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

NCT ID: NCT00440817

Last Updated: 2014-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with lymphoma

Lymphoma Occurring in Patients with Rheumatoid Arthritis or Crohn's Disease

No intervention

Intervention Type OTHER

All treatments are prescribed by a physician on the basis of usual clinical practice.

Interventions

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No intervention

All treatments are prescribed by a physician on the basis of usual clinical practice.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Centocor Ortho Biotech Services, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Centocor Ortho Biotech Services, L.L.C.

Locations

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Highland Park, Illinois, United States

Site Status

Wichita, Kansas, United States

Site Status

Albany, New York, United States

Site Status

Countries

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United States

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=131&filename=CR011239_CSR.pdf

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

Other Identifiers

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C0168T68

Identifier Type: OTHER

Identifier Source: secondary_id

CR011239

Identifier Type: -

Identifier Source: org_study_id

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