Trial · NCT06100744
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30) | Up to 24 Weeks | The JIA-ACR 30 response is defined as a \>= 30% improvement of at least 3 or more of the 6 juvenile idiopathic arthritis core response variables (JIA-CRVs) without \>30% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: physician global assessment of disease activity (PhGA), global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion high sensitivity C-reactive protein (hsCRP), and functional ability assessed by Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI). |
| Primary | Number of Participants with Adverse Events (AEs) | Up to Week 144 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
| Secondary | Percentage of Participants who Achieve >= 50% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 50) | Up to 24 Weeks | The JIA-ACR 50 response is defined as a \>= 50% improvement of at least 3 or more of the 6 JIA-CRVs without \>50% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. |
| Secondary | Percentage of Participants who Achieve >= 70% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 70) | Up to 24 Weeks | The JIA-ACR 70 response is defined as a \>= 70% improvement of at least 3 or more of the 6 JIA-CRVs without \>70% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. |
| Secondary | Percentage of Participants who Achieve >= 90% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 90) | Up to 24 Weeks | The JIA-ACR 90 response is defined as a \>= 90% improvement of at least 3 or more of the 6 JIA-CRVs without \>90% worsening in more than 1 of the remaining JIA-CRVs compared with Baseline. The 6 JIA-CRVs are: PhGA, parent/patient global assessment of overall well being, no of joints with active arthritis, no of joints with limitation of motion hsCRP, and functional ability assessed using the disability index of the CHAQ-DI. |
| Secondary | Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-10 | Up to Week 24 | JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and high sensitivity C-reactive protein (hsCRP). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. |
| Secondary | Change from Baseline in JADAS-27 | Up to Week 24 | JADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both), and hsCRP. JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles. |
| Secondary | Percentage of Participants with Achievement of Minimal Disease Activity (MDA) | Week 24 | MDA is defined as JADAS-10 of \<= 6. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. |
| Secondary | Percentage of Participants with Inactive Disease | Week 24 | Inactive disease is defined as JADAS-10 of \<= 2.7. JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. |
| Secondary | Change from Baseline in Clinical Juvenile Arthritis Disease Activity Score (cJADAS)-10 | Up to Week 24 | cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-10 is based on the count of any involved joint, up to a maximum of ten joints. |
| Secondary | Change from Baseline in cJADAS-27 | Up to Week 24 | cJADAS is a composite score of physician global assessment of disease activity, parent/patient global assessment of overall well-being, and number of joints with active arthritis (swelling not due to deformity, or limitation of motion with pain, tenderness or both). JADAS-27 includes a count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), and proximal interphalangeal joints, hips, knees, and ankles. |
| Secondary | Change from Baseline in the Pain-Visual Analogue Scale (VAS) | Week 24 | Participants assessed their pain using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 with no pain being indicated by 0 and severe pain by 100. |
| Secondary | Percentage of Participants with Psoriasis (PsO) who Achieve Psoriasis Area Severity Index (PASI) 75 in Participants with at least 3% Body Surface Area (BSA) at Baseline | Up to Week 24 | The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease. |
| Secondary | Percentage of Participants with PsO who Achieve PASI 90 in Participants with at least 3% BSA at Baseline | Up to Week 24 | The PASI is a measure of psoriasis severity. Four anatomic sites - head, upper extremities, trunk, and lower extremities - are assessed for erythema, induration and desquamation using a 5-point scale, with a lower score indicating more mild disease. |
| Secondary | Percentage of Participants with PsO who Achieve Static Physician Global Assessment of Disease Activity (sPGA) of PsO of 'Clear' (0) or Almost Clear (1) in Participants with at least 3% BSA at Baseline | Up to Week 24 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions, with a lower score indicating less body coverage. |
| Secondary | Percentage of Participants with PsO who Achieve change from Baseline in Children's Dermatology Life Quality Index (CDLQI) in Participants with at least 3% BSA at Baseline | Up to Week 24 | The CDLQI is a 10-item questionnaire used to assess the impact of dermatologic disease symptoms and treatment on quality-of-life (QOL), with a higher score indicating greater impairment of QOL. The CDLQI has been validated for use in participants 4 to 16 years old. |
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.
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