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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01009281
First Posted: November 6, 2009
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 5, 2009
November 6, 2009
June 1, 2012
October 2009
August 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01009281 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Crohn's Disease
  • Inflammatory Bowel Disease
Drug: AIN457
Experimental: AIN457
Intervention: Drug: AIN457
Hueber W, Sands BE, Lewitzky S, Vandemeulebroecke M, Reinisch W, Higgins PD, Wehkamp J, Feagan BG, Yao MD, Karczewski M, Karczewski J, Pezous N, Bek S, Bruin G, Mellgard B, Berger C, Londei M, Bertolino AP, Tougas G, Travis SP; Secukinumab in Crohn's Disease Study Group. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012 Dec;61(12):1693-700. doi: 10.1136/gutjnl-2011-301668. Epub 2012 May 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
Not Provided
August 2010   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Austria,   Canada,   Germany,   Poland
 
NCT01009281
CAIN457A2202E1
EudraCT number: 2009-011621-14
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP