Trial · NCT05524311
Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
NCT05524311, Phase 2, Completed, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT). Trials, record NCT05524311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05524311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)
- NCT number
- NCT05524311
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Juvenile Dermatomyositis
- Interventions
- Baricitinib, pharmacokinetics study, dosage of cytokines, transcriptomic analysis, Parent version of the Child Health Questionnaire (CHQ), Childhood Health Assessment Questionnaire, Pregnancy test
- First posted
- 2022-09-01
- Last updated
- 2026-04-23
- Other registries' IDs
- eudract:2022-000506-10
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PRINTO 20 (Paediatric Rheumatology INternational Trials Organisation scale) | At week 24 | Achievement of the validated juvenile dermatomyositis PRINTO 20 level of improvement. PRINTO 20 level of improvement is defined as a 20% or greater improvement in three or more of the six variables of the juvenile dermatomyositis core set, with one or no variable worsening by more than 30% (muscle strength can not be the variable worsening) : 1. muscle strength, assessed with the Childhood Myositis Assessment Scale (CMAS), 2. physician's global assessment of the patient's disease activity (Physician's VAS) 3. global disease activity assessment through the Disease Activity Score (DAS) 4. functional ability through the Childhood Health Assessment Questionnaire (C-HAQ) 5. parent's global assessment of the child's overall wellbeing (Parent's VAS) 6. health-related quality of life, through the parent version of the Child Health Questionnaire (CHQ-Phs) A higher score is 100% and means a better outcome, a lower score is 0% and means a worse result. |
| Secondary | PRINTO 20 Paediatric Rheumatology INternational Trials Organisation scale - level 20 | At week 4, 8, 12 and 16 | achievement of the validated juvenile dermatomyositis PRINTO 20 level ; reaching a minimum of 20 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result |
| Secondary | PRINTO 50 Paediatric Rheumatology INternational Trials Organisation scale - level 50 | At week 4, 8, 12 and 16 | achievement of the validated juvenile dermatomyositis PRINTO 50 level ; reaching a minimum of 50 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result |
| Secondary | PRINTO 70 Paediatric Rheumatology INternational Trials Organisation scale - level 70 | At week 4, 8, 12 and 16 | achievement of the validated juvenile dermatomyositis PRINTO 70 level ; reaching a minimum of 70 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result |
| Secondary | PRINTO 90 Paediatric Rheumatology INternational Trials Organisation scale - level 90 | At week 4, 8, 12 and 16 | achievement of the validated juvenile dermatomyositis PRINTO 90 level ; reaching a minimum of 90 % a higher score is 100% and mean a better outcome a lower score is 0% and means a worse result |
| Secondary | Total Improvement Score (TIS) | At inclusion, weeks 4, 8, 12, 16 and 24 | Relative and absolute variations of TIS. The TIS is the sum of the improvement in each of the six core set measures of disease activits The minimum score is 0 (worse) and maximum score is 100 (better) A major response is defined by a score \> 70 A moderate response is defined by a score \> 45 A minimal response is defined by a score \> 30 |
| Secondary | Clinically inactive disease | At weeks 4, 8, 12 and 24 | according to the PRINTO criteria |
| Secondary | Cutaneous Dermatomyositis Disease Area and Severity Index (CDSAI) | At inclusion, weeks 4, 8, 12, 16 and 24 | assess skin activity and damage across multiple body regions in patients with dermatomyositis |
| Secondary | Myositis Disease Activity Assessment VAS (MYOACT) | At inclusion, weeks 4, 8, 12, 16 and 24 | Assess Relative and absolute variations of extramuscular activity |
| Secondary | interstitial lung disease | At inclusion and at week 24 | Assessed by improvement of at least 10% of FCV, PTC, and DLCO and/or improvement of Lung tomodensitomery according to a specific scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05524311
GET https://conductscience.org/api/trials/v1/NCT05524311/registered