Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

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NCT00458185

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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
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.

- BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).

- Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

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


- Complete ankylosis (fusion) of spine.


- Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.


- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with
hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during
this study but doses must be held stable for 4 weeks before baseline examination and
for the duration of the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
Official Title  ICMJE Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis
Brief Summary This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
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: 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
Actual Enrollment  ICMJE
 (submitted: April 5, 2007)		40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
  • BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
  • Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

Exclusion Criteria:

  • Complete ankylosis (fusion) of spine.
  • Previous receipt of etanercept, antibody to TNF?, or other TNF? inhibitors.
  • Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 NCT00458185
Other Study ID Numbers  ICMJE 0881A-101871
Has Data Monitoring Committee No
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 March 2008

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