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

Janssen Biologics BV0 个研究点开始时间: 2021年1月14日最近更新: 2021年4月5日

试验速览

暂无简介。

•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)
•- 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

•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).

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