Clinical trial NCT00910273: Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients
Official title: Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: IMT evaluation in AS patients treated with etanercept
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Lincoln Medical and Mental Health Center
First posted: 2009-05-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52
timeFrame: Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)
measure: Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52
timeFrame: Baseline, Week 12 and 52 or ET
measure: Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36, and 52 or ET
measure: Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52 or ET
measure: Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52
timeFrame: Week 4, 12, 24, 36, and 52 or ET
measure: Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36, and 52 or ET
measure: Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36 and 52 or ET
measure: Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36 and 52 or ET
measure: Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36 and 52 or ET
measure: Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52
timeFrame: Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36, 52 or ET
measure: Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
measure: Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52
timeFrame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Prato
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: