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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Psoriasis; Crohn's Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Drug: TNF-alpha antagonists

Study type: Observational

Funder types: Other

Identifiers

NCT00224562

1

INSERM

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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