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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00910273
• Date of registration: 27/05/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients CREST
• Scientific title: Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS
• Date of first enrolment: July 2009
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00910273
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Italy

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: etanercept

Primary Outcome(s)

Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36, and 52 or ET]

Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52 [Time Frame: 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 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52 [Time Frame: Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET)]

Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52 [Time Frame: Week 4, 12, 24, 36, and 52 or ET]

Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36, and 52 or ET]

Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36, 52 or ET]

Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36 and 52 or ET]

Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52 [Time Frame: Baseline, Week 12 and 52 or ET]

Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 4, 12, 24, 36 and 52 or ET]

Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36, and 52 or ET]

Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36 and 52 or ET]

Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36 and 52 or ET]

Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52 [Time Frame: Weeks 4, 12, 24, 36 and 52 or ET]

Secondary ID(s)

0881A3-4458

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lincoln Medical and Mental Health Center

Results

• Results available: Yes
• Date Posted: 13/01/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00910273