An interventional study of variation of serum level vitamine B12 in Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab and Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic
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.
The main objective is to study the variation in serum vitamin B12 level in case of clinical suspicion of AID/I flare or infection in patients treated with tocilizumab compared to the B12 level of the patient in remission period. , and excluding infection, under tocilizumab
Also, serum vitamin B12 will be measured during a biological assessment carried out either in the event of a suspected outbreak of MAI/I or infection, or in the event of remission (during the follow-up assessment carried out systematically in a patient on tocilizumab).
This determination of serum vitamin B12 will be carried out during a blood test carried out at the request of the patient's doctor.
The study will involve taking an additional tube of venous blood but will not result in additional venipuncture.
There will be no specific visit related to the study.
University Hospital, Clermont-Ferrand is the lead sponsor of 854 studies on the registry; 180 are open to participants now.
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Patient with:
Exclusion Criteria:
Each patient is his own witness to express the variation in the serum level of vitamin B12
Diagnostic Test: variation of serum level vitamine B12
There will be no specific visit to the study. Follow-up in consultation will be done by your referring doctor. A determination of the serum level of vitamin B12 will be carried out at inclusion, during a consultation where the pathology is in remission (during the classic assessment of follow-up under tocilizumab, left to the discretion of the patient's referring doctor. ). It will also be necessary to carry out, in addition to the classic assessment left to the discretion of the patient's doctor, a determination of the serum level of vitamin B12 in the event of clinical suspicion of infection or an outbreak of MAI/I. The determination of serum vitamin B12 requires the collection of an additional tube of 300 μl of venous blood but no additional venipuncture
Variationof serum level of vitamin B12 (pmol/L) between a clinical suspicion of relapse autoimmune or autoinflammatory desease (AI/ID) or infection and a remission state, in patients treated by tocilizumab.
Percentage change of vitamin B12 serum level (pmol/L) between a remission state without infection ongoing and an relapse AI/ID or an infection.
Time frame: - At study inclusion - During the 3 years of the patient's participation and if included during a remission, new sample in case of suspicion of new infection or recurrence of autoimmune or inflammatory disease - During the 3 years of the patient's par
Description of distribution of patients according to occurrence infection or AI/ID desease.
Occurrence of infection or autoimmune-autoinflammory desease.
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the events
Percentage change of vitamin B12 serum level (pmol/L) between level in remission and level in relapse AI/ID or infection Percentage change of vitamin B12 serum level (pmol/L) between level at the start (J0) of relapse AI/ID or infection and at J3 of the start of relapse AI/ID or infection
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according event under treatment
Percentage change of vitamin B12 serum level (pmol/L) under Tocilizumab between level in remission and level in relapse AI/ID or infection
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the duration of treatment by tocilizumab
Percentage change of vitamin B12 serum level (pmol/L) according the duration of treatment and occurrence of relapse of AI/ID or infection l
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according Previous AI/ID treatment
According the previous treatment, percentage change of vitamin B12 serum level (pmol/L) at the inclusion
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according patients characteristics
Percentage change of vitamin B12 serum level (pmol/L) according to sexe (women-man) Percentage change of vitamin B12 serum level (pmol/L) according to weight (kg) Percentage change of vitamin B12 serum level (pmol/L) according to age (years)
Time frame: from enrollment to the 3 years of the patient's participation
Comparaison of the level serum vitamin B12 level (pmol/L) in relapse AI/ID or infection with other inflammatory markers:
comparaison between the level vitamin B12 serum and the level of CRP (mg/L) and fibrogène (g/L) performed at the same time during study
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the way of tocilizumab administration
Percentage change of vitamin B12 serum level (pmol/L) according to tocilizumab is administrated by intravenous or sub cutaneous
Time frame: from enrollment to the 3 years of the patient's participation
To compare vitamin B12 serum level (in pmol/L) variation between: infection with tocilizumab / relapse AI/ID with or without tocilizumab / remission state with tocilizumab
change of serum level of vitamin B12 (in pmol/L) between sample performed at inclusion and * sample performed at Infection without tocilizumab and at remission state with tocilizumab * sample performed at relapse AI/ID without tocilizumab and at remission state with tocilizumab * sample performed at relapse AI/ID with or without tocilizumab
Time frame: from enrollment to the 3 years of the patient's participation
To study presence of a vitamin B12 serum level (in pmol/L) greater than upper laboratory bound if infection or relapse AI/ID (without tocilizumab) and to compare objectives cited in 2 according to this serum level.
Vitamin B12 serum level (in pmol/L) and the presence of serum level of vitamin B12 greater than upper laboratory bound (at University hospital at Clermont fd the normal range are between 178-584 pmol/L
Time frame: from enrollment to the 3 years of the patient's participation
Plan to share: No
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