Observational Study on Immunoadsorption (IA) in Patients With Autoantibody-Positive Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
研究概览
简要总结
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe, often infection-triggered disease characterized by debilitating fatigue and post-exertional malaise lasting over 14 hours, along with pain, cognitive impairment, autonomic dysfunction, and sleep disturbances. Around 10% of patients after mild or moderate COVID-19 develop Post-COVID Syndrome (PCS), and some meet ME/CFS criteria after six months. No causal treatment exists for ME/CFS or PCS; current approaches are symptomatic and rehabilitative. Given the high and increasing number of affected patients, there is an urgent need for evidence-based, standardized therapies.
Immunoadsorption (IA) is an established treatment for several autoimmune diseases. The first study demonstrating successful IA use in PCS-associated ME/CFS was published by our group in 2024. Earlier proof-of-concept studies (2018, 2020) in infection-related ME/CFS also showed symptomatic improvement in most patients.
Hypothesis:
Antibody depletion through IA improves symptoms in the majority of patients with autoantibody-positive ME/CFS and is associated with altered memory B-cell profiles before treatment.
Objective:
To observe and document symptom progression in 50 ME/CFS or PCS patients undergoing IA, and to examine whether changes in memory B-cells before treatment are linked to therapeutic response.
The study is conducted as a non-interventional observational study. IA using the TheraSorb® column (Miltenyi) is performed within its approved clinical application.
详细描述
Patients presenting to our outpatient clinic who meet the Canadian Consensus Criteria (CCC) for ME/CFS and show detectable autoantibodies are offered IA as part of routine care. Those undergoing IA are invited to participate in this observational study. Post-COVID patients fulfilling the CCC are also eligible for IA and study inclusion.
IA is performed independently of the study at the Diamedikum Potsdam. The standard clinical schedule includes five outpatient sessions on days 1, 2, 4, 6, and 8. This procedure follows routine clinical practice and is not influenced by study participation.
At study inclusion, all patients undergo baseline assessments including routine laboratory tests, immunoglobulins, autoantibodies, and biomarkers, with a total of 50 ml of blood collected. Additional diagnostic workup is performed as clinically indicated. The diagnosis of ME/CFS is confirmed using the CCC.
Health status and symptom severity are documented using validated questionnaires: SF-36 (Physical Function subscale), work ability (past 12 months), weighted CCC symptom score, Chalder Fatigue Questionnaire, and Bell Disability Scale. These are completed monthly for 12 months after treatment. To reduce participant burden, questionnaires are mailed to patients for home completion.
Further clinical and laboratory assessments are conducted before IA and at 2- and 6-months post-treatment: i) Handgrip strength, ii) NASA Lean Test, and iii) Blood sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years who are able to give informed consent and have: i) ME/CFS diagnosed according to the CCC, with exertion intolerance and symptom worsening (post exertional malaise = PEM) lasting at least 14 hours and ii) Significant functional impairment with a Bell Disability Score < 60
- •Presence of autoantibodies (adrenergic or antineuronal antibodies)
- •Undergoing IA with the TheraSorb® column over 5 days
- •Written informed consent provided by the patient
- •Health insurance coverage
排除标准
- •Lack of willingness to store pseudonymized disease data as part of the study
- •Pregnancy
- •Presence of other conditions that prevent a definite ME/CFS diagnosis (e.g., heart failure, lung disease, severe depression, cancer)
- •Acute infection (COVID, HIV, hepatitis)
- •Severe fatigue disease with bedriddenness (Bell Disability Score < 30)
结局指标
主要结局
Improvement in Physical Function (PF) as measured by the Short Form 36 Health Survey Questionnaire (SF-36)
时间窗: 8 weeks after first IA
The SF-36 is an established and widely used health-related quality of life measure. The PF domain asks patients to report limitations on ten mobility activities, such as walking specified distances, carrying groceries, and bathing or dressing. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). An intra-patient change of 10 points in SF-36-PF from baseline to week four is considered clinically meaningful.
次要结局
- Improvement in ability to work in daily hours(before first IA; 3 and 6 months after last IA)
- Improvement in hand grip strength(8 weeks after first IA)
- Improvement in physical and mental fatigue as measured by the Chalder Fatigue Scale(8 weeks after first IA; 3 and 6 months after last IA)
- Improvement in symptoms of ME/CFS as measured by Canadian Consensus Criteria (CCC) Symptom Score(8 weeks after first IA; 3 and 6 months after last IA)
- Improvement in symptoms of autonomic dysfunction as measured by the Composite Autonomic Symptom Score (COMPASS-31)(8 weeks after first IA; 3 and 6 months after last IA)
- Decrease in ß2R autoantibodies and soluble biomarkers of disease(8 weeks after first IA)
- Correlation of treatment response with memory B-cells(8 weeks after first IA)
- Verification of tolerability(8 weeks after last IA)
研究者
Carmen Scheibenbogen
Director of the Institute for Medical Immunology (Prof. Dr. med.)
Charite University, Berlin, Germany