Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440817
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2007-02-26
Brief Title:
An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohns Disease
Sponsor:
Centocor Ortho Biotech Services LLC
Organization:
Centocor Ortho Biotech Services LLC
Study Overview
Official Title:
A Review of Reports of Lymphoma Occurring in Patients With Rheumatoid Arthritis or Crohns Disease in Centocor-Sponsored and Centocor-Supported Disease Registries
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor Crohns disease and you have taken infliximab
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 Crohns 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 andor 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 andor Crohns disease and you have taken infliximab Patients who were in one of the 3 registries and had rheumatoid arthritis andor Crohns disease and did not take infliximab were also evaluated This registry study does not involve the use of any investigational drugs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C0168T68 | OTHER | Centocor Inc | None |