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CompletedNCT00507403SPAXIMUpdated Jan 16, 2017

Infliximab and Methotrexate in Ankylosing Spondylitis

A Phase 4 interventional study of infliximab in Ankylosing Spondylitis, sponsored by University Hospital, Tours. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-16.

Sponsored by University Hospital, Tours · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ankylosing Spondylitis
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 30 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion criteria

Exclusion Criteria:

  • Contra-indications to anti-TNF drugs
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Infliximab

    Infliximab

    Drug: infliximab

  • Experimental
    Infliximab +methotrexate

    Infliximab +methotrexate

    Drug: infliximab

Interventions

  • Druginfliximab
06

What researchers measure

Primary outcomes

  1. Pharmacokinetic properties of infliximab in AS patients with or without methotrexate

    Time frame: 16 weeks

Secondary outcomes

  1. Individual pharmacokinetic modelisation of infliximab

    Time frame: 16 weeks

07

Study locations

2 sites
  • University Hospital Jean MINJOZ -Besançon
    Besancon, 25030, France
  • University hospital of Tours
    Tours, 37044, France
08

References and documents

Publications

  • Mulleman D, Lauferon F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350. PubMed 21639907 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00507403
Lead sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jul 26, 2007
Start date
Oct 2007
Primary completion
Oct 2009
Completion
Dec 2009
Last update
Jan 16, 2017

Study contacts

PHILIPPE GOUPILLE, MD
principal investigator · University hospital of Tours, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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