Ankylosing Spondylitis MedDRA version: 9.1 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis
Conditions
Interventions
Trade Name: Enbrel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Etanercept
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical fo
Sponsors
WYETH LEDERLE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Age 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-TNFα drugs Administration of statins within 4 week of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of etanercept on endothelial function and IMT in patients with AS at 12weeks;Secondary Objective: 1.To evaluate sustained effect of etanercept on endothelial function and IMT in patients with AS at 52 weeks. 2.To evaluate the effect of etanercept on AS disease activity over 12 and 52 weeks 3.To evaluate the safety of etanercept in AS patients over 12 and 52 weeks;Primary end point(s): The primary endpoint is the mean change in flow-mediated dilatation from baseline to 12 weeks. Primary objective would be the assessment of endothelial function, as per flow mediated dilatation (FMD) in patients with active AS at 12 weeks. Particularly, it would be evaluated any positive variation of FMD in AS patients, after and during etancercept treatment, comparing to placebo controls. | — |
Countries
Italy
Outcome results
None listed