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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:
NCT00440817
First received: February 26, 2007
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Lymphoma
Other: No intervention
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Centocor Ortho Biotech Services, L.L.C.:

Primary Outcome Measures:
  • Occurrence of lymphoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To examine the occurrence of lymphoma among patients in one Centocor-sponsored and Centocor-supported disease registries


Secondary Outcome Measures:
  • Assessment of lymphoma risk [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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

  • Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To evaluate all available data on tissue samples of individual lymphoma cases for the potential association of EBV with the lymphoma.


Enrollment: 120
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440817

Locations
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
Study Director: Centocor Ortho Biotech Services, L.L.C. Clinical Trial Centocor Ortho Biotech Services, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier: NCT00440817     History of Changes
Other Study ID Numbers: CR011239, C0168T68
Study First Received: February 26, 2007
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor Ortho Biotech Services, L.L.C.:
Lymphoma
Rheumatoid arthritis
Crohn's disease
Remicade
Infliximab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Crohn Disease
Lymphoma
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on April 17, 2014