Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Experimental (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Wyeth
Overall contact:
Pfizer CT.gov Call Center 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
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
Clinical Details
Official title: Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: To evaluate the effects of etanercept on endothelial function and IMT in patients with AS at 12 weeks.
Secondary outcome: 1. To evaluate sustained effect of etanercept on endothelial function and IMT in patients with AS at 52 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion:
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:
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.
Locations and Contacts
Pfizer CT.gov Call Center 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
Alessandria 15100, Italy; Recruiting
Bologna 40138, Italy; Recruiting
Foggia 71100, Italy; Recruiting
Milano 20122, Italy; Recruiting
Palermo 90134, Italy; Recruiting
Potenza 85100, Italy; Recruiting
Prato 59100, Italy; Recruiting
Reggio Emilia 42100, Italy; Recruiting
Roma 00161, Italy; Recruiting
Roma 00128, Italy; Recruiting
Sassari 07100, Italy; Recruiting
Additional Information
Starting date: July 2009
Last updated: March 26, 2010
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