NL-OMON21678招募中不适用
Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
Amsterdam UMC, location AMC0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
研究概览
简要总结
Planned publication in a high-impact peer reviewed journal, with the intent to publish the results in one year following overall trial end date
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Probable or definite CIDP according to the EFNS/PNS criteria 2010 (all CIDP phenotypes)
- •2. Age = 18 years
- •3.1. Treatment naïve patients; or
- •3.2. Previously treated patients who have a relapse after a remission of at least 1 year; or
- •3.3. Patients treated with subjective or objective improvement after a single loading dose of IVIg in the last 3 months, and subsequent deterioration as judged by his or her treating physician.
排除标准
- •A potential patient who meets any of the following criteria will be excluded from participation in this study:
- •1)Presence of IgM paraproteinemia and/or 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. Hypersensitivity to methylprednisolone or any component of the formulation. Hypersensitivity to the human immunoglobulins or to any of the excipients. Selective IgA deficiency patients who developed antibodies to IgA.
- •5)Systemic fungal infections, unless specific anti-infective therapy is employed.
- •6)Known hyperprolinaemia type I or II or known fructose intolerance.
- •7)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)
- •8)History of osteoporosis or osteoporotic fractures
- •9)Known active malignancy, currently treated with chemotherapy or immunomodulatory drugs, or with a life expectancy of less than 1 year.
- •10)Bodyweight more than 120 kg
- •11)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. A woman is considered of childbearing potential from menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Acceptable methods of contraception are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (whether oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (whether oral, injectable or implantable), progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap or diaphragm, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success).
- •12)Known cataract or cataract obvious on fundoscopy
- •13)Current psychosis or past history of psychosis
- •14)Poor dental status
- •15)Known pulmonary embolism or other deep venous thrombosis in patient’s medical history, without current anticoagulant therapy
- •16)Adults lacking capacity to give informed consent.
- •17)Lack of written informed consent
研究者
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