NCT06654154 Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
| NCT ID | NCT06654154 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2024-04-03 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Marc RUIVARD, Pr
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT06654154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654154 currently recruiting?
Yes, NCT06654154 is actively recruiting participants. Contact the research team at mclement@ch-aurillac.fr for enrollment information.
Where is the NCT06654154 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT06654154 clinical trial?
NCT06654154 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Marc RUIVARD, Pr at University Hospital, Clermont-Ferrand. The trial plans to enroll 56 participants.