Clinical trial NCT01237262: Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After TNF Alfa Inhibitors Therapy
Official title: Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After Adalimumab Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Moderate to Severe Psoriasis.
Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern.
Keywords: psoriasis
immune infiltrate
dendritic cells
cytokine expression
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects \> 18 years of age, affected by moderate to severe psoriasis
* Subject has had clinical diagnosis of psoriasis for at least 12 months, stable plaque psoriasis for at least 2 months before screening (subjects with concurrent psoriatic arthritis may be enrolled).
* Subject is naıve to TNF-antagonist therapy and efalizumab.
* Subjects are considered eligible according to the following tuberculosis screening criteria:

  1. Have no history of latent or active TB prior to screening;
  2. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
  3. Within 1 month prior to the first administration of study medication, have negative diagnostic tuberculin skin test.
* Normal chest X-ray within 3 months prior to screening with no evidence of malignancy, infection, current or old TB.
* Subjects' screening and baseline clinical data must be within the normal limit, including the results of medical history, physical examination and laboratory evaluation (complete blood count, serum values for liver enzymes, bilirubin, glucose, albumin, creatinine and urine analysis).
* Willing and able to comply with the protocol requirements for the duration of the study.
* Women of childbearing potential must be using adequate birth control measure throughout the study and for 150 days (5 months) after study completion.

Exclusion Criteria:

* Pregnant or breast-feeding women, or women who are planning pregnancy.
* Patients not suitable for TNF alfa inhibitors therapy

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Stefano Piaserico
Study officials:
affiliation: University of Padova
name: ANDREA PESERICO, PROF
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.