An observational study in Rheumatoid Arthritis, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by University Hospital, Montpellier · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 200 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria who have one of the following conditions:
Exclusion criteria:
serum IL6 levels.
serum IL6 levels. From first COVID-19 symtpoms, or first positive SARS-COV2 PCR result, to recovery.
Time frame: 1 day
The clinical correlations das 28 with the serum IL6 level
The clinical correlations das 28 with the serum IL6 level
Time frame: 1 day
Plan to share: Undecided — NC
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier