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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by University of Padova.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237262
First Posted: November 9, 2010
Last Update Posted: November 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Padova
  Purpose

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.

Condition Intervention Phase
Moderate to Severe Psoriasis. Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern. Drug: Adalimumab, etanercept, infliximab Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After Adalimumab Therapy

Resource links provided by NLM:


Further study details as provided by University of Padova:

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. [ Time Frame: 12 months ]
    • 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.


Estimated Enrollment: 20
Study Start Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.


  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237262


Contacts
Contact: STEFANO PIASERICO, MD 0498212901 ext 0039 andrea.peserico@unipd.it

Locations
Italy
Stefano Piaserico Not yet recruiting
Padova, Italy, 35122
Contact: Stefano Piaserico, MD    0498212901 ext 0039    stefano.piaserico@unipd.it   
Sub-Investigator: Stefano Piaserico, MD         
Principal Investigator: Andrea Peserico, PROF         
Sub-Investigator: Mauro Alaibac, PROF         
Sub-Investigator: Edoardo Zattra, MD         
Sponsors and Collaborators
University of Padova
Investigators
Study Chair: ANDREA PESERICO, PROF University of Padova
  More Information

Publications:
Responsible Party: ANDREA PESERICO, University of Padova
ClinicalTrials.gov Identifier: NCT01237262     History of Changes
Other Study ID Numbers: ELIDACE in PSO
First Submitted: November 8, 2010
First Posted: November 9, 2010
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by University of Padova:
psoriasis
immune infiltrate
dendritic cells
cytokine expression

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Etanercept
Infliximab
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents