Stopping Biological Therapy in PCD Study

Not Applicable

Withdrawn

• Conditions: Biological Therapy; Perianal Crohn Disease; MRI
• Interventions: Other: Stopping biological therapy

• Registration Number: NCT04129723
• Lead Sponsor: Chinese University of Hong Kong

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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Status Verified: 2022-01
• Study Start: 2022-01-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perianal Crohn's patient	Stopping biological therapy	Stopping biological therapy

Primary Outcome Measures

Name	Time	Method
Rate of perianal Crohn's disease relapse within 12 months after stopping	12 months	Relapse rate of patient will be calculated

Secondary Outcome Measures

Name	Time	Method
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
Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse	12 months	Relapse rate of patient will be calculated
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
Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy	12 months	Relapse rate of patient will be calculated

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong