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出境医 / 临床实验 / Rituximab for Multiple System Atrphy

Rituximab for Multiple System Atrphy

Study Description
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

Study Design
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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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rituximab for Multiple System Atrphy
Official Title  ICMJE Rituximab Therapy for the Patients With Multiple Syetem Atrophy
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Multiple System Atrophy
Intervention  ICMJE Drug: Rituximab
A lower dosage of rituximab for multiple system atrophy
Study Arms  ICMJE
  • 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
    Intervention: Drug: Rituximab
  • No Intervention: Control group
    Patients will receive usual care and drug use.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004819
Other Study ID Numbers  ICMJE MRCTA,ECFAHOFFMU[2019]142
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wan-Jin Chen, First Affiliated Hospital of Fujian Medical University
Study Sponsor  ICMJE First Affiliated Hospital of Fujian Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account First Affiliated Hospital of Fujian Medical University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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