Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT07041268
Eligibility Criteria:
Inclusion 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 randomized 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07041268
Study Brief:
Protocol Section:
NCT07041268