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

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. Identifier: NCT01009281
Recruitment Status : Terminated
First Posted : November 6, 2009
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Crohn's Disease Inflammatory Bowel Disease Drug: AIN457 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: AIN457 Drug: AIN457

Primary Outcome Measures :
  1. 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 :
  1. To assess the long term immunogenicity of AIN457 [ Time Frame: 60 weeks ]
  2. To assess the long term concentration of IL-17 in blood [ Time Frame: 60 weeks ]
  3. To assess markers of disease activity CRP, calprotectin and lactoferrin in the long term [ Time Frame: 60 weeks ]
  4. To assess the pharmacokinetics of AIN457 at steady-state [ Time Frame: 60 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009281

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01009281    
Other Study ID Numbers: CAIN457A2202E1
EudraCT number: 2009-011621-14
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Crohn's Disease
Bowel disease
digestive disorders
auto immune
Inflammatory Bowel Disease (IBD)
gastrointestinal diseases
digestive system diseases
IL 17
anti IL-17
monoclonal antibody
Crohn's Disease (Chron's, CD)
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases