A Long-term Safety Study of Infliximab (Remicade)

Centocor Ortho Biotech

Status

Completed

Conditions

Psoriasis

Crohn Disease

Arthritis, Rheumatoid

Treatments

Drug: Infliximab (Remicade)

Study type

Observational

Funder types

Industry

Identifiers

NCT00261976

C0168T45 (Other Identifier)

CR004780

Details and patient eligibility

About

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

Full 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.

Enrollment

2,971 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion criteria