NCT00261976

A Long-term Safety Study of Infliximab (Remicade)

Long-term Safety Follow-up of REMICADE (RESULTS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,971 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a study evaluating the long-term safety of infliximab (Remicade)

Detailed description

The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients 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 complete participation in the primary study.

Conditions

• Arthritis, Rheumatoid
• Crohn Disease
• Psoriasis

Interventions

Type	Name	Description
DRUG	Infliximab (Remicade)	This is an non-interventional study. Participants took the study product as part of their medical routine.

Timeline

• Start date: 2002-02-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2005-12-06
• Last updated: 2014-03-18

Locations

205 sites across 19 countries: United States, Argentina, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom