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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
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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 related topics: Lymphoma

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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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Infections
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