Clinical Analysis of Juvenile Dermatomyositis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Dermatomyositis
• Intervention / Treatment: Other: observation

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 Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the inclusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
intraocular pressure	the patient's intraocular pressure is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months
triglycerides	the patient's triglycerides is one of safety evaluation indicators.	1, 3, 6, 12, 18, 24 and 36months

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Sirui Yang, doctor, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: mycophenolate mofetil; intravenous methylprednisolone repeated intermittent pulse
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Polymyositis; Myositis; Dermatomyositis
• Other Study ID Numbers: 2020-613

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No