跳至主要内容
临床试验/NCT00440817
NCT00440817已完成不适用

A Review of Reports of Lymphoma Occurring in Patients With Rheumatoid Arthritis or Crohn's Disease in Centocor-Sponsored and Centocor-Supported Disease Registries

Centocor Ortho Biotech Services, L.L.C.0 个研究点目标入组 120 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Occurrence of lymphoma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Occurrence of lymphoma

时间窗: 5 years

To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries

次要结局

  • Assessment of lymphoma risk(5 years)
  • Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma(5 years)

研究者

发起方
Centocor Ortho Biotech Services, L.L.C.
申办方类型
Industry
责任方
Sponsor

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