NL-OMON50340暂停3 期
Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP (OPTIC trial) - OPTIC trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •Deterioration after treatment is defined as any deterioration warranting
- •treatment as judged by the treating physician.
排除标准
- •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), 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 less than 30
- •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) Known pulmonary embolism or other deep venous thrombosis in patient*s
- •medical history, without current anticoagulant therapy
- •14) Legally incompetent adults
- •15) Lack of written informed consent
研究者
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