An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
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
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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
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 Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013