Stopping Biological Therapy in PCD Study

Chinese University of Hong Kong

Overview

The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.

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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Perianal Crohn Disease MRI Biological Therapy

Interventions

Stopping biological therapyOTHER

Stopping biological therapy The primary endpoint is clinical relapse at 12 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Rate of perianal Crohn's disease relapse within 12 months after stopping

Relapse rate of patient will be calculated

Time frame: 12 months

Secondary Outcomes

Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy

Relapse rate of patient will be calculated

Time frame: 12 months

Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse

Relapse rate of patient will be calculated

Time frame: 12 months

Factors associated with relapse of perianal Crohn's disease after stopping biological therapy

Factors associated factors will be measured by questionnaire and clinical assessment

Time frame: 12 months

Factors associated with relapse of luminal Crohn's disease after stopping biological therapy

Factors associated factors will be measured by questionnaire and clinical assessment

Time frame: 12 months

Data from ClinicalTrials.gov

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