E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate Psoriasi of degree-severe |
|
MedDRA Classification |
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 verify the correlation between the variations of the marker inflammatory in the serum and periumbilical fatty tissue to molecular level in the patients with psoriasis, before and after the treatment with Etanercept. |
|
E.2.2 | Secondary objectives of the trial |
To verify the correlation between the variations of the marker inflammatory in the serum and periumbilical fatty tissue to molecular level in the patients with psoriasis, before and after the treatment with Etanercept. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Age between the 18 and the 70 years to the first visit 2)Psoriasis plaque on a bodily surface 3) patient non responder to the conventional therapies systemic for the psoriasis either that have shown important collateral effects later on to the administration of such medicines or that present clinical conditions incompatible with the same 4. Resulted negative for the β-HCG in the cautious test of pregnancy for all the women, to exception of those sterile revenues surgically or from at least a year in post menopause 5. Men and women, sexually profits, that participate in the study should employ profitable and valid shapes of contraception 6. The subject designated should have convinces it` of to inject itself for subcutaneous road the medicine object of the study 7. The subject have to be in a position of to include and to demonstrate for registered, the approval informed voluntary first dell` beginning of the study |
|
E.4 | Principal exclusion criteria |
1. Case history restoring serious reactions allergic anaphylactic either reaction to the human monoclonal antibodies and or to any other therapy for the psoriasis 2. Positive case history for infections from the uncontrolled course of origin bacterial, viral, fungina, or infections from atypical micobatteri 3. Story of infections opportunistic 4. Patients HIV+ 5. Pregnancy or the nursing 6. Positive case history for the profitable tuberculosis 7. Presence of neoplasie in the last 5 years, included the illnesses linfoproliferative. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
effectiveness of Etanercept in the decreasing of the inflammatory marker in the serum and periumbilical fatty tissue |
|
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 | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |