Psoriatic Inflammation Markers Predictive of Response to Adalimumab

Not Applicable

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Diagnostic Test: cutaneous

• Registration Number: NCT03389984
• Lead Sponsor: Poitiers University Hospital

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 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-04
• Primary Completion: 2019-11-30
• Study Completion: 2020-06-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	cutaneous	-

Primary Outcome Measures

Name	Time	Method
Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment	From baseline to 16 weeks treatment	messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction

Secondary Outcome Measures

Name	Time	Method
Change from baseline drug and anti-drug concentrations at 16 weeks of treatment	From baseline to 16 weeks treatment	assessed by enzyme-linked-immunoassay

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France