A Long-term Safety Study of Infliximab (Remicade)

Completed

• Conditions: Arthritis, Rheumatoid; Crohn Disease; Psoriasis
• Interventions: Drug: Infliximab (Remicade)

• Registration Number: NCT00261976
• Lead Sponsor: Centocor, Inc.

Brief 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.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-06
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-15
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2971

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

• Did not previously participate in Centocor sponsored infliximab clinical studies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients in infliximab clinical studies	Infliximab (Remicade)	All patients enrolled in selected Centocor sponsored infliximab clinical studies.

Primary Outcome Measures

Name	Time	Method
Number of patients with each of the following long-term safety events	Five years	Number of patients with each of the following long-term safety events: serious infections, new malignancies, new autoimmune diseases, death, or delayed hypersensitivity (serum sickness-like) reactions.

Secondary Outcome Measures

Name	Time	Method
Number of patients with malignancies by malignancy type	Five years	Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies).
Number of patients with serious infections by type of infection	Five years