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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01009281
Date of registration: 05/11/2009
Prospective Registration: No
Primary sponsor: Novartis Pharmaceuticals
Public title: An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Scientific title: A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease
Date of first enrolment: October 2009
Target sample size: 7
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01009281
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Austria Canada Germany Poland United States
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease
Crohn's Disease
Intervention(s)
Drug: AIN457
Primary Outcome(s)
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(s)
To assess the long term immunogenicity of AIN457 [Time Frame: 60 weeks]
To assess the pharmacokinetics of AIN457 at steady-state [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]
Secondary ID(s)
EudraCT number: 2009-011621-14
CAIN457A2202E1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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