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Rituximab-pvvr and Abatacept Vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Study details:
This is a two-arm, double-blind, multicenter clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in individuals with new onset T1D to determine whether rituximab-pvvr followed by abatacept results in an improvement in the AUC C-Peptide during a MMTT compared to Rituximab-pvvr alone at 24 months. Additional aims will compare the safety, tolerability in the two treatment arms as well as other clinical metabolic measures: exogenous insulin use, hemoglobin A1c, time in range from continuous glucose monitors, and severe hypoglycemia. Exploratory studies will assess changes in immune markers.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 8 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-30
Primary completion: 2027-10-01
Study completion finish: 2029-10-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT03929601
Intervention or treatment
DRUG: Rituximab-pvvr
DRUG: Abatacept
DRUG: Sterile Sodium Chloride
Conditions
- • Type 1 Diabetes Mellitus
Find a site
Closest Location:
Queensland Children's Hospital
Research sites nearby
Select from list below to view details:
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Walter and Eliza Hall Institute of Medical Research
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: Rituximab-pvvr followed by Abatacept
| DRUG: Rituximab-pvvr
|
PLACEBO_COMPARATOR: Rituximab-pvvr followed by Placebo
| DRUG: Rituximab-pvvr
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
C-Peptide Response to 2-hr MMTT at 24 months post-randomization | The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab compared to those participants treated with Rituximab and placebo 24 months after enrollment. | 48-months from Day 0 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
C-peptide AUC Means | C-peptide AUC Mean at 0, 6, 12, 18, 24, 30, 36, 42 and 48 months using the ANCOVA model. | Day 0 and every 6 months to trial end (up to 4 years) |
Analysis of changes in immune responses to known diabetes antigens and a neoantigen over time by treatment group | Analysis of changes in immune responses to known diabetes antigens and a neoantigen. The investigators will compare the effects of drug treatments on the titers of autoantibodies: anti-insulin, anti-GAD65, anti-IA-2, anti-ZnT8. The investigators will also compare the effects of drug treatments on the response to Keyhole Limpet Hemocyanin (KLH) for which standardized immunological responses have been characterized. | Day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36 |
Frequently Asked Questions
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