NCT00507403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2007

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

July 24, 2007

Last Update Submit

January 13, 2017

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic properties of infliximab in AS patients with or without methotrexate

    16 weeks

Secondary Outcomes (1)

  • Individual pharmacokinetic modelisation of infliximab

    16 weeks

Study Arms (2)

Infliximab

ACTIVE COMPARATOR

Infliximab

Drug: infliximab

Infliximab +methotrexate

EXPERIMENTAL

Infliximab +methotrexate

Drug: infliximab

Interventions

infliximabDRUG
InfliximabInfliximab +methotrexate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ankylosing spondylitis
  • Needing anti-TNF drugs

You may not qualify if:

  • Contra-indications to anti-TNF drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Jean MINJOZ -Besançon

Besançon, 25030, France

Location

University hospital of Tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 21639907DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • PHILIPPE GOUPILLE, MD

    University hospital of Tours, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

January 16, 2017

Record last verified: 2017-01

Locations

FR(2)