EUCTR2014-001323-76-SE进行中（未招募）1 期
Open Label trial to evaluate the tolerability of a combination therapy consisting of GAD-alum (Diamyd®), etanercept and vitamin D in children and adolescents newly diagnosed with type 1 diabetes - EDCR (Etanercept Diamyd Combination Regimen)
inköping University0 个研究点目标入组 20 人开始时间: 2014年6月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •1.Informed consent given by patients and parent(s)/legal guardian(s)
- •2.Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening
- •3.Age 8.00 -17.99 years at time of screening
- •4.Fasting C-peptide at time of screening =0.12 nmol/l
- •5.Positive for GADA but < 50 000 Units
- •6.Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test
- •7.Immunity against Varicella, either through previous infection or vaccination
- •8.Patients must follow the Swedish vaccination programme
- •9.Patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of GAD-alum and etanercept. Adequate contraception is as follows:
- •For females of childbearing potential:
- •a.oral (except low-dose gestagen (lynestrenol and norestisteron), injectable, or implanted hormonal contraceptives (females)
- •b.intrauterine device (females)
- •c.intrauterine system (for example, progestin-releasing coil) (females)
- •d.vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
- •For males of childbearing potential:
- •a.Condom (male)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- •2.Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- •3.Treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin
- •4.Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial
- •5.A history of hypercalcemia
- •6.A history of anaemia or significantly abnormal haematology results at screening
- •7.A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles
- •8.Clinically significant history of acute reaction to vaccines or other drugs in the past
- •9.Treatment with any vaccine within 4 months prior to planned first administration of GAD-Alum or planned treatment with vaccine up to 4 months after the last injection with GAD-Alum, including influenza vaccine
- •10.Participation in other clinical trials with a new chemical entity within the previous 3 months
- •11.Inability or unwillingness to comply with the provisions of this protocol
- •12.A history of alcohol or drug abuse
- •13.A significant illness other than diabetes within 2 weeks prior to first dosing
- •14.Known human immunodeficiency virus (HIV)
- •15.Prior or active viral hepatitis B or C infection
- •16.Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine ßHCG on-site within 24 hours prior to the GAD-Alum and etanercept administration, respectively)
- •17.Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-Alum and etanercept administration, respectively
- •18.Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.
- •19.Deemed by the investigator not being able to follow instructions and/or follow the study protocol
- •20.Active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active EBV or CMV
- •21.Hypersensivity to the active substance in Enbrel (etanercept) or other ingredients in Enbrel
- •22.Active or inactive (latent) tuberculosis (TBC) at screening
- •23.History of malignancy or significant cardiovascular disease
- •24.Current or history of leukopenia, anemia and/or thrombocytopeni
- •25.Liver disease (clinical or hepatic enzymes >3 times the upper limit of normal (ULN))
- •26.Renal insufficiency (clinical or creatinine >3 times the upper limit of normal (ULN))
- •27.MS, undefined neurologic condition or known SLE, or anti-nuclear or known double-stranded DNA antibody positivity
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