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

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NCT00421980

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Gent, , 09000 Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00421980
Pfizer
Completed
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: Etanercept
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
July 2004
Not Provided
  1. 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.
  2. Negative serum ?-HCG pregnancy test at baseline (all women of childbearing potential).
  3. 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.
  4. Sexually active men had to agree to use a medically accepted form of contraception during the study.
  5. Able to reconstitute and self-inject test article or have a designee who can do so.
  6. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
  7. Able to store injectable test article at 2°C to 8°C.
Sexes Eligible for Study: All
18 Years to 66 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00421980
0881A3-312
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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