A Long-term Safety Study of Infliximab (Remicade)

Study Overview
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Brief Summary
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This is a study evaluating the long-term safety of infliximab (Remicade)

Detailed Description
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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.

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

Conditions
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Arthritis, Rheumatoid, Crohn Disease, Psoriasis

Intervention / Treatment
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* Drug: Infliximab (Remicade)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients in infliximab clinical studies<br>All patients enrolled in selected Centocor sponsored infliximab clinical studies. | Drug: Infliximab (Remicade)<br>* This is an non-interventional study. Participants took the study product as part of their medical routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with each of the following long-term safety events | 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. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with malignancies by malignancy type | Number of patients with malignancies by malignancy type (ie, lymphoma, nonmelanoma skin cancers, other malignancies). | Five years | 
| Number of patients with serious infections by type of infection |  | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Crohn's disease, Psoriasis