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)
|Study Design:||Time Perspective: Prospective|
|Official Title:||Long Term Safety Follow-up of REMICADE (RESULTS)|
|Study Start Date:||July 2002|
The purpose of this study is to collect long-term safety information on infliximab (Remicade) from subjects who participate in research studies using those drugs. All subjects in these 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. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's 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 patients completed participation in the primary study.