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

NCT00910273 | Terminated Phase 4 Results

• 1 other identifier: 0881A3-4458
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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

Conditions

Ankylosing Spondylitis

Keywords

IMT evaluation in AS patients treated with etanercept

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12

  Brachial artery (BA) FMD equals (=)(maximum diameter minus\[-\] baseline diameter divided by baseline diameter) times (\*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.

  Baseline, Week 12

Secondary Outcomes (22)

• Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52

  Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)

• Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52

  Baseline, Week 12 and 52 or ET

• Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52

  Baseline, Weeks 4, 12, 24, 36 and 52 or ET

• Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52

  Baseline, Weeks 4, 12, 24, 36 and 52 or ET

• Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52

  Baseline, Weeks 4, 12, 24, 36 and 52 or ET

Study Arms (1)

1

EXPERIMENTAL

etanercept 50 mg/week

Drug: etanercept

Interventions

etanercept DRUG

etanercept 50 mg/week

Also known as: Enbrel

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Pfizer: lead
• Lincoln Medical and Mental Health Center: collaborator

Study Sites (4)

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Prato, 59100, Italy

Location

Pfizer Investigational Site

Reggio Emilia, 42100, Italy

Location

Pfizer Investigational Site

Roma, 00161, Italy

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Due to early termination and few participants attending visits after Week 12, statistical analysis limited to Week 12.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 29, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 13, 2016
• Results First Posted: January 13, 2016

Record last verified: 2015-12

Locations

IT (4)