Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
Primary Purpose
Chronic Plaque Psoriasis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
HUMIRA 40mg
Sponsored by
About this trial
This is an interventional trial for Chronic Plaque Psoriasis
Eligibility Criteria
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
Sites / Locations
- Chu Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab
Arm Description
Outcomes
Primary Outcome Measures
Analyze modifications of the skin inflammatory
comparaison skin biopsy in non-lesional area between skin biopsy lesional area
Secondary Outcome Measures
skin transcriptomic profile
5 mL blood sample for serum preparation
Full Information
NCT ID
NCT01872546
First Posted
March 27, 2013
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01872546
Brief Title
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
7. Study Design
Study Phase
Phase 2
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HUMIRA 40mg
Primary Outcome Measure Information:
Title
Analyze modifications of the skin inflammatory
Description
comparaison skin biopsy in non-lesional area between skin biopsy lesional area
Time Frame
1 month
Secondary Outcome Measure Information:
Title
skin transcriptomic profile
Description
5 mL blood sample for serum preparation
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
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Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
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