Trial · NCT05524311
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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 |
| Secondary | Dose of corticosteroid | At week 24 | Dose tapering at 6 months |
| Secondary | Pharmacokinetics study | At weeks 4, 8, 12, and 24 | Non-compartmental analysis of baricitinib |
| Secondary | Pharmacokinetics (PK) study with area under the curve | At weeks 4, 8, 12, and 24 | Correlation between area under the curve AUC in ng.h/ml (PK parameter of baricitinib) and disease activity 's scores |
| Secondary | Pharmacokinetics (PK) study with maximal concentration | At weeks 4, 8, 12, and 24 | Correlation between maximal concentration Cmax in ng/mL (PK parameter of baricitinib) and disease activity 's scores |
| Secondary | Pharmacokinetics (PK) study with through concentration | At weeks 4, 8, 12, and 24 | Correlation between through concentration Ctrough, in ng/mL (PK parameter of baricitinib) and disease activity 's scores |
| Secondary | dosage of cytokines | At inclusion, weeks 4 and 24 | Measurement of serum IFN -, IFN-γ, IL-1β, IL-4, Il-5, IL-6, IL-8, IL-10, IL-12p70, IL-22, TNF α |
| Secondary | transcriptomic analysis | At inclusion, weeks 4 and 24 | Study of genes expression within 800 genes related to immunity |
| Secondary | Biopsy | At inclusion, weeks 4 and 24 | Assessment of muscle biopsies according to the internationally validated score system |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05524311/registered