An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohn's Disease.

Completed

• Conditions: Lymphoma
• Interventions: Other: No intervention

• Registration Number: NCT00440817
• Lead Sponsor: Centocor Ortho Biotech Services, L.L.C.

Brief Summary

The purpose of this study is to examine the association with EBV infection, monitor the occurrence of lymphoma and assess lymphoma risk in patients with rheumatoid arthritis and/or Crohns disease and you have taken infliximab.

Detailed Description

This is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred), registry study where data was collected from 3 different registries sponsored or supported by Centocor. Registries are Centocor-sponsored Therapy Resource Evaluation and Assessment Tool (TREAT™) Registry of Crohn's Disease, and in the following two Centocor-supported registries the Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) registry and the Infliximab RA Registry, a subset of the National Database Registry of Rheumatoid Arthritis (NDBRRA) and of the National Databank for Rheumatic Diseases (NDB). A registry is data collection in a real life physician-patient setting. Physicians prescribe medications for rheumatoid arthritis and/or Crohns disease in accordance with their usual clinical practice and then record this information and provide it to Centocor. For this registry study, Centocor collected data from 3 registries to evaluate the risk of getting lymphoma if you have rheumatoid arthritis and/or Crohns disease and you have taken infliximab. Patients who were in one of the 3 registries and had rheumatoid arthritis and/or Crohns disease and did not take infliximab were also evaluated. This registry study does not involve the use of any investigational drugs.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2007-02-26
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with Crohns disease or rheumatoid arthritis who participate in the specified registries will be included in the analysis. For the lymphoma analysis, patients must be recorded as having a lymphoma during their participation in one of these registries

Exclusion Criteria

• Patients who do not have Crohns disease or rheumatoid arthritis and who did not participate in one of the identified registries will be excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with lymphoma	No intervention	Lymphoma Occurring in Patients with Rheumatoid Arthritis or Crohn's Disease

Primary Outcome Measures

Name	Time	Method
Occurrence of lymphoma	5 years	To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries

Secondary Outcome Measures

Name	Time	Method
Assessment of lymphoma risk	5 years	To assess lymphoma risk in relevant registry patient populations, including patients not receiving anti-TNF therapies, patients receiving conventional immunosuppressants (including corticosteroids), and patients receiving anti-TNF therapies
Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma	5 years	To evaluate all available data on tissue samples of individual lymphoma cases for the potential association of EBV with the lymphoma.