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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Enbrel (Etanercept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444340

0881A3-101615

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Withdrawn from study 0881A3-312-EU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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)