Status:
TERMINATED
Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Lincoln Medical and Mental Health Center
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients
Eligibility Criteria
Inclusion
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, see Attachment 4) \>= 4 at screening visit.
- Patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks
- Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study.
- Ability to self-inject drug or have a designee who can do so.
- Ability to store injectable test article at 2ºC to 8ºC.
Exclusion
- 1\. Pregnancy confirmed by test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of the test article.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00910273
Start Date
July 1 2009
End Date
October 1 2011
Last Update
January 13 2016
Active Locations (4)
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1
Pfizer Investigational Site
Bologna, Italy, 40138
2
Pfizer Investigational Site
Prato, Italy, 59100
3
Pfizer Investigational Site
Reggio Emilia, Italy, 42100
4
Pfizer Investigational Site
Roma, Italy, 00161