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

Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern. Clinical Trial

— ELIDACE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01237262
• Other study ID #: ELIDACE in PSO
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 8, 2010
• Last updated: November 8, 2010
• Start date: November 2010

Study information

• Verified date: November 2010
• Source: University of Padova
• Contact: STEFANO PIASERICO, MD
• Phone: 0498212901
• Email: andrea.peserico[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 naive 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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern.
• Moderate to Severe Psoriasis.
• Psoriasis

Intervention

Drug:
• Adalimumab, etanercept, infliximab
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.

Locations

Country	Name	City	State
Italy	Stefano Piaserico	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Bedini C, Nasorri F, Girolomoni G, Pità 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. Epub 2007 May 8. — View Citation

Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a 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	No