A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02846545
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — BIOLOGICAL
    Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.
  • Placebo — BIOLOGICAL
    Matching Placebo to golimumab.

Study Details

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Key Dates

Start date
Aug 26, 2016
Status verified
Jan 2025
Primary completion
May 21, 2019
Completion
Jan 5, 2021

Study Design

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

Arms

  • Experimental: Group 1: Golimumab
    Participants will receive subcutaneous (SC) golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may enter in an open-label (OL) extension period to receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area).
  • Placebo Comparator: Group 2: Placebo
    Participants will receive a matching placebo to golimumab.

Primary Outcome Measure

Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 [ Time Frame: Week 52 ]

Locations (33)

FacilityCityStateZIPSite coordinators
-Little RockArkansas--
-Newport BeachCalifornia--
-SacramentoCalifornia--
-San DiegoCalifornia--
-San FranciscoCalifornia--
-Walnut CreekCalifornia--
-AuroraColorado--
-New HavenConnecticut--
-DoralFlorida--
-GainesvilleFlorida--
-AtlantaGeorgia--
-ColumbusGeorgia--
-BoiseIdaho--
-ChicagoIllinois--
-IndianapolisIndiana--
-LexingtonKentucky--
-LouisvilleKentucky--
-Baton RougeLouisiana--
-BaltimoreMaryland--
-BostonMassachusetts--
-WorcesterMassachusetts--
-MorristownNew Jersey--
-BuffaloNew York--
-The BronxNew York--
-MentorOhio--
-PhiladelphiaPennsylvania--
-Sioux FallsSouth Dakota--
-DallasTexas--
-San AntonioTexas--
-SchertzTexas--
-WebsterTexas--
-SeattleWashington--
-TacomaWashington--

Find similar trials in Little Rock, AR

By condition
Type 1 diabetes
By specialty
Endocrinology

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