search
Back to results

Psoriatic Inflammation Markers Predictive of Response to Adalimumab (IMPRA)

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cutaneous
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline messenger ribonucleic acid expression at 16 weeks of 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
assessed by enzyme-linked-immunoassay

Full Information

First Posted
December 6, 2017
Last Updated
September 22, 2020
Sponsor
Poitiers University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03389984
Brief Title
Psoriatic Inflammation Markers Predictive of Response to Adalimumab
Acronym
IMPRA
Official Title
Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
cutaneous
Intervention Description
SKIN BIOPSY
Primary Outcome Measure Information:
Title
Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment
Description
messenger ribonucleic acid expression assessed by quantitative reverse transcription-polymerase chain reaction
Time Frame
From baseline to 16 weeks treatment
Secondary Outcome Measure Information:
Title
Change from baseline drug and anti-drug concentrations at 16 weeks of treatment
Description
assessed by enzyme-linked-immunoassay
Time Frame
From baseline to 16 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Learn more about this trial

Psoriatic Inflammation Markers Predictive of Response to Adalimumab

We'll reach out to this number within 24 hrs