Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
NCT00910273
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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.
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.
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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 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 | |||
| Detailed Description | Not 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 | 34 | |||
| Original Estimated Enrollment ICMJE | 80 | |||
| Actual Study Completion Date ICMJE | October 2011 | |||
| Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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 |
| |||
| 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 Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Lincoln Medical and Mental Health Center | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||