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

Last updated on May 10, 2018

FOR MORE INFORMATION
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.
Show details

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.
Show details

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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*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  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:

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00910273
0881A3-4458
No
Not Provided
Not Provided
Pfizer
Pfizer
Lincoln Medical and Mental Health Center
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

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

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