IMPRA: Psoriatic Inflammation Markers Predictive of Response to Adalimumab

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03389984

Collaborator

(none)

Enrollment

Location

Arm

31.1

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Diagnostic Test: cutaneous	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 14, 2017

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Jun 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adalimumab	Diagnostic Test: cutaneous SKIN BIOPSY

Arm

Intervention/Treatment

Experimental: Adalimumab

Diagnostic Test: cutaneous

SKIN BIOPSY

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Poitiers	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT03389984

Other Study ID Numbers:

IMPRA

First Posted:

Jan 4, 2018

Last Update Posted:

Sep 23, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Sep 23, 2020