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Safety and Efficacy of Rituximab in patients with juvenile dermatomyositis

Safety and Efficacy of Rituximab in patients with juvenile dermatomyositis (JDM) who were admitted at Mofid children hospital

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231119060108N1
Enrollment
7
Registered
2024-01-15
Start date
2024-01-21
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile dermatomyositis. Juvenile dermatomyositis

Interventions

Intervention group: Patients based on Body Surface Area (BSA) treated with the appropriate dose of rituximab (575 mg/m2 in patients with BSA =1.5 m2 and 750 mg/m2 in patients with BSA>1.5 m2), Two dos

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 16 Years

Inclusion criteria

Inclusion criteria: Patient under 16 years old Patients with the diagnosis of dermatomyositis, which is confirmed based on the diagnosis criteria

Exclusion criteria

Exclusion criteria: Presence of concomitant diseases and overlap syndrome Contraindications for rituximab injection

Design outcomes

Primary

MeasureTime frame
Disease activity. Timepoint: At the beginning of the intervention (before the start of the intervention), one week, one month, two months, three months, six months and one year after rituximab injection. Method of measurement: Juvenile Dermatomyositis-Disease Activity Score questionnaire, questionnaire of characteristics and information of dermatomyositis patients.;Drug Side Effects. Timepoint: One week, one month, two months, three months, six months and one year after rituximab injection. Method of measurement: Questioning the patient and parents.

Secondary

MeasureTime frame
Daily activity and quality of life. Timepoint: Before starting the intervention, one month, two, three months, six months and one year after drug injection. Method of measurement: Juvenile Dermatomyositis-Disease Activity Score questionnaire, questionnaire of characteristics and information of dermatomyositis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPooneh Tabibi

Shahid Beheshti University of Medical Sciences

Tabibi_p@yahoo.com+98 21 2222 7021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026