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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 6 July 2020
Main ID:  EUCTR2018-002064-15-NL
Date of registration: 15/04/2019
Prospective Registration: Yes
Primary sponsor: Academic Medical Center
Public title: Patient preference model: treatment of perianal fistulas in Crohn's disease
Scientific title: Treatment of Perianal FIstulas in Crohn’s Disease: Surgical closure vs Anti-TNF - PISA II-trial
Date of first enrolment: 15/04/2019
Target sample size: 140
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002064-15
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: yes
Other trial design description: Patient preference model: indiffent patns randomised and patns with preference treated accordingly
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Sugical closure
Number of treatment arms in the trial: 2
 
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   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 0310205666818
Email: w.a.bemelman@amc.nl
Affiliation:  Academic Medical Center
Name: Willem Bemelman   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: 0310205666818
Email: w.a.bemelman@amc.nl
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 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Perianal fistulas in Crohn's Disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate and solution 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 with closed fistulas (based on the MRI findings) after 18 months.
Primary end point(s): - The proportion of patients with closed fistula (MRI based)
Secondary Objective: The secondary outcomes parameters will be the number of patients that need a re-intervention due to fistula related complications (abscesses, recurrent or new tract formation), 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: 18 months
Secondary Outcome(s)
Secondary end point(s): - The number of closed fistula tracts
- The proportion of patients undergoing surgical re-intervention
- The number of re-interventions
- 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: Reinterventions: 12 months, all other at 18 months
Secondary ID(s)
66176
Source(s) of Monetary Support
Academic Medical Center
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 29/03/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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