Dettagli per singolo studio

DEC-NET Serial number FR584

Published online	12/10/2006 11.14.00
Last updated	19/06/2006 16.20.48

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	BACTERIAL INFECTION UNSPECIFIED IN CONDITIONS CLAS
Experimental drug
TNF-alpha antagonists Treatment regimen (dosage and duration) Not specified
Gender	Both
Age (range)	Child-Adult
Eligibility criteria
Inclusion criteria
Inclusion Criteria for cases: Adult or children Past or current treatment with TNF-a antagonists *Patient with:Either opportunistic infection, severe bacterial infection or lymphoma. 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 - Controls should not have developed no opportunistic infection , severe bacterial infection and lymphoma
Exclusion criteria
None
Trial design/methodology
Phase	0
Kind of study
Design	Natural History, Longitudinal, Case Control, Prospective Study
Purpose of study
1.To describe the tuberculosis, opportunistic and severe bacterial infections and lymphoma in the treated patients or having been treated with TNF-alpha antagonists,their natural history and their evolution(Study 1 : National Register). 2.To identify the Risk factors for developing these affections among treated patients or having been treated with anti-TNF alpha antagonist(Study 2 :Case Control study).
Primary outcomes
-Incidence of theses diseases(opportunistics and severe bacterial infections, lynmphoma) -Risk factors for developing these diseases.
Secondary outcomes
-
Summary of study design, objectives, and ongoing research findings
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.