A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

• Conditions: Treatment of perianal fistulas in patients suffering from Crohn's Disease.; MedDRA version: 14.0Level: PTClassification code 10016717Term: FistulaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2010-019973-13-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• At least one draining enterocutaneous perianal fistula
• Diagnosis of Crohn's disease (CD) must have been established for at
least 6 months
• At least one ineffective fistula treatment (but no previously failed anti-
TNFa (tumour necrosis factor) antibody treatment)
• Patients should not suffer from any other health problems that may
jeopardize their participation in the study.
Additional details and inclusion criteria are available in the clinical study
protocol.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Current or recent (within 30 days of enrollment, or 5 half-lives of the
compound, whichever is longer) use of anti-TNFa antibody treatment
• Active Crohn's disease
• Recent or pending abdominal or ano-rectal surgery, particularly
presence of stricture, or abscess, or retention for which surgery might be indicated
• Previously failed anti-TNFa antibody treatment
• Intercurrent bacterial or viral (intestinal) infection (serologically or
microbiologically confirmed)
Additional details and exclusion criteria are available in the clinical study
protocol.

Study & Design

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