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Clinical Analysis of Juvenile Dermatomyositis Patients

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Completed
CT.gov ID
NCT05509140
Collaborator
(none)
12
Enrollment
96
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
12 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Clinical Analysis of 12 Cases of Juvenile Dermatomyositis Treated With Methylprednisolone Repeated Intermittent Pulse Combined With Mycophenolate Mofetil
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in CMAS score [1, 3, 6, 12, 18, 24 and 36 months]

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

Secondary Outcome Measures

  1. Changes from baseline of the patient's height percentile in the same age and sex crowd. [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. [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 [1, 3, 6, 12, 18, 24 and 36months]

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

  4. triglycerides [1, 3, 6, 12, 18, 24 and 36months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Hospital of Jilin University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SiRui Yang, professor, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT05509140
Other Study ID Numbers:
  • 2020-613
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by SiRui Yang, professor, The First Hospital of Jilin University
intravenous methylprednisolone repeated intermittent pulse
mycophenolate mofetil
Additional relevant MeSH terms:
Dermatomyositis

Study Results

No Results Posted as of Aug 19, 2022