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A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes (T1GER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02846545
First received: July 22, 2016
Last updated: March 21, 2017
Last verified: March 2017
  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).

Condition Intervention Phase
Diabetes Mellitus, Type 1
Biological: Golimumab
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 [ Time Frame: Baseline to Week 52 ]
    MMTT-Stimulated 4-Hour C-peptide AUC is the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.


Secondary Outcome Measures:
  • Change From Baseline in Insulin use in Units per Kilogram Body Weight per day [ Time Frame: Baseline to Weeks 26, 52 and 78 ]
  • Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Baseline to Weeks 26, 78 and 104 ]
  • Hypoglycemic Event Rates [ Time Frame: Week 0 up to Week 52, Week 52 to Week 104 and Week 0 up to Week 104 ]
    Defined as Blood Glucose Levels(BG) of Less Than or Equal to(=<) 70 Milligram per Deciliter(mg/dL) or Clinical Sequelae in the Absence of a BG Reading

  • C-peptide Area Under the Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time [ Time Frame: Baseline to Weeks 26, 78 and 104 ]
    MMTT-Stimulated 4-Hour C-peptide AUC is the mean area under the C-peptide level-time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Week 52 and Week 104 ]
  • Percentage of Participants With Severe Infections Through Weeks 52 and 104 [ Time Frame: Up to Week 52 and Week 104 ]
  • Percentage of Participants With Study Agent Injection Site Reactions Through Week 52 [ Time Frame: Up to Week 52 ]

Estimated Enrollment: 81
Actual Study Start Date: August 26, 2016
Estimated Study Completion Date: October 7, 2019
Estimated Primary Completion Date: September 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Golimumab
Participants will receive subcutaneous (SC) golimumab intermittently for 52 weeks, where doses will be based on weight and/or body surface area.
Biological: Golimumab
Participants will receive subcutaneous golimumab intermittently for 52 weeks, where doses will be based on weight and/or body surface area.
Other Name: SIMPONI
Placebo Comparator: Group 2: Placebo
Participants will receive a matching placebo to golimumab.
Biological: Placebo
Matching Placebo to golimumab

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 10^6 peripheral blood mononuclear cell (PBMCs) obtained at study screening. Has a clinically active infection with cytomegalovirus (CMV) or a CMV viral load >= 10,000 copies per milliliter (mL) whole blood 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 other autoimmune diseases (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], multiple sclerosis [MS], systemic lupus erythematosus [SLE]) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02846545

Contacts
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: JNJ.CT@sylogent.com

  Show 36 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02846545     History of Changes
Other Study ID Numbers: CR108187
CNTO148DML2001 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: July 22, 2016
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017