Juvenile DermatomyositisNCT05509140
Clinical Analysis of Juvenile Dermatomyositis Patients
An observational study of Juvenile Dermatomyositis, run by The First Hospital of Jilin University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Juvenile Dermatomyositis
- What is being tested?
- observation
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients who meet the inclusion and exclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Juvenile Dermatomyositis
- Being tested
- observation
- Keywords
- intravenous methylprednisolone repeated intermittent pulse, mycophenolate mofetil
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CMAS score
CMAS score is an index to assess the disease activity of JDM
Measured: 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.
the patient's height percentile in the same age and sex crowd is one of safety evaluation indicators.
Measured: 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.
Measured: 1, 3, 6, 12, 18, 24 and 36months
intraocular pressure
the patient's intraocular pressure is one of safety evaluation indicators.
Measured: 1, 3, 6, 12, 18, 24 and 36months
triglycerides
the patient's triglycerides is one of safety evaluation indicators.
Measured: 1, 3, 6, 12, 18, 24 and 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile DermatomyositisStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SiRui Yang, The First Hospital of Jilin University
- Investigators
- Sirui Yang, doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509140
- Sponsor's protocol ID
- 2020-613
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of 12 Cases of Juvenile Dermatomyositis Treated With Methylprednisolone Repeated Intermittent Pulse Combined With Mycophenolate Mofetil
- ClinicalTrials.gov ID
- NCT05509140
- Acronym / sponsor ID
- 2020-613
- Conditions
- Juvenile Dermatomyositis
- Keywords
- intravenous methylprednisolone repeated intermittent pulse, mycophenolate mofetil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients who meet the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationinvestigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis | Other | – |
Primary outcome
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
4 secondary outcomes
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
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
intraocular pressure
Time frame: 1, 3, 6, 12, 18, 24 and 36months
triglycerides
Time frame: 1, 3, 6, 12, 18, 24 and 36months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirui Yang, doctor principal investigator
The First Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Dermatomyositis, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in CMAS score (time frame: 1, 3, 6, 12, 18, 24 and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.