Infliximab and Methotrexate in Ankylosing Spondylitis

Phase 4

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: infliximab

• Registration Number: NCT00507403
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-24
• Study First Submitted QC: 2007-07-24
• Study First Posted: 2007-07-26
• Study Start: 2007-10
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Ankylosing spondylitis
• Needing anti-TNF drugs

Exclusion Criteria

• Contra-indications to anti-TNF drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infliximab	infliximab	Infliximab
Infliximab +methotrexate	infliximab	Infliximab +methotrexate

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic properties of infliximab in AS patients with or without methotrexate	16 weeks

Secondary Outcome Measures

Name	Time	Method
Individual pharmacokinetic modelisation of infliximab	16 weeks

Trial Locations

Locations (2)

University hospital of Tours; 🇫🇷 Tours, France

University Hospital Jean MINJOZ -Besançon; 🇫🇷 Besancon, France