Clinical trial NCT04129723: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Perianal Crohn Disease
MRI
Biological Therapy
Keywords: pCD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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

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

Primary outcomes:
measure: Rate of perianal Crohn's disease relapse within 12 months after stopping
timeFrame: 12 months
Secondary outcomes:
measure: Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy
timeFrame: 12 months
measure: Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse
timeFrame: 12 months
measure: Factors associated with relapse of perianal Crohn's disease after stopping biological therapy
timeFrame: 12 months
measure: Factors associated with relapse of luminal Crohn's disease after stopping biological therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Wing Yan Mak, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
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