Back to resultsAn Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enbrel (Etanercept)
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility 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- Withdrawn from study 0881A3-312-EU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
Sites / Locations
Outcomes
Primary Outcome Measures
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary Outcome Measures
To assess the long-term clinical efficacy of etanercept in these study subjects.
Full Information
NCT ID
NCT00444340
First Posted
March 5, 2007
Last Updated
December 5, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00444340
Brief Title
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Official Title
An Open-Label Multicentre Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Enbrel (Etanercept)
Primary Outcome Measure Information:
Title
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Secondary Outcome Measure Information:
Title
To assess the long-term clinical efficacy of etanercept in these study subjects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
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