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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01673-42 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study the variation in serum vitamin B12 level | Other | Each patient is his own witness to express the variation in the serum level of vitamin B12 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| variation of serum level vitamine B12 | Diagnostic Test | 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 ÎĽl of venous blood but no additional venipuncture |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | - 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Description of distribution of patients according to occurrence infection or AI/ID desease. | Occurrence of infection or autoimmune-autoinflammory desease. | from enrollment to the 3 years of the patient's participation |
| variation of serum vitamin B12 level (pmol/L) according the events |
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Inclusion Criteria:
Age > 18 years old
Patient with:
Receiving intravenous or subcutaneous tocilizumab (treatment can be introduce before inclusion or started at the inclusion)
Capable of giving informed consent
Covered by a social protection system
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa CLEMENT, Dr | Contact | 33 4 71 46 56 56 | mclement@ch-aurillac.fr | |
| Marc RUIVARD, Pr | Contact | 33 4 73 75 00 86 | mruivard@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marc RUIVARD, Pr | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU clermont-ferrand | Recruiting | Clermont-Ferrand | France |
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Determination of serum level of vitamin B12 and data collection in a patient:
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Each patient is his own witness to express the variation in the serum level of vitamin B12: this way we overcome individual variability.
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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 |
| 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 | 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 | 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 | 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) | 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 | 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 | 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
| 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 | from enrollment to the 3 years of the patient's participation |