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Rituximab for Multiple System Atrphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004819
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University

Brief Summary:
Neuroprotective or anti-inflammatory strategies are invaluable in multiple system atrophy (MSA) due to its rapid progression with fatal prognosis. We evaluated the efficacy of rituximab in patients with MSA-cerebellar type (MSA-C).

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental: Rituximab group Drug: Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused

Placebo Comparator: Control group Patients will receive usual care and drug use.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab Therapy for the Patients With Multiple Syetem Atrophy
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab group
Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused
Drug: Rituximab
A lower dosage of rituximab for multiple system atrophy

No Intervention: Control group
Patients will receive usual care and drug use.



Primary Outcome Measures :
  1. The rate of change from baseline to 12 months in total UMSARS I score [ Time Frame: up to 360 days ]
    TUMSARS, Unified Multiple System Atrophy Rating Scale,a functional score of symptoms and ability to undertake activities of daily living usually consisting of 12 questions (we omitted question 11 [sexual function] because the question was poorly designed for women). Each question was scored from 0 to 4, with a higher score indicating a lower functional status


Secondary Outcome Measures :
  1. Change in immunology function [ Time Frame: up to 360 days ]
    Use the flow cytometry to measure the change at baseline, 90,180, 360 days after drug use



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80 years
  • Patients with probable MSA-C or it's mimic (tropical spastic paraparesis)
  • Baseline unified MSA rating scale scores of 30 to 50
  • MMSE> 24
  • Disease duration < 5 years

Exclusion Criteria:

  • Anticipated survival of at least 3 years
  • Inability to undergo neuroimaging with Magnetic Resonance
  • Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
  • Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
  • Pregnancy
  • Malignancy (history of or active)
  • Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004819


Locations
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China, Fujian
Department of Neurology ,First Affiliated Hospital Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Ying Fu, MD, PhD    13920263588    fuying1995@163.com   
Principal Investigator: Wan-Jian Chen, MD,PhD         
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
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Responsible Party: Wan-Jin Chen, Neurology department, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04004819    
Other Study ID Numbers: MRCTA,ECFAHOFFMU[2019]142
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents