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New treatment option for Diabetes Mellitus, Type 1
Official title Immunotherapy of the Recent-onset Type 1 Diabetes in Adolescents With Repeated Courses of Rituximab
ClinicalTrials.gov ID: NCT07041268
What this study is testing
What is rituximab?
rituximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diabetes mellitus, type 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Type 1 diabetes (T1D) is caused by destruction of pancreatic islet beta-cells that produce insulin - the hormone required for glucose uptake by body tissues and organs. Since loss of beta-cells leads to insulin deficiency, blood glucose increases and the symptoms of T1D (thirst, hunger, excessive urination) appear.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- Is 12 years to 17 years 5 months of age, inclusive, at the time of randomization/initiation of rituximab administration
- Body weight 34-80 kg for males, and 37-80 for females
- Has received a diagnosis of type 1 diabetes mellitus (T1D), ICD-10 codes E10.1 or E10.9, according to the criteria from the Russian Association of...
- The duration of T1D (time from diagnosis to screening) is \< 4 months
- Is able to be assigned by chance and initiate rituximab infusions within 4 months (122 days) of the formal T1D diagnosis
You likely can't join if
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence of current or past infection with Mycobacterium tuberculosis, human immunodeficiency virus (HIV), hepatitis B...
- Has a history of primary immunodeficiency
- Has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion...
- Participant AND his/her legally authorized representative have not signed the Informed Consent Form
See the full eligibility criteria
- Is 12 years to 17 years 5 months of age, inclusive, at the time of randomization/initiation of rituximab administration
- Body weight 34-80 kg for males, and 37-80 for females
- Has received a diagnosis of type 1 diabetes mellitus (T1D), ICD-10 codes E10.1 or E10.9, according to the criteria from the Russian Association of Endocrinologists
- The duration of T1D (time from diagnosis to screening) is \< 4 months
- Is able to be assigned by chance and initiate rituximab infusions within 4 months (122 days) of the formal T1D diagnosis
- Has a peak stimulated C-peptide of ≥ 200 pmol/L from a MMTT at screening
- Is positive for at least one of T1D-related autoantibodies (ICA, GADA, IA-2A, ZnT8A) at screening
- Participant AND his/her legally authorized representative have signed the Informed Consent Form
- Citizenship of the Russian Federation
- Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
- Has an active infection and/or fever
- Has a history of or serologic evidence of current or past infection with Mycobacterium tuberculosis, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening
- Has a history of primary immunodeficiency
- Has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial
- Participant AND his/her legally authorized representative have not signed the Informed Consent Form
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.