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

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Enbrel (Etanercept)

Intervention Type DRUG

Eligibility Criteria

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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* Withdrawn from study 0881A3-312-EU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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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0881A3-101615

Identifier Type: -

Identifier Source: org_study_id