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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00440817
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.

Study Description
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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.

Condition or disease Intervention/treatment
Lymphoma Other: No intervention

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.
Study Design
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Study Type : Observational
Actual Enrollment : 120 participants
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
Study Start Date : February 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of lymphoma [ Time Frame: 5 years ]
    To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries


Secondary Outcome Measures :
  1. Assessment of lymphoma risk [ Time Frame: 5 years ]
    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

  2. Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma [ Time Frame: 5 years ]
    To evaluate all available data on tissue samples of individual lymphoma cases for the potential association of EBV with the lymphoma.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440817


Locations
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United States, Illinois
Highland Park, Illinois, United States
United States, Kansas
Wichita, Kansas, United States
United States, New York
Albany, New York, United States
Sponsors and Collaborators
Centocor Ortho Biotech Services, L.L.C.
Investigators
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Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
More Information
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Additional Information:

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Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00440817    
Other Study ID Numbers: CR011239
C0168T68 ( Other Identifier: Centocor, Inc. )
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Lymphoma
Rheumatoid arthritis
Crohn's disease
Remicade
Infliximab
Additional relevant MeSH terms:
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Lymphoma
Arthritis
Arthritis, Rheumatoid
Crohn Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases