An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohn's Disease.
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.
|Study Design:||Time Perspective: Retrospective|
|Official Title:||A Review of Reports of Lymphoma Occurring in Patients With Rheumatoid Arthritis or Crohn's Disease in Centocor-Sponsored and Centocor-Supported Disease Registries|
- Occurrence of lymphoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries
- Assessment of lymphoma risk [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]To evaluate all available data on tissue samples of individual lymphoma cases for the potential association of EBV with the lymphoma.
|Study Start Date:||February 2006|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Patients with lymphoma
Lymphoma Occurring in Patients with Rheumatoid Arthritis or Crohn's Disease
Other: No intervention
All treatments are prescribed by a physician on the basis of usual clinical practice.
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.
|United States, Illinois|
|Highland Park, Illinois, United States|
|United States, Kansas|
|Wichita, Kansas, United States|
|United States, New York|
|Albany, New York, United States|
|Study Director:||Centocor Ortho Biotech Services, L.L.C. Clinical Trial||Centocor Ortho Biotech Services, L.L.C.|