Tocilizumab (TCZ) in New-onset Type 1 Diabetes

Conditions

• New-onset Type 1 Diabetes Mellitus
• T1D
• T1DM
• Type 1 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab (TCZ) — DRUG
  Subjects assigned to this group will receive tocilizumab intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.
• Placebo — DRUG
  Subjects assigned to this group will receive placebo intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.
• Standard of Care — OTHER
  Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines \[Standard of Care, SOC\])

Study Details

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control. Researchers believe that tocilizumab could have some effect on the cells in the immune system that are thought to be involved in the development of type 1 diabetes. This study will test whether tocilizumab can help preserve or delay destruction of remaining beta cells in people recently diagnosed type 1 diabetes.

Key Dates

Start date

Mar 12, 2015

Status verified

Aug 2021

Primary completion

Jul 10, 2019

Completion

Aug 31, 2020

Study Design

Enrollment

136 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab (TCZ) + SOC
  Subjects will receive intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥30 kg) or 10.0 mg/kg (body weight \<30kg) tocilizumab every 4 weeks for 24 weeks. Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines \[Standard of Care, SOC\])
• Placebo Comparator: Tocilizumab Placebo Group + SOC
  Subjects will receive IV infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) placebo every 4 weeks for 24 weeks. Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines \[Standard of Care, SOC\])

Primary Outcome Measure

Change From Baseline in 2-Hour C-peptide Mean Area Under the Curve (mAUC) in Pediatric Participants [ Time Frame: Baseline (Pre-treatment) to Week 52 ]

Locations (17)

Find similar trials in San Francisco, CA

Related Studies

• Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Long Term Follow up of Recipients of Functional Islet Allografts
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Type 1 Diabetes Extension Study
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California