An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
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To assess the long-term safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who participated in the core CAIN457A2202 phase II proof-of-concept study. [ Time Frame: 60 weeks ]
Secondary Outcome Measures :
To assess the long term immunogenicity of AIN457 [ Time Frame: 60 weeks ]
To assess the long term concentration of IL-17 in blood [ Time Frame: 60 weeks ]
To assess markers of disease activity CRP, calprotectin and lactoferrin in the long term [ Time Frame: 60 weeks ]
To assess the pharmacokinetics of AIN457 at steady-state [ Time Frame: 60 weeks ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
Patients who were non-compliant or who demonstrated a mahor protocol violation in the core CAIN457A2202 study
Patients who discontinued from the core CAIN457A2202 study before end of study.
Other protocol-defined inclusion/exclusion criteria may apply