Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00960713 |
Date of registration:
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16/07/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
RITAI |
Scientific title:
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The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders |
Date of first enrolment:
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June 2009 |
Target sample size:
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35 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00960713 |
Study type:
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Observational |
Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Laurent Sailler |
Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age over 18 years
- rituximab is prescribed off-label for an auto-immune disorder
- rituximab prescription is validated by an institutional board
- Patients have given their informed consent to be included in the cohort
Exclusion Criteria:
- Follow-up for 6 months presumably doubtful
- Rituximab is prescribed for rheumatoïd arthritis
- Rituximab is prescribed for lymphoma
- Pregnant or breath feeding women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Auto-immune Thrombocytopenic Purpura
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Cold Agglutinin Disease
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Cryoglobulinemia
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Hemolytic Auto-immune Anaemia
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Pemphigus
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Intervention(s)
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Drug: Rituximab (MABTHERA® or RITUXAN®).
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Primary Outcome(s)
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Occurrence of a serious adverse events
[Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18]
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Secondary Outcome(s)
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Type, severity and frequency of all other adverse events occurring in the year following rituximab
[Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18]
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Factors that may influence the occurrence of infectious adverse events
[Time Frame: Day 14, Week 6, Month 6, Month 12 and Month 18]
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Secondary ID(s)
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0816002
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AOL 2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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