drugset / Trial / NCT01237262

Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After TNF Alfa Inhibitors Therapy

NCT01237262

Phase 4 Unknown 20 enrolled University of Padova
NaSingle-groupOpen-labelBasic science

Summary

The efficacy of TNF alfa inhibitors in the treatment of psoriasis has been documented in many studies. Their effect on dendritic cells has been scarcely studied. TNF- α has a central role in dendritic cell biology, both for their maturity and mobilization of peripheral tissues to secondary lymphoid organs. The primary objectives of this study are: * To document absolute number, density of immune infiltrate and dendritic cells and inflammatory cytokines expression pattern (particularly IFN α and IL-32) in psoriasic lesions vs normal skin of the same patient * To describe changes in such cell numbers and expression patterns upon 16 weeks treatment with TNF alfa inhibitors.

Timeline

Start
2010-11
Primary completion
2010-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Comparator Infliximab Monoclonal antibody 5 mg/kg

Indications