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Trial record 85 of 299 for:    "Ankylosing spondylitis"

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

Tracking Information
First Submitted Date  ICMJE July 24, 2007
First Posted Date  ICMJE July 26, 2007
Last Update Posted Date January 16, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2007)
Pharmacokinetic properties of infliximab in AS patients with or without methotrexate [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00507403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2007)
Individual pharmacokinetic modelisation of infliximab [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infliximab and Methotrexate in Ankylosing Spondylitis
Official Title  ICMJE Effect of Methotrexate on the Relation Dose-effect of Infliximab in 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE Drug: infliximab
Study Arms  ICMJE
  • Active Comparator: Infliximab
    Infliximab
    Intervention: Drug: infliximab
  • Experimental: Infliximab +methotrexate
    Infliximab +methotrexate
    Intervention: Drug: infliximab
Publications * Mulleman D, Lauféron F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2007)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion Criteria:

  • Contra-indications to anti-TNF drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00507403
Other Study ID Numbers  ICMJE PHRR/04/PG-SPAXIM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: PHILIPPE GOUPILLE, MD University hospital of Tours, France
PRS Account University Hospital, Tours
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP