Biomarkers in Rheumatoid Arthritis Treated With Anti-interleukin-6 Therapy
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT04281602
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
The use of anti-interleukin (IL)-6 therapy, including tocilizumab, in rheumatoid arthritis or giant cell arteritis, led to the improvement or even control of disease in some patients for whom no further therapeutic options were available. Nevertheless, the evaluation of the efficacy of these treatments are negatively impacted by the lack of reliable biomarkers. Indeed, usual inflammatory biomarkers used during the follow-up of these patients to detect persistent disease activity or intercurrent infection, such as C-reactive protein, fibrinogen and procalcitonin, are dependant on IL-6. Thse usual biomarkers cannot therefore be reliably used during anti-IL-6 therapy. Some other experimental biomarkers are totally or partially independent of IL-6, or even of inflammasome, and thus are credible candidates for the follow-up of patients treated with anti-IL-6 therapy.
Here investigators propose a controlled, prospective, monocentric, observational study evaluating several biomarkers, usual and experimental, in patients suffering from rheumatoid arthritis treated with anti-IL-6 therapy.
This study will include 25 patients suffering from rheumatoid arthritis requiring an anti-IL-6 therapy and 25 healthy controls.
In patients suffering from rheumatoid arthritis, usual and experimental biomarkers will be assessed at D0, D15, W24 and W52 from the introduction of anti-IL-6 therapy, or during an intercurrent infection.
Investigators thus hypothesized that experimental biomarker levels will still be increased at D15, contrary to usual biomarkers dependant on IL-6 which will be normal whereas rheumatoid arthritis is still active based on usual radiological and clinical criteria, and that all biomarkers will be normal a W24.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Levels of experimental biomarkers (IL-8, IL-1beta, IL-1RA, IL-4, IL-5, IL-6, IL-10, IL-12/23, IL-17, IL-18, IL-21, IFN-gamma, TNF-alpha, TGF-beta, S100 proteins, ceruloplasmin, C3, C4, CH50, serum amyloid A, factor VIII, neutrophil/lymphocyte ratio) Day 15 IL-8, IL-1beta, IL-1RA, IL-4, IL-5, IL-6, IL-10, IL-12/23, IL-17, IL-18, IL-21, IFN-gamma, TNF-alpha, TGF-beta and S100 proteins measured by Meso Scale Discovery assay, ceruloplasmin, C3, C4, serum amyloid A by nephelometry, CH50 by an enzyme immunoassay kit, factor VIII by turbidimetry, neutrophil/lymphocyte ratio by an automated method
Levels of usual biomarkers (C-reactive protein, fibrinogen, procalcitonin, serum protein electrophoresis) Day 15 C-reactive protein and fibrinogen measured by turbidimetry; procalcitonin by an enzyme immunoassay kit, serum protein electrophoresis by electrophoresis
- Secondary Outcome Measures
Name Time Method Levels of usual biomarkers (C-reactive protein, fibrinogen, procalcitonin, serum protein electrophoresis) Day 15 compared to Day 0 C-reactive protein and fibrinogen measured by turbidimetry; procalcitonin by an enzyme immunoassay kit, serum protein electrophoresis by electrophoresis
Levels of usual biomarkers (C-reactive protein, fibrinogen, procalcitonin, serum protein electrophoresis, erythrocyte sedimentation rate) Within 72 hours following infection occuring after week 24 C-reactive protein and fibrinogen measured by turbidimetry; procalcitonin by an enzyme immunoassay kit, serum protein electrophoresis by electrophoresis, erythrocyte sedimentation rate by an automated method
Levels of experimental biomarkers (IL-8, IL-1beta, IL-1RA, IL-4, IL-5, IL-6, IL-10, IL-12/23, IL-17, IL-18, IL-21, IFN-gamma, TNF-alpha, TGF-beta, S100 proteins, ceruloplasmin, C3, C4, CH50, serum amyloid A, factor VIII, neutrophil/lymphocyte ratio) Within 72 hours following infection occuring after week 24 IL-8, IL-1beta, IL-1RA, IL-4, IL-5, IL-6, IL-10, IL-12/23, IL-17, IL-18, IL-21, IFN-gamma, TNF-alpha, TGF-beta and S100 proteins measured by Meso Scale Discovery assay, ceruloplasmin, C3, C4, serum amyloid A by nephelometry, CH50 by an enzyme immunoassay kit, factor VIII by turbidimetry, neutrophil/lymphocyte ratio by an automated method
Trial Locations
- Locations (1)
CHU de Caen Normandie
🇫🇷Caen, France