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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00507403 |
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Date of registration:
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24/07/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Infliximab and Methotrexate in Ankylosing Spondylitis
SPAXIM |
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Scientific title:
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Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00507403 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 4
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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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PHILIPPE GOUPILLE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University hospital of Tours, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ankylosing spondylitis
- Needing anti-TNF drugs
Exclusion Criteria:
- Contra-indications to anti-TNF drugs
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: infliximab
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Primary Outcome(s)
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Pharmacokinetic properties of infliximab in AS patients with or without methotrexate
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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Individual pharmacokinetic modelisation of infliximab
[Time Frame: 16 weeks]
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Secondary ID(s)
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PHRR/04/PG-SPAXIM
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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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