Moderate Psoriasi of degree-severe
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-
Sponsors
AZIENDA OSPEDALIERA FONDAZIONE MACCHI (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): effectiveness of Etanercept in the decreasing of the inflammatory marker in the serum and periumbilical fatty tissue | — |
Countries
Italy
Outcome results
None listed