Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654154
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-20
Brief Title:
Vitamin B12 a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vitamin B12 a Biological Marker of Systemic Disease or Infection Flare-up in Patients Treated with Tocilizumab
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOCI2C
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 AIID 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 AIID 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
Thus the diagnosis of a relapse of the autoimmune or auto inflammatory disease AIID 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 AIID 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 AIDI 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 MAII 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 patients 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
Also serum vitamin B12 will be measured during a biological assessment carried out either in the event of a suspected outbreak of MAII 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None