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OpenTrials
Completed

NCT Number: NCT03389984

Psoriatic Inflammation Markers Predictive of Response to Adalimumab

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.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cutaneous

Diagnostic Test

SKIN BIOPSY

Primary outcomes

  1. Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment

    Time frame: From baseline to 16 weeks treatment

    messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction

Secondary outcomes

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

    Time frame: From baseline to 16 weeks treatment

    assessed by enzyme-linked-immunoassay

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: IMPRA

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 4, 2018
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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