1. Study population:It is applicable to male participants with genetically confirmed and clinically confirmed Duchenne muscular dystrophy (DMD), aged between 6 and 10 years. 2. Research period:The main research period of this clinical study is one year. Participants were tested during the baseline period and were followed up on days 0, 7, 14, 21, 60, 120, 200, and 360. 3. Exploratory indicators:MR Of both thighs, quantitatively calculating the muscle fat replacement indicators of the buttocks and proximal thighs;Patient Self-Rating Scale, Caregiver Self-Rating Scale. 4. Safety assessment:The safety assessment population will include all participants who have received the drug dose and have at least one post-drug safety assessment. Adverse events (AE) collected from the participants signed informed consent, all the way to the main study period at the end of the last follow-up. Safety laboratory evaluation, laboratory safety monitoring, including hematology, blood biochemistry, urine analysis (including troponin I, CK and CK - MB) and blood coagulation function, as well as complement. All common medication will be recorded. All adverse events, including abnormal complete blood cell count results, will be continuously tracked until they are resolved or stabilized. Only treatment-related adverse events (TEAE) will be summarized. AEs will be based on MedDRA and organ systems are recorded and archived. The classification and terminology related to AEs will be described according to the version of CTCAE v6.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Rituxan treatment
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);
Time frame: 1 year,
motor function assessment after using IP 200-day and 360-day
10-meter Run/Walk Time Test (TTRW) measured in meter;
Time frame: From enrollment to the end of trial at one year;
motor function assessment after using IP 200-day and 360-day
6-minute walk distance test (6MWT) measured in meter;
Time frame: 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;
Time frame: 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
Time frame: 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;
Time frame: 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;
Time frame: From enrollment to the end of trial at one year;
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