Repeated rituximab infusions for recent-onset type 1 diabetes in adolescents
Evaluation of Effectiveness and Safety of the Rituximab Immunotherapy Plus Insulin Therapy Compared to Insulin Therapy Alone in Adolescents With Recent-Onset Type 1 Diabetes Mellitus
This test tries repeated rituximab infusions alongside regular insulin in adolescents 12–17 with recent-onset type 1 diabetes to see if it helps preserve their insulin-producing beta cells.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Pirogov Russian National Research Medical University Academic / other |
| Drugs / interventions | rituximab |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT07041268 on ClinicalTrials.gov |
What this trial studies
This is a non-randomized, open-label, two-arm study in which participants (or their guardians) choose either repeated rituximab infusions plus standard insulin therapy or insulin therapy alone. The rituximab arm receives 14 intravenous infusions over one year with 13 hospital visits, while the insulin-only arm attends five clinic visits over the same period. Beta-cell function will be tracked by mixed-meal tolerance tests measuring C‑peptide at baseline and at weeks 12, 19, 26, and 52 with samples taken fasting and at 15, 30, 60, 90, and 120 minutes. Enrollment is limited to Russian citizens aged 12–17 within four months of T1D diagnosis who have a stimulated C‑peptide ≥200 pmol/L and at least one diabetes autoantibody.
Who should consider this trial
Good fit: Adolescents aged 12–17 who are Russian citizens, diagnosed with type 1 diabetes within the past four months, have a stimulated C‑peptide ≥200 pmol/L and a positive diabetes autoantibody are ideal candidates.
Not a fit: Patients with diabetes diagnosed more than four months earlier, very low or absent C‑peptide, active non-thyroid autoimmune disease, inability to attend frequent Moscow visits, or who do not meet age/weight/citizenship criteria are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, repeated rituximab could slow loss of insulin-producing beta cells in adolescents with new-onset T1D, lowering insulin requirements and delaying diabetes-related complications.
How similar studies have performed: Prior clinical trials of rituximab in new-onset T1D showed transient preservation of C‑peptide for about a year, so this repeated-dosing approach builds on that limited, time-limited benefit.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow and 1 other locations
- I.M. Sechenov First Moscow State Medical University (Sechenov University) — Moscow, Russia (Recruiting)
- Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Elena S Demina, M.D. — Russian Children's Clinical Hospital, Pirogov Russian National Research Medical University
- Study coordinator: Elena E Petryaykina, M.D.
- Email: director@rdkb.ru
- Phone: +79039756179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.