Rituxan treatment
DrugRituxan treatment
NCT Number: NCT07475754
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.
Trial opening soon.
Get Notified6 year–10 year
Female
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rituxan treatment
Time frame: 1 year,
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: From enrollment to the end of trial at one year;
10-meter Run/Walk Time Test (TTRW) measured in meter;
Time frame: From enrollment to the end of trial at one year;
6-minute walk distance test (6MWT) measured in meter;
Time frame: From enrollment to the end of trial at one year;
Time to get up from a supine position measured in second;
Time frame: From enrollment to the end of trial at one year;
Time Test for Climbing Four Flights of Stairs (TTCLIMB) measured in second
Time frame: From enrollment to the end of trial at one year;
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;
Upper limb Function Test (PUL2.0 Scale) measured in Newton;
Contact information is provided by the study sponsor or research team.
Peking Union Medical College Hospital
Other
A Single-arm, Non-blind, Single-center Study to Evaluate the Safety and Tolerability of Rituximab Down-regulating Immunoglobulin (Ig) Treatment in Children With Duchenne Muscular Dystrophy (DMD) Who Can Walk
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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