Clinical Analysis of Juvenile Dermatomyositis Patients

Juvenile Dermatomyositis Clinical Trial

Official title:

Clinical Analysis of 12 Cases of Juvenile Dermatomyositis Treated With Methylprednisolone Repeated Intermittent Pulse Combined With Mycophenolate Mofetil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509140
• Other study ID #: 2020-613
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Dermatomyositis
• Juvenile Dermatomyositis

Intervention

Other:
• observation
investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CMAS score	CMAS score is an index to assess the disease activity of JDM	1, 3, 6, 12, 18, 24 and 36 months
Secondary	Changes from baseline of the patient's height percentile in the same age and sex crowd.	the patient's height percentile in the same age and sex crowd is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months
Secondary	Changes from baseline of the patient's weight percentile in the same age and sex crowd.	the patient's weight percentile in the same age and sex crowd is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months
Secondary	intraocular pressure	the patient's intraocular pressure is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months
Secondary	triglycerides	the patient's triglycerides is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months