NCT00440817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

April 10, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

February 26, 2007

Last Update Submit

April 9, 2014

Conditions

Lymphoma

Keywords

LymphomaRheumatoid arthritisCrohn's diseaseRemicadeInfliximab

Outcome Measures

Primary Outcomes (1)

  • Occurrence of lymphoma

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

    5 years

Secondary Outcomes (2)

  • Assessment of lymphoma risk

    5 years

  • Evaluation of association of Epstein-Barr Virus (EBV) with the lymphoma

    5 years

Study Arms (1)

Patients with lymphoma

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

Other: No intervention

Interventions

No interventionOTHER

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

Patients with lymphoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Highland Park, Illinois, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

Albany, New York, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaArthritis, RheumatoidCrohn Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

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

    Centocor Ortho Biotech Services, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

February 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 10, 2014

Record last verified: 2014-04

Locations

US(3)