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

NCT00421980

Last updated date
Study Location
Gent, , 09000, Belgium
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Official Title  ICMJE An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE Drug: Etanercept
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 12, 2007)
84
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00421980
Other Study ID Numbers  ICMJE 0881A3-312
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP