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OpenTrials
Completed

NCT Number: NCT00507403

Infliximab and Methotrexate in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Jean MINJOZ -Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion criteria

  • Contra-indications to anti-TNF drugs

Treatment and study plan

Infliximab

Drug

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

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Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: SPAXIM

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2007
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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