An Open-Label Multicentre Long-Term Extension Study of Et... | NCT00444340

Studies
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

NCT00444340

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 7, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Ankylosing Spondylitis

Interventions

Enbrel (Etanercept)

Countries

Not provided

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

Dec 2007

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

Apr 2004

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 6, 2007

First Posted Date

Mar 7, 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

Dec 5, 2007

Last Update Posted Date

Dec 7, 2007Estimated

Description Module

Brief Summary

This study is an extension trial of 0881A3-312-EU and is designed to provide information on the safety and efficacy of etanercept in patients with ankylosing spondylitis for up to 3 additional years.

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

Name	Type	Description	Arm Group Labels	Other Names
Enbrel (Etanercept)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.

Secondary Outcomes

Measure	Description	Time Frame
To assess the long-term clinical efficacy of etanercept in these study subjects.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed study 0881A3-312-EU
Agreeable to utilize medically acceptable form of contraception
Able to reconstitute and self-inject or have a designee

Exclusion Criteria:

Withdrawn from study 0881A3-312-EU
Abnormal hematology or chemistry profiles
Clinically relevant medical conditions including: congestive heart failure, multiple sclerosis or other central demyelinating diseases, blood dyscrasias, cancer or serious infection

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

Not provided

Sampling Method

Not provided

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

Not provided

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