Actively Recruiting
Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
Led by University Hospital, Clermont-Ferrand · Updated on 2024-10-23
56
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Tocilizumab is a monoclonal antibody that acts as an IL-6 receptor antagonist It is responsible for a reduction in the hepatic synthesis of inflammatory proteins, including CRP (C-reactive protein). Thus, the diagnosis of a relapse of the autoimmune or auto inflammatory disease (AI/ID) or an infection is made difficult in patients treated with tocilizumab and there is to date no marker of inflammation validated in patients receiving tocilizumab. Vitamin B12 is an essential element that participates to haematopoiesis, myelin integrity, neuronal function and DNA synthesis. Vitamin B12 is carried by haptocorrin and transcobalamin II (TCII). Vitamin B12 increases in many pathological situations, including infections and AI/ID due to the increase of its transport proteins elevation (mostly transcobalamin II). The sponsor did not find any study in the literature studying the level of vitamin B12 or TCII in patients taking tocilizumab. The sponsor also did not find any physiopathological argument in favor of an inhibition of TCII synthesis by tocilizumab. As such, TCII dosage could be of interest, but the dosage is not available in routine whereas vitamin B12 dosage is available in every laboratory and is four times cheaper.
CONDITIONS
Official Title
Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years old
- Diagnosis of rheumatoid arthritis according to ACR EULAR 2010 criteria
- Or diagnosis of polymyalgia rheumatica according to ACR EULAR 2012 criteria
- Or diagnosis of giant cell arteritis with or without polymyalgia rheumatica per 2022 criteria
- Or diagnosis of systemic sclerosis according to ACR EULAR 2013 criteria
- Or diagnosis of Takayasu vasculitis according to ACR 2022 criteria
- Or diagnosis of Still disease per Yamaguchi or Fautrel criteria
- Or diagnosis of VEXAS with UBA1 somatic mutation
- Or diagnosis of unclassified autoimmune or autoinflammatory disease treated by tocilizumab
- Receiving intravenous or subcutaneous tocilizumab treatment
- Capable of giving informed consent
- Covered by a social protection system
You will not qualify if you...
- Taking oral or subcutaneous vitamin B12
- Pregnant or breastfeeding women
- Under guardianship, curatorship, deprived of liberty, or judicial protection
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU clermont-ferrand
Clermont-Ferrand, France
Actively Recruiting
Research Team
M
Melissa CLEMENT, Dr
CONTACT
M
Marc RUIVARD, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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