Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple System Atrophy | Drug: Rituximab | Phase 2 |
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 |
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.
|
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Tracking Information | |||||||
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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 |
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
|
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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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. Primary Purpose: Treatment |
||||||
Condition ICMJE | Multiple System Atrophy | ||||||
Intervention ICMJE | Drug: Rituximab
A lower dosage of rituximab for multiple system atrophy
|
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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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 |
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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 |