Clinical Analysis of Juvenile Dermatomyositis Patients

August 18, 2022 updated by: SiRui Yang, The First Hospital of Jilin University

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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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