Investigating Vitamin B12 Levels in Patients on Tocilizumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the changes in serum vitamin B12 levels in patients treated with tocilizumab who are experiencing a flare-up of autoimmune or auto-inflammatory diseases or infections. By comparing vitamin B12 levels during suspected flare-ups to those during remission, the study seeks to determine if vitamin B12 can serve as a reliable biological marker for these conditions in patients receiving tocilizumab. Blood samples will be collected during routine assessments without requiring additional venipuncture. The findings could help improve the diagnosis and management of patients undergoing treatment with tocilizumab.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU clermont-ferrand
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Marc RUIVARD, Pr — University Hospital, Clermont-Ferrand
• Study coordinator: Melissa CLEMENT, Dr
• Email: mclement@ch-aurillac.fr
• Phone: 33 4 71 46 56 56

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.