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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Adalimumab, etanercept, infliximab

About this trial

This is an interventional basic science trial for Moderate to Severe Psoriasis. focused on measuring psoriasis, immune infiltrate, dendritic cells, cytokine expression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stefano Piaserico

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

TNF alfa inhibitors

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01237262

First Posted

November 8, 2010

Last Updated

November 8, 2010

Sponsor

University of Padova

1. Study Identification

Unique Protocol Identification Number

NCT01237262

Brief Title

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

Acronym

ELIDACE

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

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Padova

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TNF alfa inhibitors

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Adalimumab, etanercept, infliximab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

STEFANO PIASERICO, MD

Phone

0498212901

Ext

0039

andrea.peserico@unipd.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ANDREA PESERICO, PROF

Organizational Affiliation

University of Padova

Official's Role

Study Chair

Facility Information:

Facility Name

Stefano Piaserico

City

Padova

ZIP/Postal Code

35122

Country

Italy

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefano Piaserico, MD

Phone

0498212901

Ext

0039

stefano.piaserico@unipd.it

First Name & Middle Initial & Last Name & Degree

Stefano Piaserico, MD

First Name & Middle Initial & Last Name & Degree

Andrea Peserico, PROF

First Name & Middle Initial & Last Name & Degree

Mauro Alaibac, PROF

First Name & Middle Initial & Last Name & Degree

Edoardo Zattra, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19641206

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.

Results Reference

background

PubMed Identifier

17489975

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.

Results Reference

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

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