Moderate to Severe Psoriasis.Phase 4ELIDACENCT01237262
Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After TNF Alfa Inhibitors Therapy
A Phase 4 study testing Adalimumab, etanercept, infliximab in people with Moderate to Severe Psoriasis. and Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern., run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate to Severe Psoriasis., Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern.
- What is being tested?
- Adalimumab, etanercept, infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Pregnant or breast-feeding women, or women who are planning pregnancy.
- Patients not suitable for TNF alfa inhibitors therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Stefano Piaserico
Padova, Italy, 35122
Stefano Piaserico, MD, 0498212901 ext. 0039, stefano.piaserico@unipd.it
Stefano Piaserico, MD
About this study
Official title: Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After Adalimumab Therapy
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.
- Being tested
- Adalimumab, etanercept, infliximab
- Keywords
- psoriasis, immune infiltrate, dendritic cells, cytokine expression
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab, etanercept, infliximabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Adalimumab, etanercept, infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe Psoriasis.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Investigators
- ANDREA PESERICO, PROF, Study chair, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237262
- Sponsor's protocol ID
- ELIDACE in PSO
- Acronym
- ELIDACE
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19641206Bedini 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.
PubMed 17489975
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lymphocytic Infiltrate, Dendritic Cells and Cytokines Expression in Psoriatic Lesion and Normal Skin Before and After Adalimumab Therapy
- ClinicalTrials.gov ID
- NCT01237262
- Acronym / sponsor ID
- ELIDACE / ELIDACE in PSO
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNF alfa inhibitors | Active comparator | Drug: Adalimumab, etanercept, infliximabMale 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Normal chest X-ray within 3 months prior to screening with no evidence of malignancy, infection, current or old TB.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women, or women who are planning pregnancy.
- Patients not suitable for TNF alfa inhibitors therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab, etanercept, infliximabAdalimumab 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. | Drug | TNF alfa inhibitors |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 19641206Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med. 2009 Jul 30;361(5):496-509. doi: 10.1056/NEJMra0804595. No abstract available.
- Background: PubMed 17489975Bedini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDREA PESERICO, PROF study chair
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab, etanercept, infliximab in people with Moderate to Severe Psoriasis. and Absolute Number, Density of Immune Infiltrate and Dendritic Cells and Inflammatory Cytokines Expression Pattern., run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STEFANO PIASERICO, MD (0498212901 ext. 0039, andrea.peserico@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237262, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.