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

NCT ID: NCT01237262

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

TNF alfa inhibitors

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.

Group Type: ACTIVE_COMPARATOR

Adalimumab, etanercept, infliximab

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

University of Padova

Principal Investigators

ANDREA PESERICO, PROF

Role: STUDY_CHAIR

University of Padova

Locations

Stefano Piaserico

Padua, Italy, Italy

Countries

Italy

Central Contacts

STEFANO PIASERICO, MD

Role: CONTACT

Phone: 0498212901

Email: andrea.peserico@unipd.it

Facility Contacts

Stefano Piaserico, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 19641206 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17489975 (View on PubMed)

Other Identifiers

ELIDACE in PSO

Identifier Type: -

Identifier Source: org_study_id