A Long Term Safety Study of Infliximab (Remicade)
Recruitment status was Active, not recruiting
This is a study evaluating the long-term safety of infliximab (Remicade) in patients with Ulcerative Colitis
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Multicenter International Study of the Long-Term Safety of Infliximab (REMICADE) in Ulcerative Colitis|
|Study Start Date:||June 2004|
This study is to collect long-term safety information on infiximab (Remicade), from subjects who participate in research studies using this drug. The primary studies include C0168T37 and C0168T46. All subjects who had at least one dose of study drug in those studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if patients received infliximab (Remicade) after the end of the primary study. In addition, information will be collected if patients have had any surgery for ulcerative colitis, and to see if patients have had any worsening of ulcerative colitis that required hospitalization since patients studies. Information on colonoscopies will also be collected, for those patients that were considered to have a high risk for dysplasia in the beginning of the original studies and have had a follow-up colonoscopy. Participation in this research study is 5 years after the end of the primary study. Questionnaires about patients health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after completed participation in the primary study.
No drug is provided