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NCT00444340 Clinical Trial

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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00444340
Other study ID # 0881A3-101615
Secondary ID
Status Completed
Phase Phase 4
First received March 5, 2007
Last updated December 5, 2007
Start date April 2004
Est. completion date July 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministry of Social Affairs, Public Health and the EnvironmentFinland: Ethics CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Spain: Ministry of HealthUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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- Withdrawn from study 0881A3-312-EU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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Enbrel (Etanercept)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary To assess the long-term clinical efficacy of etanercept in these study subjects.
See also
  Status Clinical Trial Phase
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