EUCTR2011-005606-30-GB进行中（未招募）1 期
Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge0 个研究点目标入组 32 人开始时间: 2012年4月2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
- 32
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
- •To be included in the trial the patient must have/be: • Male or non-pregnant, non-lactating female patients • Aged between 18 and 50 years inclusive • Diagnosis of MS using McDonald’s criteria, including diagnostic MRI • Onset of first MS symptoms within 10 years • EDSS score 0.0 to 5.0 (inclusive) at screening • At least 2 clinical episodes of MS in the 2 years prior to study entry, with at least 1 attack within 12 months, which may have occurred whilst on disease-modifying therapy, such as beta interferon therapy or glatiramer acetate. • Serum IL-21 =230pg/mL. Apart from the IL-21 inclusion criterion, the details of patient selection are identical to those adopted in the phase 3 trials of alemtuzumab (CARE MS1 and MS2). This ensures that the results of this trial can be generalised to these patient groups.
- •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 86
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The presence of any of the following will preclude patient inclusion: •Any progressive form of multiple sclerosis •Previous thymectomy •Previous treatment with alemtuzumab, mitoxantrone, cyclophosphomide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) •History of malignancy •Personal history of clinically significant autoimmune disease, other than multiple sclerosis (including but not limited to: thyroid disease, immune cytopenias, inflammatory bowel disease, diabetes, lupus, severe asthma) •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis •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. •Seropositivity for human immunodeficiency virus (HIV) •Past or present hepatitis B infection (positive hepatitis B serology) •Pregnant women or male and female patients who do not agree to use effective contraception during the study. Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal based contraception, surgical sterilisation, abstinence, or double barrier contraception i.e. condom and occlusive cap (diaphragm or cervical cap with spermicide). • Medical, psychiatric, cognitive or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
研究者
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