Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no Clinical Response After B-lymphocyte Depletion Using the Anti-CD20 Antibody Rituximab.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
研究概览
简要总结
The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME)
- •moderate and serious CFS/ME severity
- •age 18-66 years
- •informed consent
排除标准
- •patients with fatigue, not fulfilling criteria for CFS
- •pregnancy or lactation
- •previous malignant disease, except basal cell carcinoma of skin and cervical carcinoma in situ
- •previous long-term systemic treatment with immunosuppressive drugs such as cyclosporine, azathioprin, mycophenolate mofetil, except steroids e.g. in obstructive lunge disease.
- •demyelinating disease, such as multiple sclerosis.
- •heart failure.
- •endogenous depression.
- •lack of ability to comply to the protocol.
- •multi-allergy with risk of serious drug reaction
- •reduced renal function (creatinine > 1.5 x UNL)
- •reduced liver function (bilirubin or transaminases > 1.5 x UNL)
- •HIV positivity. Evidence of clinically significant infection. Previous viral hepatitis with risk of reactivation. High risk of opportunistic infections. Latent tuberculosis must be treated before inclusion.
研究组 & 干预措施
Etanercept
干预措施: Etanercept (Drug)
结局指标
主要结局
Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes.
时间窗: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up.
The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.
次要结局
- Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.(At 3, 6, 9, 12 months after start of intervention.)