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

NCT ID: NCT00224562

Last Updated: 2005-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2004-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Crohn's Disease Ankylosing Spondylitis Psoriasis

Keywords

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TNF alpha antagonists infections lymphoma safety

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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TNF-alpha antagonists

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* past or current treatement with TNF-a antagonists
* either lymphoma severe bacterial infection opportunistic infection


* 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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Principal Investigators

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Xavier Mariette, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Dominique Salmon, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Marc Lemann, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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All French departments of rheumatology, internal medicine, gastro-enterology, dermatology, infectious diseases, intensive care unit, oncology and haematology, paediatrics and chest medicine

All Cities, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Florence TUBACH, MD

Role: CONTACT

Phone: 01 40 25 62 51

Email: [email protected]

Facility Contacts

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Florence Tubach, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23744173 (View on PubMed)

Tubach F, Salmon D, Ravaud P, Allanore Y, Goupille P, Breban 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.

Reference Type DERIVED
PMID: 19565495 (View on PubMed)

Other Identifiers

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INSERM

Identifier Type: -

Identifier Source: secondary_id

1

Identifier Type: -

Identifier Source: org_study_id