EUCTR2005-002305-23-GB进行中（未招募）1 期
A pilot study of combination monoclonal antibody treatment in early active relapsing-remitting multiple sclerosis using Campath-1H and its non-binding form, SM3. - SM3
R&D Addenbrookes Hospital0 个研究点目标入组 0 人开始时间: 2008年1月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Male or non-pregnant, non-lactating female patients, 18 to 50 years of age (inclusive)
- •Diagnosis of MS using McDonald’s criteria29, including diagnostic MRI
- •Onset of first MS symptoms within 6 years prior to screening
- •EDSS 30 score 0.0 to 6.0 (inclusive) at the screening visit
- •At least 3 clinical episodes of MS in the 2 years prior to study entry
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Detectable anti-Campath-1H antibodies
- •Personal history of clinically significant autoimmune disease (e.g., inflammatory bowel disease, diabetes, lupus, severe asthma)
- •History of thyroid carcinoma (previous thyroid adenoma is acceptable and is not to be considered an exclusion criterion)
- •History of malignancy (except for basal cell skin carcinoma in which situation the patient is eligible only if disease-free for ?5 years)
- •History of anaphylaxis following exposure to humanized monoclonal antibodies
- •Inability to undergo MRI with gadolinium administration (for the MRI sub-cohort)
- •Female patients with childbearing potential and a positive serum pregnancy test within 2 weeks prior to randomization. (NB: Pregnancy testing will be performed on each occasion.)
- •Male and female patients who do not agree to use effective contraceptive method(s) during the study
- •Major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results
- •Abnormal CD4 count or significantly abnormal thyroid function
- •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
研究者
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