Clinical Trial Details

NCT ID: NCT02846545
Date Last Changed: September 5, 2017

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetes Mellitus, Type 1

Research Study Title

SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes

Purpose

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).

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
6 to 21 Years
Overall Status
Recruiting
Lead Sponsor
Janssen Research & Development, LLC
Duration
30 Months
Facility Type
N/A
Compensation

Eligibility

All ages 6 Years to 21 Years

Inclusion Criteria:

  • Be positive for at least 1 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase (GAD-65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin (if obtained within 10 days of the onset of exogenous insulin therapy)

  • Have a peak stimulated C-peptide level greater than or equal to ( > =) 0.2 picomole per milliliter (pmol/mL) following a 4-hour Mixed-meal Tolerance Test (MMTT) obtained at study screening

  • Be medically stable on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population

  • Females of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and a negative urine pregnancy test at the Week 0 visit

  • Participants (or their legally acceptable representatives) are willing and able to adhere to requirements, prohibitions, and restrictions specified in this protocol

Exclusion Criteria:

  • Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease or immune suppression or immune deficiency.

  • Has significant cardiovascular disease, including history of myocardial infarction, congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test

  • Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example [eg.], bronchiectasis), sinusitis, recurrent urinary tract infection (eg., recurrent pyelonephritis, chronic cystitis), Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer

  • Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV viral load

=10,000 copies per milliliter (mL) of plasma obtained at study screening. Has a clinically active infection with cytomegalovirus (CMV) or a CMV viral load > = 10,000 copies per milliliter (mL) of plasma obtained at study screening

  • Current or prior (within 30 days of screening) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high-dose inhaled, extensive topical, or systemic glucocorticoids

  • Has another autoimmune disease (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], multiple sclerosis [MS], systemic lupus erythematosus [SLE], celiac disease [clinically symptomatic and antibody positive, that is, tissue transglutaminase Immunoglobulin A [IgA]) excluding clinically stable autoimmune thyroiditis whether treated or untreated

  • Has any of the following tuberculosis [TB] screening criteria: A history of latent or active TB prior to screening (including but not limited to a positive QuantiFERON®-TB Gold test), signs or symptoms suggestive of active TB upon medical history and/or physical examination, recent close contact with a person with known or suspected active TB

  • Has known allergies, intolerance and/or hypersensitivity to human immunoglobulin proteins, golimumab or any of its components or its excipients

Site Locations (30)

Country State City Zip Facility and Contact
United States Arkansas Little Rock 72202 Arkansas Children's Research Institute
United States California Sacramento 95821 Sutter Institute for Medical Research
United States California San Diego 92123 Rady Children's Hospital
United States California San Francisco 94143 University Of California
United States California Walnut Creek 94598 Diablo Clinical Research, Inc.
United States Colorado Aurora 80045 University of Colorado
United States Florida Gainesville 32610 University of Florida
United States Georgia Atlanta 30318 Atlanta Diabetes Associates
United States Georgia Atlanta 30322 Emory University School of Medicine
United States Georgia Columbus 31904 Columbus Regional Research Institute
United States Idaho Boise 83712 St Luke's Hospital
United States Illinois Chicago 60637 University of Chicago
United States Indiana Indianapolis 46202 Indiana University
United States Kentucky Lexington 40503 Kentucky Diabetes Endocrinology Center
United States Kentucky Louisville 40202 University of Louisville
United States Louisiana Baton Rouge 70808 Pennington Biomedical Research Center
United States Maryland Baltimore 21229 Barry J Reiner, MD, LLC
United States Massachusetts Boston 02215 Joslin Diabetes Center
United States Massachusetts Worcester 1655 Univeristy of Massachusetts
United States New Jersey Morristown 07962 Goryeb Children's Hospital at Morristown Medical Center
United States New York Buffalo 14203 UBMD Pediatrics
United States New York The Bronx 10467 Children's Hospital at Montefiore
United States Ohio Mentor 44060 Your Diabetes Endocrine Nutrition Group, Inc
United States Pennsylvania Philadelphia 19104 Childrens Hospital Of Philadelphia
United States South Dakota Sioux Falls 57104 Sanford Health
United States Texas Dallas 75231 Research Institute of Dallas
United States Texas San Antonio 78229 Univ. Of Tx Health Science Center At San Antonio
United States Texas Schertz 78154 Northeast Clinical Research of San Antonio, LLC
United States Washington Seattle 98101 Benaroya Research Institute
United States Washington Tacoma 98405 MultiCare Health System

Contact

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

E-mail:

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