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Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Bologna, , 40138 Italy
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.
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1. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.

2. AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI, see Attachment 4) >= 4 at screening visit.

3. Patients capable, in the opinion of the investigator, of complying with the treatment
schedule and doses throughout the 52 weeks

4. 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.

5. Ability to self-inject drug or have a designee who can do so.

6. Ability to store injectable test article at 2ºC to 8ºC.

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

NCT00910273
Pfizer
Terminated
Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients

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1-800-718-1021

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