Psoriatic Inflammation Markers Predictive of Response to Adalimumab

Psoriasis Vulgaris Clinical Trial

— IMPRA  

Official title:

Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389984
• Other study ID #: IMPRA
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: June 18, 2020

Study information

• Verified date: September 2020
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 18, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Diagnostic Test:
• cutaneous
SKIN BIOPSY

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment	messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction	From baseline to 16 weeks treatment
Secondary	Change from baseline drug and anti-drug concentrations at 16 weeks of treatment	assessed by enzyme-linked-immunoassay	From baseline to 16 weeks treatment