Inflammatory Bowel Disease — Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis
Citation(s)
Brandse J F. MWM, de Bruyn J., Wolbink GJ., Lowenberg M., Ponsioen C., van den Brink G.R., D'Haens G.R. Fecal Loss of Infliximab As a Cause of Lack of Response in Severe Inflammatory Bowel Disease. Gastroenterology May 2013;144:S-36.
Campbell S, Travis S, Jewell D Ciclosporin use in acute ulcerative colitis: a long-term experience. Eur J Gastroenterol Hepatol. 2005 Jan;17(1):79-84.
Danese S, Fiocchi C Ulcerative colitis. N Engl J Med. 2011 Nov 3;365(18):1713-25. doi: 10.1056/NEJMra1102942. Review.
Loftus EV Jr Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology. 2004 May;126(6):1504-17.
Sandborn WJ A critical review of cyclosporine therapy in inflammatory bowel disease. Inflammatory Bowel Diseases 1995;1:48-63.
Waljee A, Waljee J, Morris AM, Higgins PD Threefold increased risk of infertility: a meta-analysis of infertility after ileal pouch anal anastomosis in ulcerative colitis. Gut. 2006 Nov;55(11):1575-80. Epub 2006 Jun 13. Review.
Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
