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

NCT01237262 | Unknown Phase 4 DMC

• 1 other identifier: ELIDACE in PSO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TNF alfa inhibitors

ACTIVE COMPARATOR

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.

Drug: Adalimumab, etanercept, infliximab

Interventions

Adalimumab, etanercept, infliximab DRUG

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.

TNF alfa inhibitors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Have no history of latent or active TB prior to screening;
• Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Stefano Piaserico

Padua, Italy, 35122, Italy

Location

Related Publications (2)

• 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.

  PMID: 19641206 BACKGROUND

• 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.

  PMID: 17489975 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; Etanercept; Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• ANDREA PESERICO, PROF

  University of Padova

  STUDY CHAIR

Central Study Contacts

STEFANO PIASERICO, MD

CONTACT

0498212901; andrea.peserico@unipd.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2010
• Last Updated: November 9, 2010

Record last verified: 2010-11

Locations

IT (1)