Safety and Efficacy of Rituximab in patients with juvenile dermatomyositis

Phase 2

Recruiting

• Conditions: M33.0; Juvenile dermatomyositis.; Juvenile dermatomyositis

• Registration Number: IRCT20231119060108N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

Exclusion Criteria

Presence of concomitant diseases and overlap syndrome
Contraindications for rituximab injection

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.