Status:
COMPLETED
Psoriatic Inflammation Markers Predictive of Response to Adalimumab
Lead Sponsor:
Poitiers University Hospital
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index...
Eligibility Criteria
Inclusion
- Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score \>10,
- Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception,
- Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis),
- Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed
Exclusion
- Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection),
- History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer
- Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis
- Ongoing pregnancy or breastfeeding
- Absence of written consent,
- Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03389984
Start Date
November 14 2017
End Date
June 18 2020
Last Update
September 23 2020
Active Locations (1)
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1
CHU Poitiers
Poitiers, France, 86021