Investigating Vitamin B12 Levels in Patients on Tocilizumab
Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
This study is trying to see if vitamin B12 levels change in patients with autoimmune diseases who are being treated with tocilizumab during flare-ups compared to when they're feeling better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06654154 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific autoimmune or auto-inflammatory diseases who are currently receiving tocilizumab.
Not a fit: Patients not receiving tocilizumab or those with conditions outside the specified autoimmune or auto-inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for diagnosing flare-ups of autoimmune diseases or infections in patients treated with tocilizumab.
How similar studies have performed: There are no known studies that have previously investigated vitamin B12 levels in patients treated with tocilizumab, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.