The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Unknown status

CT.gov ID

NCT00224562

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Crohn's Disease Ankylosing Spondylitis Psoriasis	Drug: TNF-alpha antagonists

Study Design

Study Type:

Observational

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Study Start Date :

Feb 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for cases:

past or current treatement with TNF-a antagonists
either lymphoma severe bacterial infection opportunistic infection

Inclusion Criteria for controls:

matched with cases by gender, age (+/- 5 years), underlying disease (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, or psoriasis)
past or current treatement with TNF-a antagonists
no lymphoma, severe bacterial infection, opportunistic infection (same as case)

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine	All Cities		France

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Xavier Mariette, MD PhD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Dominique Salmon, MD, Assistance Publique - Hôpitaux de Paris
Principal Investigator: Marc Lemann, MD, Assistance Publique - Hôpitaux de Paris