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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

Page last updated: October 04, 2010

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