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

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Withdrawn from study 0881A3-312-EU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

NCT00444340
Pfizer
Completed
An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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 SummaryThis 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 DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot 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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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