Study Investigating Enbrel Treatment for Ankylosing Spond... | NCT00195416

Studies
Study Investigating Enbrel Treatment for Ankylosing Spondylitis

NCT00195416

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Sep 16, 2009Estimated

Enrollment

526Actual

Phase

Not provided

Conditions

Ankylosing Spondylitis

Interventions

Etanercept

Countries

South Korea

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

Sep 2009

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

Jun 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

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

Sep 15, 2009

Last Update Posted Date

Sep 16, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

Unknown adverse reactions, especially serious adverse reactions
Change of the incidences of adverse reactions under the routine drug uses
Factors that may affect the safety of the drug
Factors that may affect the effectiveness of the drug

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

526Actual

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	Etanercept 25mg Injection, 2 times/week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

Patients with known hypersensitivity to Enbrel or any component of the product
Patients with sepsis or risk of sepsis
Patients with active infections including chronic or localized infections such as tuberculosis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic, secondary and tertiary medical centers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Gyunggi-do		463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068800	Etanercept

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided