Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Tre
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
| Condition(s) | Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab, Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 tran |
| Who can participate | Inclusion Criteria: * Age \> 18 years old * Patient with: * A diagnosis of rheumatoid arthritis according to ACR EULAR 2010 classification criteria * Or a diagnosis of polymyalgia rheumatica according to ACR EULAR 2012 classification criteria * Or a diagnosis of giant cell arteritis (with or without polymyalgia rheumatica associated) according to 2022 revised classification criteria * Or a diagnosis of systemic sclerosis according to ACR EULAR 2013 classification criteria * Or a diagnosis of Takayasu vasculitis according to ACR 2022 classification criteria * Or a diagnosis of Still disease according to Yamaguchi or Fautrel classification criteria * Or a diagnosis of VEXAS with UBA1 somatic mutation * Or a diagnosis of unclassified autoimmune or auto-inflammatory disease treated by tocilizu |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Locations | Clermont-Ferrand, France |
| Start date | 2024-04-03 |
| NCT ID | NCT06654154 |
| Official listing | https://clinicaltrials.gov/study/NCT06654154 |