DRKS00030948招募中2 期
B-cell depletion for the treatment of patients with amyotrophic lateral sclerosis (ALS) - A Randomized, Double-blind, Placebo controlled Pilot Study in Patients with Amyotrophic Lateral Sclerosis for the Evaluation of Efficacy and Safety of B-Cell Depletion with Rituximab (ABCD) - ABCD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Disease duration of sporadic ALS is = 24 months after symptom onset and symptoms have not progressed to a permanent need of assisted ventilation of any kind (including non-invasive ventilation).
- •Written consent to participate in the study
- •Patients with the capacity to give informed consent
- •The patient is capable to attend study visits
- •Medication with riluzole at a stable dose of 50 mg BID for = 30 days prior to the screening visit and if possible, throughout the study.
- •Slow vital capacity (VC) equal to or more than 75% of the predicted normal value for gender, height and age at the screening visit
- •Recommended vaccination according to STIKO (incl. COVID-19 vaccination)
排除标准
- •Dysfunction (other than ALS) that could distort or obscure the diagnosis of ALS
- •Patients with a tracheostomy or ongoing treatment (more than 7 consecutive days in the 4 weeks prior to the screening visit) requiring noninvasive positive pressure ventilation of any kind
- •Patients with HIV infections
- •Active, severe infections (e.g. tuberculosis, sepsis and opportunistic infections)
- •History of chronically active hepatitis including active or chronic hepatitis B, acute or chronic hepatitis C
- •History of a tuberculosis (TB) infection, signs/symptoms of TB or close contact with a person with an active TB infection
- •Clinically significant infection involving intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the screening visit
- •Patients with a serious impairment of the immune system
- •Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled heart disease
- •Patients having severe disease in the renal, cardiovascular or hematological system
- •Patients with neutrophils < 1000 cells per µl and/or platelet counts < 75.000 cells per µl
- •Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial or poses any added risk for the patient
- •Patients with other causes of neuromuscular weakness
- •Patients with severe active psychiatric illness
- •Patients with a diagnosis of another neurodegenerative disease (e.g. Parkinson disease, Alzheimer’s disease)
- •Participation in any other investigational drug study or exposure to an investigational drug within 5 half-lives of the study drug at baseline
- •Patients with a history of recurrent or chronic infections or with underlying diseases which may further predispose patients to serious infection
- •Sexually active male and female patients of reproductive potential (female patients / female partners of patients less than 12 months postmenopausal) who do not use highly effective contraception methods (pearl index <1) during and up to 12 months after treatment.
- •The patient has used edaravone or sodium phenylbutyrate–taurursodiol in the first week before the baseline visit
- •Hypersensitivity to the active substance, mouse proteins or sodium citrate, polysorbate 80
- •Known cytokine release syndrome after infusions
- •Hypersensitivity to the adjuvant medication (paracetamol and prednisolone)
- •Pregnancy or lactation
研究者
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