Back to resultsStopping Biological Therapy in PCD Study
Primary Purpose
Perianal Crohn Disease, MRI, Biological Therapy
Status
Withdrawn
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Stopping biological therapy
Sponsored by
About this trial
This is an interventional treatment trial for Perianal Crohn Disease focused on measuring pCD
Eligibility Criteria
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
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Perianal Crohn's patient
Arm Description
Stopping biological therapy
Outcomes
Primary Outcome Measures
Rate of perianal Crohn's disease relapse within 12 months after stopping
Relapse rate of patient will be calculated
Secondary Outcome Measures
Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy
Relapse rate of patient will be calculated
Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse
Relapse rate of patient will be calculated
Factors associated with relapse of perianal Crohn's disease after stopping biological therapy
Factors associated factors will be measured by questionnaire and clinical assessment
Factors associated with relapse of luminal Crohn's disease after stopping biological therapy
Factors associated factors will be measured by questionnaire and clinical assessment
Full Information
NCT ID
NCT04129723
First Posted
October 15, 2019
Last Updated
January 13, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04129723
Brief Title
Stopping Biological Therapy in PCD Study
Official Title
Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No suitable case identified
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Crohn Disease, MRI, Biological Therapy
Keywords
pCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Perianal Crohn's patient
Arm Type
Experimental
Arm Description
Stopping biological therapy
Intervention Type
Other
Intervention Name(s)
Stopping biological therapy
Intervention Description
Stopping biological therapy The primary endpoint is clinical relapse at 12 months
Primary Outcome Measure Information:
Title
Rate of perianal Crohn's disease relapse within 12 months after stopping
Description
Relapse rate of patient will be calculated
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy
Description
Relapse rate of patient will be calculated
Time Frame
12 months
Title
Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse
Description
Relapse rate of patient will be calculated
Time Frame
12 months
Title
Factors associated with relapse of perianal Crohn's disease after stopping biological therapy
Description
Factors associated factors will be measured by questionnaire and clinical assessment
Time Frame
12 months
Title
Factors associated with relapse of luminal Crohn's disease after stopping biological therapy
Description
Factors associated factors will be measured by questionnaire and clinical assessment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Yan Mak, MRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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30165543
Citation
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Stopping Biological Therapy in PCD Study
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