Clinical Analysis of Juvenile Dermatomyositis Patients

Completed

• Conditions: Juvenile Dermatomyositis

• Registration Number: NCT05509140
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

This study aimed to investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis.

Detailed Description

Reviewed the clinical data of 12 juvenile dermatomyositis patients, from January 2014 to January 2017, hospitalized and treated with intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-08
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-18
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. patients with age of JDM onset <16 years
2. newly treated cases
3. no contraindications to corticosteroids
4. provide signed informed consent form
5. regular follow-up for more than 30 months.

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Exclusion Criteria

1. patients with serious complications of heart, liver and kidney
2. patients with a history of contraindications and/or allergies to GC
3. patients who underwent treatment before admission
4. patients who failed to regularly follow-up
5. patients with positive anti-melanoma differentiation-associated gene 5 (MDA5) antibodies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in CMAS score	1, 3, 6, 12, 18, 24 and 36 months	CMAS score is an index to assess the disease activity of JDM

Secondary Outcome Measures

Name	Time	Method
triglycerides	1, 3, 6, 12, 18, 24 and 36months	the patient's triglycerides is one of safety evaluation indicators.
Changes from baseline of the patient's height percentile in the same age and sex crowd.	1, 3, 6, 12, 18, 24 and 36months	the patient's height percentile in the same age and sex crowd is one of safety evaluation indicators.
Changes from baseline of the patient's weight percentile in the same age and sex crowd.	1, 3, 6, 12, 18, 24 and 36months	the patient's weight percentile in the same age and sex crowd is one of safety evaluation indicators.
intraocular pressure	1, 3, 6, 12, 18, 24 and 36months	the patient's intraocular pressure is one of safety evaluation indicators.