Infliximab and Methotrexate in Ankylosing Spondylitis | NCT00507403

Studies
Infliximab and Methotrexate in Ankylosing Spondylitis

NCT00507403

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Jan 16, 2017Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Ankylosing Spondylitis

Interventions

infliximab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 24, 2007

First Submission Date that Met QC Criteria

Jul 24, 2007

First Posted Date

Jul 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infliximab	Active Comparator	Infliximab	Drug: infliximab
Infliximab +methotrexate	Experimental	Infliximab +methotrexate	Drug: infliximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
infliximab	Drug		Infliximab Infliximab +methotrexate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic properties of infliximab in AS patients with or without methotrexate		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Individual pharmacokinetic modelisation of infliximab		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ankylosing spondylitis
Needing anti-TNF drugs

Exclusion Criteria:

Contra-indications to anti-TNF drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PHILIPPE GOUPILLE, MD	University hospital of Tours, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Jean MINJOZ -Besançon		Besançon		25030	France
University hospital of Tours

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21639907	Derived	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.

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins