NCT00848692已完成2 期
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.
Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
研究概览
简要总结
Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.
The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •verified chronic fatigue syndrome (CDC-criteria)
- •age >18 and <60 years
- •informed consent
排除标准
- •pregnancy or lactation
- •previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
- •previous long-term use of immunosuppressive drugs
- •previous exposure to rituximab
- •endogenous depression
- •multi-allergy with risk of serious drug reaction
- •reduced renal function (creatinin > 1.2 x UNL)
- •reduced liver function (bilirubin or transaminases > 1.5 x UNL)
- •known HIV infection
- •signs of active viral infection by pretreatment investigations
研究组 & 干预措施
1
Experimental
Rituximab
干预措施: Rituximab (Drug)
2
Placebo Comparator
Placebo (saline)
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
时间窗: 3 months after intervention
次要结局
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes(2, 4, 6, 8, 10, 12 months after intervention)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)NCT02229942Haukeland University Hospital151
已完成
1 期
Rituximab in the Treatment of Graves' DiseaseGraves´ DiseaseThyroid Associated OphthalmopathyNCT00150111Odense University Hospital20
终止
2 期
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue SyndromeMyalgic EncephalomyelitisChronic Fatigue SyndromeNCT01156922Haukeland University Hospital8
已完成
2 期
B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue SyndromeMyalgic EncephalomyelitisChronic Fatigue SyndromeNCT01156909Haukeland University Hospital29
已完成
不适用
Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome PatientsMyalgic EncephalomyelitisChronic Fatigue SyndromeNCT04301609Vitae Health Innovation67