NCT00936585 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Abdul-Baki H, ElHajj I, El-Zahabi LM, Azar C, Aoun E, Zantout H, Nasreddine W, Ayyach B, Mourad FH, Soweid A, Barada KA, Sharara AI
Clinical epidemiology of inflammatory bowel disease in Lebanon. Inflamm Bowel Dis. 2007 Apr;13(4):475-80.
Baumgart DC, Sandborn WJ
Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. Review.
Best WR, Becktel JM, Singleton JW, Kern F Jr
Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.

NIH SUBSTUDY:Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Assess the Efficacy, Safety and Tolerability of Two Single Infusions of AIN457 in Patients With Moderate to Severe Active Crohn's Disease

Details for clinical trial NCT00936585

Clinical trial NCT00936585 - References