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

Wyeth is now a wholly owned subsidiary of Pfizer70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ankylosing Spondylitis

Interventions

Enbrel (Etanercept)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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acceptable form of contraception * Able to reconstitute and self-inject or have a designee Exclusion Criteria: * Withdrawn from study 0881A3-312-EU * Abnormal hematology or chemistry profiles * Clinically relevant medical conditions including: congestive heart failure, multiple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

Outcomes

Primary Outcomes

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

Secondary Outcomes

To assess the long-term clinical efficacy of etanercept in these study subjects.

Data from ClinicalTrials.gov

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