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

NCT06654154 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-10-23

No results posted yet for this study

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 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

  • 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

Interventions

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Marc RUIVARD, Pr · University Hospital, Clermont-Ferrand

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2026-03-31
Completion
2029-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654154 on ClinicalTrials.gov