E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002556 |
E.1.2 | Term | Ankylosing spondylitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effects of etanercept on endothelial function and IMT in patients with AS at 12weeks |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 laboratorys 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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La fine dello studio e` lultima visita dellultimo soggetto. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |