Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under TocilizumabTOCI2CNCT06654154
Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
A study testing variation of serum level vitamine B12 in people with Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab and Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- variation of serum level vitamine B12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise LACLAUTRE, 334.73.754.963, llaclautre_perrier@chu-clermontferrand.fr
Marc RUIVARD, Pr
About this study
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.
Read more
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.
Read the detailed description
The main objective is to study the variation in serum vitamin B12 level in case of clinical suspicion of AID/I flare or infection in patients treated with tocilizumab compared to the B12 level of the patient in remission period. , and excluding infection, under tocilizumab
Also, serum vitamin B12 will be measured during a biological assessment carried out either in the event of a suspected outbreak of MAI/I or infection, or in the event of remission (during the follow-up assessment carried out systematically in a patient on tocilizumab).
This determination of serum vitamin B12 will be carried out during a blood test carried out at the request of the patient's doctor.
The study will involve taking an additional tube of venous blood but will not result in additional venipuncture.
There will be no specific visit related to the study.
- 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
- Being tested
- variation of serum level vitamine B12
- Keywords
- vitamin B12, Tocilizumabe, autoimmune desease, auto-inflammatory disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
variation of serum level vitamine B12Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| study the variation in serum vitamin B12 level | Other | Each patient is his own witness to express the variation in the serum level of vitamin B12 Receives: Diagnostic Test: variation of serum level vitamine B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variationof serum level of vitamin B12 (pmol/L) between a clinical suspicion of relapse autoimmune or autoinflammatory desease (AI/ID) or infection and a remission state, in patients treated by tocilizumab.
Percentage change of vitamin B12 serum level (pmol/L) between a remission state without infection ongoing and an relapse AI/ID or an infection.
Measured: - At study inclusion - During the 3 years of the patient's participation and if included during a remission, new sample in case of suspicion of new infection or recurrence of autoimmune or inflammatory disease - During the 3 years of the patient's par
Secondary outcomes (10)
Description of distribution of patients according to occurrence infection or AI/ID desease.
Occurrence of infection or autoimmune-autoinflammory desease.
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the events
Percentage change of vitamin B12 serum level (pmol/L) between level in remission and level in relapse AI/ID or infection Percentage change of vitamin B12 serum level (pmol/L) between level at the start (J0) of relapse AI/ID or infection and at J3 of the start of relapse AI/ID or infection
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according event under treatment
Percentage change of vitamin B12 serum level (pmol/L) under Tocilizumab between level in remission and level in relapse AI/ID or infection
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the duration of treatment by tocilizumab
Percentage change of vitamin B12 serum level (pmol/L) according the duration of treatment and occurrence of relapse of AI/ID or infection
l
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according Previous AI/ID treatment
According the previous treatment, percentage change of vitamin B12 serum level (pmol/L) at the inclusion
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according patients characteristics
Percentage change of vitamin B12 serum level (pmol/L) according to sexe (women-man) Percentage change of vitamin B12 serum level (pmol/L) according to weight (kg) Percentage change of vitamin B12 serum level (pmol/L) according to age (years)
Measured: from enrollment to the 3 years of the patient's participation
Comparaison of the level serum vitamin B12 level (pmol/L) in relapse AI/ID or infection with other inflammatory markers:
comparaison between the level vitamin B12 serum and the level of CRP (mg/L) and fibrogène (g/L) performed at the same time during study
Measured: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the way of tocilizumab administration
Percentage change of vitamin B12 serum level (pmol/L) according to tocilizumab is administrated by intravenous or sub cutaneous
Measured: from enrollment to the 3 years of the patient's participation
To compare vitamin B12 serum level (in pmol/L) variation between: infection with tocilizumab / relapse AI/ID with or without tocilizumab / remission state with tocilizumab
change of serum level of vitamin B12 (in pmol/L) between sample performed at inclusion and
- sample performed at Infection without tocilizumab and at remission state with tocilizumab
- sample performed at relapse AI/ID without tocilizumab and at remission state with tocilizumab
- sample performed at relapse AI/ID with or without tocilizumab
Measured: from enrollment to the 3 years of the patient's participation
To study presence of a vitamin B12 serum level (in pmol/L) greater than upper laboratory bound if infection or relapse AI/ID (without tocilizumab) and to compare objectives cited in 2 according to this serum level.
Vitamin B12 serum level (in pmol/L) and the presence of serum level of vitamin B12 greater than upper laboratory bound (at University hospital at Clermont fd the normal range are between 178-584 pmol/L
Measured: from enrollment to the 3 years of the patient's participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start3 Apr 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under TocilizumabStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Determination of serum level of vitamin B12 and data collection in a patient: * At study inclusion * If an infection or a AI/ID relapse is suspected * At remission in case if inclusion during AI/ID relapse * At tocilizumab initiation if happening along with inclusion * At Day 3 (+/-1) if an infection or AI/ID relapse is suspected and if the patient is hospitalized and if a blood test is realised
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc RUIVARD, Pr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654154
- Sponsor's protocol ID
- RNI 2023 CLEMENT
- Other IDs
- 2023-A01673-42
- Acronym
- TOCI2C
- Status last verified
- Oct 2024
- First submitted
- 20 Mar 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B12: a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab?
- ClinicalTrials.gov ID
- NCT06654154
- Acronym / sponsor ID
- TOCI2C / RNI 2023 CLEMENT
- 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
- Keywords
- vitamin B12, Tocilizumabe, autoimmune desease, auto-inflammatory disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main objective is to study the variation in serum vitamin B12 level in case of clinical suspicion of AID/I flare or infection in patients treated with tocilizumab compared to the B12 level of the patient in remission period. , and excluding infection, under tocilizumab
Also, serum vitamin B12 will be measured during a biological assessment carried out either in the event of a suspected outbreak of MAI/I or infection, or in the event of remission (during the follow-up assessment carried out systematically in a patient on tocilizumab).
This determination of serum vitamin B12 will be carried out during a blood test carried out at the request of the patient's doctor.
The study will involve taking an additional tube of venous blood but will not result in additional venipuncture.
There will be no specific visit related to the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determination of serum level of vitamin B12 and data collection in a patient: * At study inclusion * If an infection or a AI/ID relapse is suspected * At remission in case if inclusion during AI/ID relapse * At tocilizumab initiation if happening along with inclusion * At Day 3 (+/-1) if an infection or AI/ID relapse is suspected and if the patient is hospitalized and if a blood test is realised
| Arm | Type | Receives |
|---|---|---|
| study the variation in serum vitamin B12 level | Other | Diagnostic Test: variation of serum level vitamine B12Each patient is his own witness to express the variation in the serum level of vitamin B12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age > 18 years old
- Patient with:
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| variation of serum level vitamine B12There 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 | Diagnostic test | study the variation in serum vitamin B12 level |
Primary outcome
Variationof serum level of vitamin B12 (pmol/L) between a clinical suspicion of relapse autoimmune or autoinflammatory desease (AI/ID) or infection and a remission state, in patients treated by tocilizumab.
Time frame: - At study inclusion - During the 3 years of the patient's participation and if included during a remission, new sample in case of suspicion of new infection or recurrence of autoimmune or inflammatory disease - During the 3 years of the patient's par
Percentage change of vitamin B12 serum level (pmol/L) between a remission state without infection ongoing and an relapse AI/ID or an infection.
10 secondary outcomes
Description of distribution of patients according to occurrence infection or AI/ID desease.
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the events
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according event under treatment
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the duration of treatment by tocilizumab
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according Previous AI/ID treatment
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according patients characteristics
Time frame: from enrollment to the 3 years of the patient's participation
Comparaison of the level serum vitamin B12 level (pmol/L) in relapse AI/ID or infection with other inflammatory markers:
Time frame: from enrollment to the 3 years of the patient's participation
variation of serum vitamin B12 level (pmol/L) according the way of tocilizumab administration
Time frame: from enrollment to the 3 years of the patient's participation
To compare vitamin B12 serum level (in pmol/L) variation between: infection with tocilizumab / relapse AI/ID with or without tocilizumab / remission state with tocilizumab
Time frame: from enrollment to the 3 years of the patient's participation
To study presence of a vitamin B12 serum level (in pmol/L) greater than upper laboratory bound if infection or relapse AI/ID (without tocilizumab) and to compare objectives cited in 2 according to this serum level.
Time frame: from enrollment to the 3 years of the patient's participation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc RUIVARD, Pr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing variation of serum level vitamine B12 in people with Level of Serum Vitamin B12 Level (in Pmol/L) If Relapse of (AI/ID) Under Tocilizumab and Level of Serum Vitamin B12 Level (in Pmol/L) If Infection Under Tocilizumab, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa CLEMENT, Dr (33 4 71 46 56 56, mclement@ch-aurillac.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variationof serum level of vitamin B12 (pmol/L) between a clinical suspicion of relapse autoimmune or autoinflammatory desease (AI/ID) or infection and a remission state, in patients treated by tocilizumab. (time frame: - At study inclusion - During the 3 years of the patient's participation and if included during a remission, new sample in case of suspicion of new infection or recurrence of autoimmune or inflammatory disease - During the 3 years of the patient's par). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.