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

Last updated on November 15, 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.
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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Descriptive Information
Brief Title  ICMJE Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Official Title  ICMJE Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS
Brief SummaryStudy 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
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE Drug: etanercept
etanercept 50 mg/week
Other Name: Enbrel
Study Arms  ICMJE Experimental: 1
etanercept 50 mg/week
Intervention: Drug: etanercept
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 7, 2012)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2009)
80
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion DateOctober 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00910273
Other Study ID Numbers  ICMJE 0881A3-4458
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Lincoln Medical and Mental Health Center
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2015

ICMJE     Data element required by the

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

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