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

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ClinicalTrials.gov Identifier: NCT00224562

Recruitment Status : Unknown

Verified February 2004 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Recruiting

First Posted : September 23, 2005

Last Update Posted : October 26, 2005

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

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
Rheumatoid Arthritis Crohn's Disease Ankylosing Spondylitis Psoriasis	Drug: TNF-alpha antagonists

Study Design

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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 :	February 2004

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis Ankylosing spondylitis Crohn disease

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Spondylarthropathy

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224562

Contacts

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Contact: Florence TUBACH, MD	01 40 25 62 51	florence.tubach@bch.aphp.fr

Locations

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France
All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine	Recruiting
All Cities, France
Contact: Florence Tubach, MD 01 40 25 62 51 florence.tubach@bch.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lanternier F, Tubach F, Ravaud P, Salmon D, Dellamonica P, Bretagne S, Couret M, Bouvard B, Debandt M, Gueit I, Gendre JP, Leone J, Nicolas N, Che D, Mariette X, Lortholary O; Research Axed on Tolerance of Biotherapies Group. Incidence and risk factors of Legionella pneumophila pneumonia during anti-tumor necrosis factor therapy: a prospective French study. Chest. 2013 Sep;144(3):990-998. doi: 10.1378/chest.12-2820.

Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Bréban M, Pallot-Prades B, Pouplin S, Sacchi A, Chichemanian RM, Bretagne S, Emilie D, Lemann M, Lortholary O, Mariette X; Research Axed on Tolerance of Biotherapies Group. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry. Arthritis Rheum. 2009 Jul;60(7):1884-94. doi: 10.1002/art.24632. Erratum in: Arthritis Rheum. 2009 Aug;60(8):2540. Lorthololary, O [corrected to Lortholary, O].

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ClinicalTrials.gov Identifier:	NCT00224562
Other Study ID Numbers:	1 INSERM
First Posted:	September 23, 2005 Key Record Dates
Last Update Posted:	October 26, 2005
Last Verified:	February 2004

Keywords provided by Assistance Publique - Hôpitaux de Paris:


TNF alpha antagonists infections lymphoma safety

Additional relevant MeSH terms:

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Infection Spondylitis Lymphoma Spondylitis, Ankylosing Crohn Disease Psoriasis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Arthritis Joint Diseases	Musculoskeletal Diseases Skin Diseases, Papulosquamous Skin Diseases Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Bone Diseases, Infectious Bone Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis

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