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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituxan treatment in Duchenne Muscular Dystrophy | Other | Dosage form:injection,intravenous drip; Dosage:The dosage was calculated based on the body surface area. For the first and second administrations, 375mg/m2 BSA was used. For the third and fourth administrations, the dose was halved to 187.5mg/m2 BSA; Frequency of administration:administered intravenously for 4 weeks, once a week, for a total of 4 times; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituxan treatment | Drug | Rituxan treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (AEs); | The incidence of adverse events (AEs) will be classified according to version 6.0 of the General Terminology Standard for Adverse Events (CTCAE); | 1 year, |
| Measure | Description | Time Frame |
|---|---|---|
| motor function assessment after using IP 200-day and 360-day | 10-meter Run/Walk Time Test (TTRW) measured in meter; | From enrollment to the end of trial at one year; |
| motor function assessment after using IP 200-day and 360-day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Dai, Doctor | Contact | 010-69151360 | pumchdy@sina.com |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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6-minute walk distance test (6MWT) measured in meter;
| From enrollment to the end of trial at one year; |
| motor function assessment after using IP 200-day and 360-day | Time to get up from a supine position measured in second; | From enrollment to the end of trial at one year; |
| motor function assessment after using IP 200-day and 360-day | Time Test for Climbing Four Flights of Stairs (TTCLIMB) measured in second | From enrollment to the end of trial at one year; |
| motor function assessment after using IP 200-day and 360-day | Measure muscle strength (elbow extension, elbow flexion, knee extension and knee flexion) with a handheld dynamometer measured in Newton; | From enrollment to the end of trial at one year; |
| motor function assessment after using IP 200-day and 360-day | Upper limb Function Test (PUL2.0 Scale) measured in Newton; | From enrollment to the end of trial at one year; |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |