SIMPONI® to Arrest ß-cell Loss in Type 1 Diabetes MedDRA version: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Current Spons
Sponsors
Janssen Biologics BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 6 through 21 years of age 2. Be positive for at least 1 of the following diabetes-related autoantibodies obtained at study screening: - Glutamic acid decarboxylase (GAD-65) - IA-2 - ZnT8 - ICA; or - Insulin (if obtained within 10 days of the onset of exogenous insulin therapy) 3. Have a peak stimulated C-peptide level =0.2 pmol/mL following a 4-hour MMTT obtained at study screening. 4. 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. 5. Females of childbearing potential must have a negative serum B-human chorionic gonadotropin [B-hCG]) test at screening and a negative urine pregnancy test at the Week 0 visit. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease. 2. Has significant cardiovascular disease, including history of myocardial infarction, congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test. 3. Has a disease associated with lymphopenia, malignancy, bone marrow or organ transplantation, lymphoproliferative disorder, immune deficiency syndrome (eg, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease). 4. Has another autoimmune disease (eg, RA, pJIA, PsA, AS, MS, systemic lupus erythematosus [SLE], celiac disease [clinically symptomatic and antibody positive, ie, tissue transglutaminase IgA]). excluding clinically stable autoimmune thyroiditis whether treated or untreated. 5. Has nervous system disorder including but not limited to Guillain Barre Syndrome, multiple sclerosis (MS), or progressive multifocal leukoencephalopathy (PML).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if golimumab can preserve ß-cell function in children and young adults with newly diagnosed T1D.;Secondary Objective: -To evaluate the impact of golimumab on measures of diabetes control in this subject population. -To evaluate the off-therapy durability of golimumab on measures of diabetes control in this subject population. -To determine the safety and tolerability of golimumab in children and young adults with T1D. -To evaluate the PK and immunogenicity of golimumab in this specific subject population with T1D. ;Primary end point(s): The Mixed-meal Tolerance Test (MMTT) - stimulated 4-hour C-peptide area under the concentration-time curve (AUC) at Week 52.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change from baseline in insulin use in units per kilogram body weight per day over time. -Change from baseline in HbA1c over time. -Hypoglycemic event rates (defined as blood glucose levels (BG) of =70, 55, and 35 mg/dL or clinical sequelae in the absence of a BG reading) through Week 52, after Week 52 through Week 104, and the entire study. -MMTT-stimulated 4-hour C-peptide AUC over time. Proportion of subjects with treatmentemergent adverse events (AEs) and severe AEs through Week 52 and 104. -Proportion of subjects with severe infections through Week 52 and 104. -Proportion of subjects with study agent injection site reactions through Week 52. -Summary of serum golimumab concentrations and the PK profile after induction and maintenance dosing. -Incidence and titers of antibodies to golimumab.;Timepoint(s) of evaluation of this end point: Week 52 through Week 104 | — |
Countries
United States
Contacts
Public ContactClinical Registry Group
Janssen Biologics BV
Outcome results
None listed