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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440817
• Other study ID #: CR011239
• Secondary ID: C0168T68
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2007
• Last updated: April 9, 2014
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2014
• Source: Centocor Ortho Biotech Services, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Crohn Disease
• Lymphoma

Intervention

Other:
• No intervention
All treatments are prescribed by a physician on the basis of usual clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor Ortho Biotech Services, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of lymphoma	To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries	5 years	No
Secondary	Assessment of lymphoma risk	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	5 years	No
Secondary	Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma	To evaluate all available data on tissue samples of individual lymphoma cases for the potential association of EBV with the lymphoma.	5 years	No

External Links

•   A review of reports of lymphoma occuring in patients with rheumatoid arthritis or Crohn's disease in Centocor-sponsored or Centocor-supported disease registries.