NCT01237262|UnknownPhase 4DMC
Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After TNF Alfa Inhibitors Therapy
ELIDACE
Loading search results
Sponsor study identifier
interventional
20
1 country
1
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
Not reported
Date not reportedThe 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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 2010
Actual (reported)November 8, 2010
Actual (reported)November 9, 2010
Actual (reported)changes in absolute numbers, density of immunocompetent cells and inflammatory cytokines expression pattern in psoriasic lesions vs normal skin of the same patient, pre and post-TNF alfa inhibitors treatment.
* 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 biologics.
12 months
Male and female adult patients with a diagnosis of moderate to severe psoriasis (when PASI score is \> 10 and BSA is \> 10%). The overall study enrolment plan is 20 patients. Patients will be screened before the beginning of clinical trial by blood sample in order to exclude major contraindications to use of anti TNF α drugs.
Adalimumab at a dose of 80 mg at week 0 (Baseline) and successively 40 mg every other week starting from week1 and up to week 15. Adalimumab will be administered as subcutaneous injection. Etanercept at a dose of 50 mg every week, as subcutaneous injection. Infliximab at a dose of 5 mg/kg at week 0 (Baseline), then at week 2 and every 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Adalimumab, etanercept, infliximab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordStefano Piaserico
Padova, Italy, 35122, Italy
Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
Bedini C, Nasorri F, Girolomoni G, Pita Od, Cavani A. Antitumour necrosis factor-alpha chimeric antibody (infliximab) inhibits activation of skin-homing CD4+ and CD8+ T lymphocytes and impairs dendritic cell function. Br J Dermatol. 2007 Aug;157(2):249-58. doi: 10.1111/j.1365-2133.2007.07945.x. Epub 2007 May 8.
ANDREA PESERICO, PROF
University of Padova
First Submitted
November 8, 2010
First Posted
November 9, 2010
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
November 9, 2010
Record last verified: 2010-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: