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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Inflammatory Bowel Disease; Crohn's Disease

Treatments: Drug: AIN457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009281

EudraCT number: 2009-011621-14

CAIN457A2202E1

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

AIN457

Experimental group

Treatment:

Drug: AIN457