A randomized clinical trial: treatment of perianal fistulas in Crohn's disease

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-002932-25-NL
• Date of registration: 25/07/2013
• Prospective Registration: Yes
• Primary sponsor: Academic Medical Center
• Public title: A randomized clinical trial: treatment of perianal fistulas in Crohn's disease
• Scientific title: Multimodal treatment of perianal fistulas in Crohn's disease: seton vs anti-TNF vs advancement plasty - PISA-trial
• Date of first enrolment: 21/08/2013
• Target sample size: 126
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002932-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: seton drainage Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Netherlands

Contacts

• Name: Willem Bemelman
• Affiliation: Academic Medical Center

• Name: Willem Bemelman
• Affiliation: Academic Medical Center

Key inclusion & exclusion 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) no
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
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Perianal fistulas in Crohn's Disease

Intervention(s)

Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion

Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)

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).

Primary end point(s): The proportion of patients undergoing surgical re-intervention

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).

Timepoint(s) of evaluation of this end point: 12 months after randomization

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 18 months after randomization

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)

Secondary ID(s)

PISA27062013

Source(s) of Monetary Support

Academic Medical Center

Ethics review

Status: Approved
Approval date:
Contact: