Psoriatic Inflammation Markers Predictive of Response to Adalimumab

NCT03389984 | Completed

• 1 other identifier: IMPRA
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline drug and anti-drug concentrations at 16 weeks of treatment

  From baseline to 16 weeks treatment

Study Arms (1)

Adalimumab

EXPERIMENTAL

Diagnostic Test: cutaneous

Interventions

cutaneous DIAGNOSTIC_TEST

SKIN BIOPSY

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 4, 2018
• Study Start: November 14, 2017
• Primary Completion: November 30, 2019
• Study Completion: June 18, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

FR (1)