EUCTR2017-002511-34-NL进行中（未招募）1 期
Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial) - OPTIC trial
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
- 96
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
- •Inclusion of patients is based on the presence of active disease and fulfillment of the probable or definite
- •EFNS/PNS criteria for CIDP. All new and untreated adult patients are eligible for the study. In addition we will include CIDP patients, treated previously, who have a disease relapse after a remission of at least 1 year, and patients who have responded to their first course of IVIg in the last three months but deteriorated afterwards.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1)Presence of IgM paraproteinemia , anti-MAG antibodies or CIDP specific antibodies associated with poor treatment response to IVIg
- •2)Use of drugs associated with a demyelinating neuropathy
- •3)Use of any immunosuppressive or immunomodulatory drugs in previous 6 months (except for a single loading dose of IVIg within 3 months), with the exception of low dose prednisone (20 mg or less for the duration of two weeks).
- •4)Known serious adverse events with previous IVIg or corticosteroid treatment
- •5)One of more of the risk factors associated with increased risk of adverse events of IVIg or IVMP or conditions that could lead to unblinding of treatment (i.e. diabetes; IgA deficiency; gastric ulcers; psychosis; severe hypertension (180/110 mmHg or more on repeated measurements); hypocalcaemia (lower than 2.20 mmol/L, corrected for albumin); moderate or severe heart failure; severe cardiovascular disease (i.e. more than one myocardial infarction and or ischemic stroke); renal failure (glomerulal filtratrion rate < 30 ml/min)
- •6)History of osteoporosis or osteoporotic fractures
- •7)Known malignancy with survival expectancy of less than 1 year
- •8)Bodyweight more than 120 kg
- •9)Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study
- •10)Cataract
- •11)Psychosis
- •12)Poor dental status
- •13)Legally incompetent adults
- •14)Lack of written informed consent
研究者
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