Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Determination of serum level of vitamin B12 and data collection in a patient:

* At study inclusion
* If an infection or a AI/ID relapse is suspected
* At remission in case if inclusion during AI/ID relapse
* At tocilizumab initiation if happening along with inclusion
* At Day 3 (+/-1) if an infection or AI/ID relapse is suspected and if the patient is hospitalized and if a blood test is realised

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Each patient is his own witness to express the variation in the serum level of vitamin B12: this way we overcome individual variability.

Study Groups

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study the variation in serum vitamin B12 level

Each patient is his own witness to express the variation in the serum level of vitamin B12

Group Type OTHER

variation of serum level vitamine B12

Intervention Type 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 μl of venous blood but no additional venipuncture

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 tocilizumab
* 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

* Patient treated by oral or subcutaneous vitamin B12
* Pregnant or breastfeeding women
* Patient under guardianship or curatorship, deprived or liberty, placed under judicial protection
* Rejection to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No