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Clinical Trials/NCT01872546
NCT01872546CompletedPhase 2

Characterization of Skin Th17 Transcriptional Profiles in Psoriatic Patients Under Adalimumab Biotherapy

Poitiers University Hospital2 sites in 1 country18 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Analyze modifications of the skin inflammatory

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults 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.
  • Patients with one cardiac insufficiencies moderated in severe.
  • Patients under anakinra or abatacept.
  • Patients with a current participation in another study of clinical research.

Arms & Interventions

Adalimumab

Experimental

Intervention: HUMIRA 40mg (Drug)

Outcomes

Primary Outcomes

Analyze modifications of the skin inflammatory

Time Frame: 1 month

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

Secondary Outcomes

  • skin transcriptomic profile(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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