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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444340
Enrollment
70
Registered
2007-03-07
Start date
2004-04-30
Completion date
2007-07-31
Last updated
2007-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Brief 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.

Interventions

DRUGEnbrel (Etanercept)

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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* Withdrawn from study 0881A3-312-EU * Abnormal hematology or chemistry profiles * Clinically relevant medical conditions including: congestive heart failure, multiple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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026