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Completed

NCT Number: NCT05509140

Clinical Analysis of Juvenile Dermatomyositis Patients

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.

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Key information

Conditions

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

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Change from baseline in CMAS score

    Time frame: 1, 3, 6, 12, 18, 24 and 36 months

    CMAS score is an index to assess the disease activity of JDM

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. intraocular pressure

    Time frame: 1, 3, 6, 12, 18, 24 and 36months

    the patient's intraocular pressure is one of safety evaluation indicators.

  4. triglycerides

    Time frame: 1, 3, 6, 12, 18, 24 and 36months

    the patient's triglycerides is one of safety evaluation indicators.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Aug 19, 2022
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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