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Infliximab and Methotrexate in Ankylosing Spondylitis (SPAXIM)

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
infliximab
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

Exclusion Criteria:

  • Contra-indications to anti-TNF drugs

Sites / Locations

  • University Hospital Jean MINJOZ -Besançon
  • University hospital of Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infliximab

Infliximab +methotrexate

Arm Description

Infliximab

Infliximab +methotrexate

Outcomes

Primary Outcome Measures

Pharmacokinetic properties of infliximab in AS patients with or without methotrexate

Secondary Outcome Measures

Individual pharmacokinetic modelisation of infliximab

Full Information

First Posted
July 24, 2007
Last Updated
January 13, 2017
Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT00507403
Brief Title
Infliximab and Methotrexate in Ankylosing Spondylitis
Acronym
SPAXIM
Official Title
Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infliximab
Arm Type
Active Comparator
Arm Description
Infliximab
Arm Title
Infliximab +methotrexate
Arm Type
Experimental
Arm Description
Infliximab +methotrexate
Intervention Type
Drug
Intervention Name(s)
infliximab
Primary Outcome Measure Information:
Title
Pharmacokinetic properties of infliximab in AS patients with or without methotrexate
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Individual pharmacokinetic modelisation of infliximab
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ankylosing spondylitis Needing anti-TNF drugs Exclusion Criteria: Contra-indications to anti-TNF drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PHILIPPE GOUPILLE, MD
Organizational Affiliation
University hospital of Tours, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Jean MINJOZ -Besançon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
University hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21639907
Citation
Mulleman D, Lauferon 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.
Results Reference
derived

Learn more about this trial

Infliximab and Methotrexate in Ankylosing Spondylitis

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