Infliximab and Methotrexate in Ankylosing Spondylitis

NCT ID: NCT00507403

Last Updated: 2017-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Infliximab

Infliximab

Group Type ACTIVE_COMPARATOR

infliximab

Intervention Type DRUG

Infliximab +methotrexate

Infliximab +methotrexate

Group Type EXPERIMENTAL

infliximab

Intervention Type DRUG

Interventions

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infliximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ankylosing spondylitis
* Needing anti-TNF drugs

Exclusion Criteria

* Contra-indications to anti-TNF drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PHILIPPE GOUPILLE, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Tours, France

Locations

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University Hospital Jean MINJOZ -Besançon

Besançon, , France

Site Status

University hospital of Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 21639907 (View on PubMed)

Other Identifiers

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PHRR/04/PG-SPAXIM

Identifier Type: -

Identifier Source: org_study_id

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