A Long-term Safety Study of Infliximab… | Clinical Trial

Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab (Remicade)

Drug

This is an non-interventional study. Participants took the study product as part of their medical routine.

Primary outcomes

Number of patients with each of the following long-term safety events

Time frame: 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 outcomes

Number of patients with malignancies by malignancy type

Time frame: 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

Time frame: Five years

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Collaborators

Centocor BV

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2012
Study completion: 2012
First posted: Dec 6, 2005
Registry last updated: Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed