Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01872546
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis	Drug: HUMIRA 40mg	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Actual Primary Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adalimumab	Drug: HUMIRA 40mg

Outcome Measures

Primary Outcome Measures

1. Analyze modifications of the skin inflammatory [1 month]

   comparaison skin biopsy in non-lesional area between skin biopsy lesional area

Secondary Outcome Measures

1. skin transcriptomic profile [1 month]

   5 mL blood sample for serum preparation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Poitiers	Poitiers		France	86021

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT01872546
• Other Study ID Numbers: CYTOPSO
• First Posted: Jun 7, 2013
• Last Update Posted: Oct 11, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Psoriasis; Adalimumab

Study Results

No Results Posted as of Oct 11, 2016