A Long-term Safety Study of Infliximab (Remicade)

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261976
• Other study ID #: CR004780
• Secondary ID: C0168T45
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: March 15, 2014
• Start date: February 2002
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2971
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Crohn Disease
• Psoriasis

Intervention

Drug:
• Infliximab (Remicade)
This is an non-interventional study. Participants took the study product as part of their medical routine.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centocor, Inc.	Centocor BV

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Ireland,  Israel,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Number of patients with serious infections by type of infection		Five years	Yes

External Links

•   Study results from the long term safety follow-up of REMICADE (RESULTS)