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

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Enbrel (Etanercept) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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.

Clinical Details

Official title: An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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- Withdrawn from study 0881A3-312-EU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

Locations and Contacts

Additional Information

Starting date: April 2004
Ending date: July 2007
Last updated: December 5, 2007

Page last updated: June 20, 2008

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