- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389984
Psoriatic Inflammation Markers Predictive of Response to Adalimumab (IMPRA)
September 22, 2020 updated by: Poitiers University Hospital
Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Poitiers, France, 86021
- CHU Poitiers
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adalimumab
|
SKIN BIOPSY
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline to 16 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline to 16 weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2017
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
June 18, 2020
Study Registration Dates
First Submitted
December 6, 2017
First Submitted That Met QC Criteria
December 27, 2017
First Posted (Actual)
January 4, 2018
Study Record Updates
Last Update Posted (Actual)
September 23, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPRA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis Vulgaris
-
LEO PharmaCompletedPlaque Psoriasis | Psoriasis VulgarisGermany
-
SoligenixRecruitingPsoriasis | Plaque Psoriasis | Psoriasis VulgarisUnited States
-
LEO PharmaTerminatedPsoriasis | Plaque Psoriasis | Psoriasis VulgarisBelgium, Germany, Italy, Spain, Denmark, Austria, France, Greece, Switzerland, United Kingdom, Netherlands, Sweden
-
PRCL Research Inc.CompletedPlaque Psoriasis | Psoriasis VulgarisCanada, Slovakia, Ukraine
-
Chinese University of Hong KongNot yet recruitingPsoriasis Vulgaris
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University Hospital, GhentRecruitingPsoriasis VulgarisBelgium
-
University of California, San FranciscoNovartis Pharmaceuticals; National Psoriasis FoundationRecruitingPsoriasis VulgarisUnited States
-
University of California, San FranciscoSun Pharmaceutical Industries LimitedRecruiting
-
Centre for Human Drug Research, NetherlandsJanssen PharmaceuticalsRecruiting
Clinical Trials on cutaneous
-
Central Hospital, Nancy, FranceUnknown
-
Stanford UniversityCompleted
-
University Hospital, Strasbourg, FranceSociété de Dermatologie FrançaiseActive, not recruiting
-
University Hospital, AngersUnknown
-
Cairo UniversityRecruiting
-
Balgrist University HospitalCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedMortality | Intensive Care Unit | ReliabilityFrance
-
University Hospital, MontpellierTerminated
-
Legacy Healthcare SACompleted