NCT02846545已完成2 期
SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1: Golimumab
Experimental
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).
干预措施: Golimumab (Biological)
Group 2: Placebo
Placebo Comparator
Participants will receive a matching placebo to golimumab.
干预措施: Placebo (Biological)
结局指标
主要结局
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
时间窗: Week 52
MMTT-Stimulated 4-Hour C-peptide AUC was defined as 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.
次要结局
- Hypoglycemic Event Rates(Up to Week 52)
- Titers of Antibodies to Golimumab(Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period))
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability(Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period))
- Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day(Baseline and Week 52)
- Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52(Baseline and Week 52)
- Serum Golimumab Concentrations(Preinjection: Week 0, Week 2, Week 4, Week 8, Week 12, and Week 26, Week 33, Week 38 (preinjection),Week 45 and Week 52 (preinjection), for active treatment period; Weeks 78 and 104 for Off-therapy follow-up period)
- Percentage of Participants With Severe Infections Through Week 52 and Week 104(Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period))
- Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time(Baseline, Weeks 12, 26, 38, 52, 78 and 104)
- Percentage of Participants With Serious Adverse Events(Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period))
- Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52(Up to Week 52)
- Number of Participants With Antibodies to Golimumab(Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period))
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