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Trial record 1 of 1 for:    NCT00444340
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An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00444340
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2007
First Posted Date  ICMJE March 7, 2007
Last Update Posted Date December 7, 2007
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2007)
To evaluate the long-term safety of etanercept in adults with ankylosing spondylitis who have completed study 0881A3-312-EU.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2007)
To assess the long-term clinical efficacy of etanercept in these study subjects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis
Official Title  ICMJE An Open-Label Multicentre Long-Term Extension Study of Etanercept in 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE Drug: Enbrel (Etanercept)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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: March 6, 2007)
70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00444340
Other Study ID Numbers  ICMJE 0881A3-101615
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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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