Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

Sponsor
Yang Tao
Study ID
NCT01280682
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Study Details

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.

Key Dates

Start date
Jul 31, 2010
Status verified
Mar 2023
Primary completion
Dec 31, 2016
Completion
Dec 31, 2018

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab
    patients who had newly diagnosed type 1 diabetes are assigned to receive infusions of rituximab of 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8) besides insulin
  • No Intervention: parallel control
    patients who had newly diagnosed type 1 diabetes only use insulin

Primary Outcome Measure

Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide [ Time Frame: 6 months after participants completed the injection ]

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