Perianal fistulas in Crohn's Disease
Conditions
Interventions
Trade Name: REMICADE
Product Name: INFLIXIMAB
Product Code: LO4AB02
Pharmaceutical Form: Powder for concentrate for solution for infusion
Trade Name: HUMIRA
Product Name: ADALIMUMAB
Product Code: L04
Sponsors
ACADEMIC MEDICAL CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
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 116 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 - Seton in situ for more than 3 months - Use of Anti-TNF medication during last 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 (i.e. haematological malignancies, HIV/AIDS, bone marrow transplantation, splenectomy, genetic disorders such as severe combined immunodeficiency, chemotherapy, dialysis, solid organ transplant and long term immunosuppressant use such as corticosteroids in patients with rheumatoid arthritis) - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to analyse the number of patients that need a re-intervention due to fistula-related complications (abscesses, recurrent or new tract formation). E.2.2;Secondary Objective: The secondary outcomes parameters will be the number of patients with closed fistulas (based on MRI findings) after 18 months, Perianal Disease Activity Index (PDAI score) and number of necessary antibiotics courses during fistula treatment, quality of life (EQ-5D and IBDQ), and costs (KEA and BIA);Primary end point(s): The proportion of patients undergoing surgical re-intervention;Timepoint(s) of evaluation of this end point: 12 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The number of re-interventions - The proportion of patients with closed fistulas - The number of closed fistula tracts - The number of necessary antibiotic courses (also not fistula related) - Health related quality of life and costs (EQ-5D and IBDQ) - Disease activity, as measured with the Perianal Disease Activity Index (PDAI) score - Number of sick leave days - Number of in-hospital days - Costs (CEA and BIA);Timepoint(s) of evaluation of this end point: 18 months after randomization | — |
Countries
Belgium, Netherlands
Contacts
Public ContactWILLEM BEMELMAN
ACADEMIC MEDICAL CENTER
Outcome results
None listed