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Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

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ClinicalTrials.gov Identifier: NCT01872546
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Plaque Psoriasis Drug: HUMIRA 40mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

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



Primary Outcome Measures :
  1. Analyze modifications of the skin inflammatory [ Time Frame: 1 month ]
    comparaison skin biopsy in non-lesional area between skin biopsy lesional area


Secondary Outcome Measures :
  1. skin transcriptomic profile [ Time Frame: 1 month ]
    5 mL blood sample for serum preparation



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872546


Locations
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France
Chu Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01872546     History of Changes
Other Study ID Numbers: CYTOPSO
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents