NCT00730392

Brief Summary

The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

August 5, 2008

Last Update Submit

April 26, 2023

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes, Etanercept, honeymoon period

Outcome Measures

Primary Outcomes (1)

  • The primary end points of this study are percent change from baseline for HbA1c and C-peptide area under the curve (AUC).

    At baseline and at the end of the 24-week blind treatment

Secondary Outcomes (1)

  • Secondary end points are insulin dose and number of insulin injection discontinued, if any

    At baseline and at end of the 24-week treatment period

Study Arms (1)

1 drug, 2 placebo

EXPERIMENTAL

1. Etanercept 2. Placebo

Drug: EtanerceptDrug: Placebo

Interventions

EtanerceptDRUG

The study drug was provided in lyophilized 10 mg vials to be reconstituted with 1 ml of diluent/vial and was administered at a dose of 0.4 mg/Kg up to maximum dose of 25 mg/dose SC twice weekly

1 drug, 2 placebo
PlaceboDRUG

administered at 0.4 mg/Kg/dose SC up to 25 mg max twice weekly

1 drug, 2 placebo

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and females subjects with T1DM aged 3-18 years
  • Positive GAD 65 and/or islet cell antibody
  • HbA1c at diagnosis above 6%
  • Insulin regimen with 3 injection of insulin daily (as described below)
  • White blood count between 3,000-10,000 and platelets \> 100,000
  • Normal ALT and AST, creatinine \< 1.8 mg/dl
  • T1DM duration equal or less than 4 weeks

You may not qualify if:

  • Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
  • BMI over 85th percentile for age and gender
  • Unstable household
  • Unable to provide compliance with study drug, insulin and study visits,
  • Evidence of psychiatric disease in the potential study subject and/or primary care taker
  • And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mastrandrea L, Yu J, Behrens T, Buchlis J, Albini C, Fourtner S, Quattrin T. Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind study. Diabetes Care. 2009 Jul;32(7):1244-9. doi: 10.2337/dc09-0054. Epub 2009 Apr 14.

    PMID: 19366957DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Teresa Quattrin, MD

    School of Medicine and Biochemical Sciences-SUNYAB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

October 1, 2002

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

April 28, 2023

Record last verified: 2023-04