Clinical Analysis of Juvenile Dermatomyositis Patients

NCT05509140 | Completed

• 1 other identifier: 2020-613
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Juvenile Dermatomyositis

Keywords

intravenous methylprednisolone repeated intermittent pulse; mycophenolate mofetil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes from baseline of the patient's height percentile in the same age and sex crowd.

  1, 3, 6, 12, 18, 24 and 36months

• Changes from baseline of the patient's weight percentile in the same age and sex crowd.

  1, 3, 6, 12, 18, 24 and 36months

• intraocular pressure

  1, 3, 6, 12, 18, 24 and 36months

• triglycerides

  1, 3, 6, 12, 18, 24 and 36months

Interventions

observation OTHER

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

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the inclusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Dermatomyositis

Interventions

Observation

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Sirui Yang, doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 19, 2022
• Study Start: January 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08