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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01009281
First received: November 5, 2009
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Inflammatory Bowel Disease
Drug: AIN457
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the long term immunogenicity of AIN457 [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • To assess the long term concentration of IL-17 in blood [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • To assess markers of disease activity CRP, calprotectin and lactoferrin in the long term [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of AIN457 at steady-state [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: October 2009
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 Drug: AIN457

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009281

Locations
United States, Connecticut
Conneticut Gastroenterology Institute, 39 Brewster Road
Bristol, Connecticut, United States, 06010
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
Mount Sinai, One Gustave L. Levy Place, Box 1118
New York, New York, United States, 10029
United States, North Carolina
UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
Chapel Hill,, North Carolina, United States, 27599-7032
Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01009281     History of Changes
Other Study ID Numbers: CAIN457A2202E1, EudraCT number: 2009-011621-14
Study First Received: November 5, 2009
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
Crohn's Disease
Crohns
Bowel disease
digestive disorders
auto immune
diarrhea
Inflammatory Bowel Disease (IBD)
gastrointestinal diseases
digestive system diseases
Antibody
IL 17
anti IL-17
monoclonal antibody
Crohn's Disease (Chron's, CD)

Additional relevant MeSH terms:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014