Effects of Etanercept on Endothelial Function and Carotid Intima-Media Thickness In Patients With Active Ankylosing Spondylitis: a 52-Weeks, Randomized, Double Blind, Placebo-Controlled Study - CREST

• Conditions: Ankylosing Spondylitis; MedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis

• Registration Number: EUCTR2007-003096-39-IT
• Lead Sponsor: WYETH LEDERLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients meeting the modified New York criteria for AS with active disease as defined by BASDAI ≥4 at screening visit. Patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks. Signature of an informed consent to enter the study. A negative serum pregnancy test is required at screening for all women except those who were surgically sterile or at least 1 year post menopausal. During the duration of the study contraception is required for all females of childbearing potential. Sexually active men and women participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of test article
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Age <18 years Insulin-dependent diabetes or uncontrolled diabetes mellitus Lactation Total Cholesterol exceeding 240 mg/dl (6 mMol) Homocysteinemia exceeding 15 mmol/l. Abnormality in haematology or chemistry profiles: haemoglobin £ 85 g/L; haematocrit £ 27%; platelet count £ 125 x 109 /L; white blood cell count £ 3.5 x 109 /L; serum creatinine ³ 175 mmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ³ 2 times the laboratory?s upper limit of normal. Serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy) Cancer or history of cancer Myocardial infarction within 12 months of the screening visit Class III or IV congestive heart failure as defined by the New York Heart Association classification (16) or uncompensated congestive heart failure Uncontrolled hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg) Diagnosis of multiple sclerosis or other central demyelinating diseases History of peptic ulcer Previous treatment with anti-TNF&#945; drugs Administration of statins within 4 week of screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified