IL-6 as a Biomarker for Personalized Treatment of PR

NCT04779983 | Completed

• 1 other identifier: RECHMPL21_0100
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

IL-6; Biomarker

Outcome Measures

Primary Outcomes (1)

• serum IL6 levels.

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

  1 day

Secondary Outcomes (1)

• The clinical correlations das 28 with the serum IL6 level

  1 day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \- Age under 18 years old

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Christian Jorgensen, PU PH

  University Hospitals of Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: March 18, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 1, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (1)