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NCT01872546 Clinical Trial

Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

Chronic Plaque Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01872546
Other study ID # CYTOPSO
Secondary ID
Status Completed
Phase Phase 2
First received March 27, 2013
Last updated October 10, 2016

Study information
Verified date October 2016
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers
Gender Both
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Patients with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.

- Adalimumab prescribed in usual practice

Exclusion Criteria:

- Patients presenting a contraindication to the use of Adalimumab:

hypersensibility in Adalimumab or in one of the excipients.

- Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections

- presenting patients one cardiac insufficiencies moderated in severe

- Patients under anakinra or abatacept

- current participation in another study of clinical research

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• HUMIRA 40mg

Locations
Country Name City State
France Chu Poitiers Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analyze modifications of the skin inflammatory comparaison skin biopsy in non-lesional area between skin biopsy lesional area 1 month
Secondary skin transcriptomic profile 5 mL blood sample for serum preparation 1 month
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