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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Infliximab

Criteria

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-TNFα (tumour necrosis factor) antibody treatment)

• Patients should not suffer from any other health problems that may jeopardize their participation in the study.

Exclusion Criteria:

• Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFα 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-TNFα antibody treatment

• Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)

Other protocol-defined inclusion/exclusion criteria may apply