Status:
WITHDRAWN
Stopping Biological Therapy in PCD Study
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Perianal Crohn Disease
MRI
Eligibility:
All Genders
18+ years
Phase:
NA
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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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 clinica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04129723
Start Date
January 1 2022
End Date
December 31 2025
Last Update
January 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong