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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00507403
Other study ID # PHRR/04/PG-SPAXIM
Secondary ID
Status Completed
Phase Phase 4
First received July 24, 2007
Last updated January 13, 2017
Start date October 2007
Est. completion date December 2009

Study information

Verified date January 2017
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Ankylosing spondylitis

- Needing anti-TNF drugs

Exclusion Criteria:

- Contra-indications to anti-TNF drugs

Study Design


Intervention

Drug:
infliximab


Locations

Country Name City State
France University Hospital Jean MINJOZ -Besançon Besancon
France University hospital of Tours Tours

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Tours Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic properties of infliximab in AS patients with or without methotrexate 16 weeks
Secondary Individual pharmacokinetic modelisation of infliximab 16 weeks
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