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Infliximab and Methotrexate in Ankylosing Spondylitis (SPAXIM)

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ClinicalTrials.gov Identifier: NCT00507403
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: infliximab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
Active Comparator: Infliximab
Infliximab
Drug: infliximab
Experimental: Infliximab +methotrexate
Infliximab +methotrexate
Drug: infliximab



Primary Outcome Measures :
  1. Pharmacokinetic properties of infliximab in AS patients with or without methotrexate [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Individual pharmacokinetic modelisation of infliximab [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion Criteria:

  • Contra-indications to anti-TNF drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507403


Locations
France
University Hospital Jean MINJOZ -Besançon
Besancon, France, 25030
University hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: PHILIPPE GOUPILLE, MD University hospital of Tours, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00507403     History of Changes
Other Study ID Numbers: PHRR/04/PG-SPAXIM
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents