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Stopping Biological Therapy in PCD Study

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04129723
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

Condition or Disease Intervention/Treatment Phase
  • Other: Stopping biological therapy
 N/A

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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of perianal Crohn's disease relapse within 12 months after stopping [12 months]

    Relapse rate of patient will be calculated

Secondary Outcome Measures

  1. Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy [12 months]

    Relapse rate of patient will be calculated

  2. Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse [12 months]

    Relapse rate of patient will be calculated

  3. Factors associated with relapse of perianal Crohn's disease after stopping biological therapy [12 months]

    Factors associated factors will be measured by questionnaire and clinical assessment

  4. Factors associated with relapse of luminal Crohn's disease after stopping biological therapy [12 months]

    Factors associated factors will be measured by questionnaire and clinical assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mak Wing Yan, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04129723
Other Study ID Numbers:
  • STOP-PCD
First Posted:
Oct 17, 2019
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mak Wing Yan, Assistant Professor, Chinese University of Hong Kong
pCD
Additional relevant MeSH terms:
Crohn Disease
Tin Fluorides

Study Results

No Results Posted as of Jan 28, 2022