An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

• Status: Terminated
• Trial end date: 2010-08-19
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.

Exclusion Criteria:

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.

• Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study

• Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).

Other protocol-defined inclusion/exclusion criteria may apply