EUCTR2017-000225-12-FI进行中（未招募）1 期
A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Is male or female.
- •-Is 6 to 21 years of age, inclusive, with minimal weight of 30 kg.
- •-Is positive for at least 2 of the following diabetes-related autoantibodies obtained at study screening:
- •Glutamic acid decarboxylase-65 (GADA-65) Autoantibodies
- •Insulinoma-associated 2 Autoantibodies (IA-2A)
- •Zinc Transporter-8 (ZnT8)
- •Islet Cell Cytoplasmic Autoantibodies (ICA)
- •Insulin Autoantibodies (IAA)
- •Participants with a confirmed documented history of at leas 2 positive diabetes-related autoantibodies but who screen positive on only 1 autoantibody are considered to have met this inclusion criterion 3.
- •-Has a plasma glucose of 7.8 to 11.0 mmol/L (140 to 199 mg/dL) at the 120 minute timepoint of a 2h-OGTT, OR have a plasma glucose of >200 mg/dL (>11.1 mmol/L) at the 30, 60, or 90 minute timepoint of a 2h OGTT OR have a HbA1c =5.7% but <6.5% (=32 to <48 mmol/mol) evaluated at screening.
- •-Is medically stable on the basis of physical examination, medical history, laboratory results, and vital signs performed at screening. Any abnormalities must be consistent with the underlying pre-symptomatic stage of illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Has a current or prior diagnosis of diabetes mellitus (Type 1, Type 2, or gestational) or meet the metabolic criteria diagnostic of diabetes mellitus obtained at screening including: HbA1c =6.5% (48 mmol/mol), or Fasting plasma glucose =7.0 mmol/L (126 mg/dL) (fasting: no intake =8 hours), or Plasma glucose =11.1 mmol/L (200 mg/dL) 2 hours post OGTT, or Random plasma glucose =11.1 mmol/L (200 mg/dL) in those with symptoms consistent with hyperglycemia crisis. In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.
- •-Has a history of moderate or severe progressive or uncontrolled liver or renal insufficiency, significant cardiac (including congestive heart failure), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or psychiatric disease (such as serious depression, including suicidality).
- •-Has a presence or history of malignancy.
- •-Has a presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or clinically significant hepatomegaly or splenomegaly.
- •-Has an immune deficiency syndrome (eg, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia.
- •-Has other autoimmune diseases (eg, RA, pJIA, PsA, AS, multiple sclerosis, celiac disease, systemic lupus erythematosus) excluding clinically stable autoimmune thyroiditis whether treated or untreated.
- •-Has a concomitant diagnosis or history of demyelinating disease, such as but not limited to multiple sclerosis or Guillain-Barre Syndrome.
- •-Has known or suspected intolerance or hypersensitivity to human proteins, antibody fragments, or monoclonal antibodies, including golimumab or its excipients, or known allergies or severe sensitivity to latex (refer to the golimumab and VarioJect Investigator's Brochures).
研究者
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