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REMISIX: IL-6 as a Biomarker for Personalized Treatment of PR

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04779983
Collaborator
(none)
200
Enrollment
1
Location
4.5
Actual Duration (Months)
44.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Several studies have shown the relevance of the IL6 level before treatment or after 6 months, as a predictive biomarker for the persistence of remission. The IL6 assay is now routinely available using the instruments available at the Montpellier University Hospital and with reagents provided by the ROCHE Laboratory. Moreover medical practices should incorporate this parameter. However, relevant threshold shlould be defined before being able to integrate biomarkers such as IL6 for monitoring bDMARDs in an algorithm.

The medical staff of Clinical Immunology Unit has decided to include the dosage of IL-6 during a routine biological assessment during patient visit to follow the new EULAR recommendations . This measument will be perfom in addition to the CRP and biochemical parameters on subjects with active RA or in remission upon the introduction of biological treatments or JAKi or during remission after at least 6 months of treatment. From March to July 2021, 200 patients will beenrolled and will benefit of this assessement. The investigators will retrospectively define clinical correlations with serum IL6 levels in order to define a threshold. In the second stage, a decisional algorithm based on the results of this project will be create. This will allow an improvement of the medical practices thanks to the integrationof of serum IL6 dosage as a standard during patients visits. The IL-6 assay will be performed on the e801 module of the Cobas lines (Roche Diagnostics) currently in place in the Biochemistry and Hormonology laboratory. The Elecsys® IL-6 - Roche Diagnostics test, high sensitivity, is an electrochemiluminescence immunoassay.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Professional Practices in the Prescription of Biological Treatments for RA Taking Into Account IL6 as a Biomarker
    Actual Study Start Date :
    Mar 18, 2021
    Actual Primary Completion Date :
    Jul 30, 2021
    Actual Study Completion Date :
    Aug 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. serum IL6 levels. [1 day]

      serum IL6 levels. From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.

    Secondary Outcome Measures

    1. The clinical correlations das 28 with the serum IL6 level [1 day]

      The clinical correlations das 28 with the serum IL6 level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • 18 to 65 years old

    • patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria who have one of the following conditions:

    • Subjects with active RA (DAS28> 3.6) who have failed methotrexate treatement and with a standard medical care for which an indication for biotherapy is retained or

    • Subjects with remission of RA (DAS28<2.6) for which a biotherapy delay (anti-TNF or anti-IL6R or JAKi) is proposed.

    Exclusion criteria:
    • Age under 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UH Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Christian Jorgensen, PU PH, University Hospitals of Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04779983
    Other Study ID Numbers:
    • RECHMPL21_0100
    First Posted:
    Mar 3, 2021
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    IL-6
    Biomarker
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Oct 19, 2021