The Effect of Rituximab on Cognitive and Hand Functions in Secondary Progressive Multiple Sclerosis: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test
研究概览
简要总结
The goal of this clinical trial is to know if rituximab can improve cognitive and hand functions in secondary progressive multiple sclerosis (SPMS) patients with high disability (EDSS 6.5 or more). The main questions it aims to answer are:
Can rituximab improve cognitive and hand functions in SPMS patients? Can rituximab improve the quality of life and the Expanded Disability Status Scale (EDSS) in SPMS patients?
Researchers will compare patients who receive rituximab to patient who receive placebo to see the effects of rituximab on cognition, hand functions, quality of life and EDSS.
Demographic and clinical data as age, gender, disease duration and EDSS will be obtained from each participant. Participants will perform The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), The Nine-Hole Peg Test (9-HPT) and The MS-QLQ27 questionnaire at baseline and after one year of receiving either rituximab or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of secondary progressive multiple sclerosis by Lorscheider et al's criteria (disability progression by 1 EDSS step in patients with EDSS ≤ 5.5 or 0.5 EDSS step in patients with EDSS ≥ 6 in the absence of a relapse, a minimum EDSS score of 4 and pyramidal functional system (FS) score of 2 and confirmed progression over ≥3 months, including confirmation within the leading FS).
- •Baseline EDSS ≥ 6.5.
排除标准
- •Patients received disease modifying therapy for SPMS other than rituximab.
- •Clinical relapse in the last 3 months before recruitment.
- •Patients with documented hypersensitivity or contraindication to rituximab.
- •Patients with concomitant neurologic conditions that may affect cognitive or hand functions.
研究组 & 干预措施
Control
This group will receive 500 ml normal saline 0.9% as intravenous infusions. Another dose will be given after 6 months
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
Intervention
This group will receive Rituximab as follows: initial 1gm divided into 2 doses (500 mg each) given 2 weeks apart then another 1gm will be given after 6 months. Vials will be diluted on 500 ml normal saline 0.9% and will be given as intravenous infusions.
干预措施: Rituximab (Drug)
结局指标
主要结局
The effect of rituximab on cognitive functions assessed by The Symbol Digit Modalities Test
时间窗: One year
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to identify the digit associated with each symbol as rapidly as possible for 90 seconds. The outcome measure is the number of correct responses over the 90 seconds time span.
The effect of rituximab on cognitive functions assessed by The Brief Visuospatial Memory Test-Revised
时间窗: One year
The Brief Visuospatial Memory Test-Revised (BVMT-R) constitutes of six abstract designs presented to the patient for 10 seconds. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12. There are three learning trials. The outcome measure is the total number of points earned over the three trials.
The effect of rituximab on cognitive functions assessed by The California Verbal Learning Test-II
时间窗: One year
The California Verbal Learning Test-II (CVLT-II) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible. After recall is recorded, the entire list is read again followed by a second attempt at recall. Altogether, there are five learning trials. The outcome measure is the total number of recalled items over the five trials.
The effect of rituximab on hand functions assessed by The Nine-Hole Peg Test
时间窗: One year
The Nine-Hole Peg Test (9-HPT) is a wood or plastic board with 9 holes (10 mm diameter, 15 mm depth) and a container. It is administered by asking the patient to take the pegs from a container, one by one, and place them into the holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The outcome measure is the time taken to complete the activity, recorded in seconds.
次要结局
- The effect of rituximab on quality of life(One year)
- The effect of rituximab on EDSS(One year)
研究者
Amgad Mahmoud Elmeligy
Assistant lecturer of Neurology
Cairo University