Biologics for Stricturing Crohn's Diseases

May 10, 2023 updated by: Zhu Weiming, Jinling Hospital, China

The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study

Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

200

Description

Inclusion Criteria:

  • patients with stricturing Crohn's diseases
  • no surgical indication
  • patients with asymptomatic penetrating diseases
  • written consent acquired

Exclusion Criteria:

  • patients with surgical indication
  • patients with symptomatic penetrating diseases
  • contraindication of biologics
  • anticipating other trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with stricturing Crohn's diseases
Other: treat these patients with biologics
treat these patients with biologics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical remission rate at 1 year
Time Frame: clinical remission rate at 1 year
clinical remission rate at 1 year (CDAI less than 150)
clinical remission rate at 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical remission rate at 5 year
Time Frame: clinical remission rate at 5 year
clinical remission rate at 5 year (CDAI less than 150)
clinical remission rate at 5 year
surgical recurrence rate at 1 and 5 year
Time Frame: at 1 and 5 year
surgical recurrence : needing surgery for CD recurrence
at 1 and 5 year
endoscopic recurrence rate at 1 and 5 year
Time Frame: at 1 and 5 year
endoscopic recurrence: rutgeerts over i2b
at 1 and 5 year
quality of life of patients assessed by IBDQ
Time Frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
IBDQ
at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
quality of life of patients assessed by Short form 12
Time Frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
Short form 12
at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
score of obstructive
Time Frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
range 0-6, higher means severe
at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Weiming wm Zhu, Ph.D., Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2029

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JinlingH20221203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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