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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00224562
Date of registration: 14/09/2005
Prospective Registration: No
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists
Scientific title: The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists
Date of first enrolment: February 2004
Target sample size:
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00224562
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Longitudinal  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Xavier Mariette, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Name:     Florence Tubach, MD
Address: 
Telephone: 01 40 25 62 51
Email: florence.tubach@bch.aphp.fr
Affiliation: 
Name:     Florence TUBACH, MD
Address: 
Telephone: 01 40 25 62 51
Email: florence.tubach@bch.aphp.fr
Affiliation: 
Name:     Dominique Salmon, MD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Name:     Marc Lemann, MD
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique - Hôpitaux de Paris
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ankylosing Spondylitis
Rheumatoid Arthritis
Psoriasis
Intervention(s)
Drug: TNF-alpha antagonists
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
1
INSERM
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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