Back to resultsAn Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
- Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
- Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
- Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
- Sexually active men had to agree to use a medically accepted form of contraception during the study.
- Able to reconstitute and self-inject test article or have a designee who can do so.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
- Able to store injectable test article at 2°C to 8°C.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00421980
First Posted
January 8, 2007
Last Updated
January 12, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00421980
Brief Title
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in 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
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.
Detailed Description
This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.
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 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
84 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etanercept
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
Sexually active men had to agree to use a medically accepted form of contraception during the study.
Able to reconstitute and self-inject test article or have a designee who can do so.
Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
Able to store injectable test article at 2°C to 8°C.
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
Facility Information:
City
Gent
ZIP/Postal Code
09000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
19411393
Citation
Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Salvarani C, Sanmarti R, Sibilia J, Sieper J, Van Den Bosch F, van der Heijde D, van der Linden S, Wajdula J. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol. 2009 Jun;36(6):1256-64. doi: 10.3899/jrheum.081033. Epub 2009 May 1. Erratum In: J Rheumatol. 2010 Oct;37(10):2198.
Results Reference
derived
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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
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