Stopping Biological Therapy in PCD Study

January 13, 2022 updated by: Mak Wing Yan, Chinese University of Hong Kong

Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study

The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This clinical trial in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.

The primary endpoint is clinical relapse at 12 months.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. At least 18 years old 2. Have a confirmed diagnosis of perianal Crohn's disease according to established clinical, endoscopic, radiological and histologic criteria 3. On biological therapy (anti-tumour necrosis factor, anti-integrin, anti-IL12/23) for at least 6 months 4. Confirmation of radiologically healed perianal Crohn's fistulas on MRI pelvis within the past 12 months by experienced radiologists 5. In steroid-free clinical remission for at least 6 months with fecal calprotectin <250 μg/g 6. Stable doses of immunosuppressants for at least 3 months if immunosuppressants are used 7. Written informed consent

Exclusion Criteria:

  • 1. History of severe acute or delayed infusion reaction to biological therapy 2. Fistulising Crohn's disease to organs other than perianal Crohn's fistula (fistulation to skin, intestines, bladder etc.) 3. Prior history of diverting ileostomy, colostomy, proctocolectomy or proctectomy 4. Known pregnancy 5. Terminal illness

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perianal Crohn's patient
Stopping biological therapy
Other: Stopping biological therapy
Stopping biological therapy The primary endpoint is clinical relapse at 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of perianal Crohn's disease relapse within 12 months after stopping
Time Frame: 12 months
Relapse rate of patient will be calculated
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy
Time Frame: 12 months
Relapse rate of patient will be calculated
12 months
Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse
Time Frame: 12 months
Relapse rate of patient will be calculated
12 months
Factors associated with relapse of perianal Crohn's disease after stopping biological therapy
Time Frame: 12 months
Factors associated factors will be measured by questionnaire and clinical assessment
12 months
Factors associated with relapse of luminal Crohn's disease after stopping biological therapy
Time Frame: 12 months
Factors associated factors will be measured by questionnaire and clinical assessment
12 months

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Wing Yan Mak, MRCP, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP-PCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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