Clinical trial NCT00440817: An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohn's Disease.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
Rheumatoid arthritis
Crohn's disease
Remicade
Infliximab
Lead sponsor: Centocor Ortho Biotech Services, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of lymphoma
timeFrame: 5 years
Secondary outcomes:
measure: Assessment of lymphoma risk
timeFrame: 5 years
measure: Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma
timeFrame: 5 years
Other outcomes:
Locations:
city: Highland Park
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Albany
country: United States
state: New York
Study officials:
affiliation: Centocor Ortho Biotech Services, L.L.C.
name: Centocor Ortho Biotech Services, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References: