Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-03-08 @ 3:40 AM
Study NCT ID:
NCT00507403
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2007-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infliximab and Methotrexate in Ankylosing Spondylitis
Sponsor:
University Hospital, Tours
Organization:
Study Overview
Official Title:
Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPAXIM
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: