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

Stopped early · Phase 2

Conditions studied: Crohn's Disease, Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID

NCT01009281

Run by

Novartis Pharmaceuticals

People needed

7

Starts

2009-10-30

Expected to finish

2010-08-19

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study
• Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Conneticut Gastroenterology Institute, 39 Brewster Road — Bristol, Connecticut, United States
• Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
• Mount Sinai, One Gustave L. Levy Place, Box 1118 — New York, New York, United States
• UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road, — Chapel Hill, North Carolina, United States
• Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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