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Clinical Trial Name -The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists
| Original Study ID : 1 |
| Secondary ID : INSERM |
| NCT ID : NCT00224562 |
| Brief Title : The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists |
| Official Title : The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists |
| 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. |
| Source : Assistance Publique - Hôpitaux de Paris |
| Overall Status : Recruiting |
| Start Date : February 2004 |
| Official Title : N/A |
| Phase : Observational |
| Study Design : Natural History, Longitudinal, Case Control, Prospective Study |
| Verification Date : February 2004 |
| First Received Date : September 14, 2005 |
| Trial Eligibility |
| 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 |
| Gender : Both |
| Minimum Age : N/A |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine |
| Status : Recruiting |
| City : all cities |
| Country : France |
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