A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Golimumab; Placebo
Intervention description: 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.; Matching Placebo to golimumab.
Intervention MeSH terms: Golimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 6 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

        Double-blind Period:

          -  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

        Open-Label Extension Period:

        - Participants must meet the responder criteria based on C-peptide area under the
        concentration-time curve (AUC) and insulin dose-adjusted HbA1c (IDAAC) remission score

        Exclusion Criteria:

        Double-blind Period:

          -  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

        Open-Label Extension Period:

          -  Participants having reported clinically significant AEs or serious adverse events
             (SAEs) deemed to be related to the study agent during the double blind period (for
             example. severe infections or hypersensitivity reactions), precluding renewed exposure
             to golimumab

          -  Participants who discontinued study agent administration prior to Week 52 or who have
             completed the Week 104 visit of the double-blind period or discontinued early from
             study