Infliximab and Methotrexate in Ankylosing Spondylitis

Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00507403

Acronym

SPAXIM

Enrollment

Registered

2007-07-26

Start date

2007-10-31

Completion date

2009-12-31

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

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.

Interventions

DRUGinfliximab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Ankylosing spondylitis * Needing anti-TNF drugs

Exclusion criteria

* Contra-indications to anti-TNF drugs

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic properties of infliximab in AS patients with or without methotrexate	16 weeks

Secondary

Measure	Time frame
Individual pharmacokinetic modelisation of infliximab	16 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026