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Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

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NCT00458185

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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 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.

NCT00458185
Pfizer
Completed
Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

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Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis
This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: etanercept
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00458185
0881A-101871
No
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
March 2008

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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