At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 120 enrolled
Drug / intervention
rituximabdrug
Likely dose
rituximab 125mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immune Intervention With Anti-CD20 Monoclonal Antibody to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
In Brief
A Phase 4 clinical trial evaluating rituximab for Type 1 Diabetes. Completed, enrolled 120 participants across 1 site.
Detailed Summary
Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedJan 2011
Primary CompletionDec 2016
Study CompletionDec 2018
TodayJul 2026
First PostedJan 21, 2011
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2016
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 15.4 years ago
Interventions
rituximabdrug
anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)