Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Psoriatic Inflammation Markers Predictive of Response to Adalimumab (IMPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03389984
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Diagnostic Test: cutaneous Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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 : November 14, 2017
Estimated Primary Completion Date : September 14, 2019
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389984


Locations
Layout table for location information
France
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Hainaut Ewa, Dr    0549444459    ewa.hainaut@chu-poitiers.fr   
Sponsors and Collaborators
Poitiers University Hospital

Layout table for additonal information
Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03389984     History of Changes
Other Study ID Numbers: IMPRA
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents