Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

Phase 2

Completed

• Conditions: Chronic Plaque Psoriasis
• Interventions: Drug: HUMIRA 40mg

• Registration Number: NCT01872546
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Primary Completion: 2013-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adalimumab	HUMIRA 40mg	-

Primary Outcome Measures

Name	Time	Method
Analyze modifications of the skin inflammatory	1 month	comparaison skin biopsy in non-lesional area between skin biopsy lesional area

Secondary Outcome Measures

Name	Time	Method
skin transcriptomic profile	1 month	5 mL blood sample for serum preparation

Trial Locations

Locations (1)

Chu Poitiers; 🇫🇷 Poitiers, France