Biological Therapy, MRI, Perianal Crohn Disease
Conditions
Keywords
pCD
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The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.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disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.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.
Interventions
OTHERStopping biological therapy
Stopping biological therapy The primary endpoint is clinical relapse at 12 months
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of perianal Crohn's disease relapse within 12 months after stopping | 12 months | Relapse rate of patient will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy | 12 months | Relapse rate of patient will be calculated |
| 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 |
| 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 |
Countries
Hong Kong
Outcome results
None listed