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New treatment option for Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID)...
Official title Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
ClinicalTrials.gov ID: NCT06654154
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.