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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Ankylosing Spondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

etanercept 50 mg/week

Group Type EXPERIMENTAL

etanercept

Intervention Type DRUG

etanercept 50 mg/week

Interventions

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etanercept

etanercept 50 mg/week

Intervention Type DRUG

Other Intervention Names

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Enbrel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No