Patient preference model: treatment of perianal fistulas in Crohn's disease

Phase 1

• Conditions: Perianal fistulas in Crohn's Disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-002064-15-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- = 18 years
-Written informed consent
- High tract (intersphincteric, transsphincteric, suprasphincteric) perianal fistula located in the upper
two-thirds of the external sphincter
-Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not
have to be taken into account
- Both new fistulas or recurrent active fistula (defined as any producing fistula)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum)
- Anorectal stenosis (defined as the impossibility to introduce a proctoscope)
- Submucosal fistulas & low intersphincteric fistulas (lower one-third of external sphincter)
- Rectovaginal fistula
- Multiple internal openings
- Use of Anti-TNF medication for more than 3 months
-Previous Anti-TNF medication without any effect on perianal fistulas
- Previously demonstrated allergy for anti-TNF medication. If this allergy only concerns the chimeric
monoclonal mouse-antibody infliximab, the patient could be randomised for adalumimab
- Patients with a stoma
- Immunocompromised patients with a contra-indication for anti-TNF
-Life expectancy < 2 years
- The inability of reading/understanding and filling in the questionnaires
- Dementia or altered mental status that would prohibit the understanding and giving of informed
consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified