Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients (CREST)
This study has been terminated.
Sponsor:
Pfizer
Collaborator:
Lincoln - CRO
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00910273
First received: May 27, 2009
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: etanercept |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To evaluate the effects of etanercept on endothelial function and IMT in patients with AS at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 1. To evaluate sustained effect of etanercept on endothelial function and IMT in patients with AS at 52 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 34 |
| Study Start Date: | July 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
etanercept 50 mg/week
|
Drug: etanercept
etanercept 50 mg/week
Other Name: Enbrel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, see Attachment 4) >= 4 at screening visit.
- Patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks
- 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.
- Ability to self-inject drug or have a designee who can do so.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910273
Locations
| Italy | |
| Pfizer Investigational Site | |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | |
| Prato, Italy, 59100 | |
| Pfizer Investigational Site | |
| Reggio Emilia, Italy, 42100 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00161 | |
Sponsors and Collaborators
Pfizer
Lincoln - CRO
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00910273 History of Changes |
| Other Study ID Numbers: | 0881A3-4458 |
| Study First Received: | May 27, 2009 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Pfizer:
|
IMT evaluation in AS patients treated with etanercept |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013