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

This study has been terminated.
Sponsor:
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
  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:


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:

  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014