EUCTR2017-002511-34-GB进行中（未招募）1 期
Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP - OPTIC Trial
Academic Medical Centre, Amsterdam,0 个研究点目标入组 96 人开始时间: 2019年11月8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
- 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
- •1) Probable or definite CIDP according to the EFNS/PNS criteria 2010 (all CIDP phenotypes).
- •2) Age = 18 years.
- •3a) Treatment naïve patients (no previous immune treatment for CIDP); or
- •3b) Previously immune-treated patients who have a relapse after a remission of at least 1 year; or
- •3c) Patients treated with subjective or objective improvement after a single loading course of IVIg in the last 3 months, and subsequent deterioration as judged by their treating physician.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 or low dose prednisolone (20 mg or less) during a short period (maximum 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 (glomerular filtration rate < 30 ml/min).
- •6) History of osteoporosis or osteoporotic fractures.
- •7) Known active malignancy, currently treated with chemotherapy or immunomodulatory drugs, or with a life 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 (from menarche until 1 year after the last period, surgical menopause or sterilization procedure) either not using or not willing to use a medically reliable method of contraception for the entire duration of the study.
- •10) Known cataract or cataract obvious on fundoscopy.
- •11) Current psychosis or past history of psychosis.
- •12) Poor dental status.
- •13) Known pulmonary embolism or other deep venous thrombosis in patient’s medical history, without current anticoagulant therapy.
- •14) Patient lacking capacity to consent to enter the trial.
- •15) Lack of written informed consent
研究者
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