Infliximab and Methotrexate in Ankylosing Spondylitis (SPAXIM)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00507403
First received: July 24, 2007
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Ankylosing Spondylitis
Drug: infliximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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

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

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Infliximab
Drug: infliximab

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion Criteria:

  • Contra-indications to anti-TNF drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospital, Tours

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CHRU-TOURS , Direction de la Recherche, University Hospital, Tours
ClinicalTrials.gov Identifier: NCT00507403     History of Changes
Other Study ID Numbers: PHRR/04/PG-SPAXIM
Study First Received: July 24, 2007
Last Updated: February 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014