Sirolimus
Lower gastrointestinal stricturesUpper gastrointestinal strictures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 25240477BACKGROUND

  • 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.

    PMID: 18719139BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseConstriction, PathologicFibrosis

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Faming Zhang, MD,PhD

    The Second Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Gastroenterology

Study Record Dates

First Submitted

January 21, 2016

First Posted

February 5, 2016

Study Start

April 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

CN(1)