Stopping Biological Therapy in PCD Study

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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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

Official Title
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Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study

Conditions
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Perianal Crohn Disease, MRI, Biological Therapy

Intervention / Treatment
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* Other: Stopping biological therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perianal Crohn's patient<br>Stopping biological therapy | Other: Stopping biological therapy<br>* Stopping biological therapy The primary endpoint is clinical relapse at 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of perianal Crohn's disease relapse within 12 months after stopping | Relapse rate of patient will be calculated | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy | Relapse rate of patient will be calculated | 12 months | 
| Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse | Relapse rate of patient will be calculated | 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 | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pCD