Trial · NCT03265132
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2. | Week 2 | ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. (ACR: American College of Rheumatology) 1. Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm). 2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm). 3. Number of joints with active arthritis. 4. Number of joints with limitation of motion. 5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ). 6. C-Reactive Protein (CRP) (mg/L). |
| Secondary | Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1. | Week 1 | ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2. | Week 2 | ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by \>30% from baseline. |
| Secondary | Proportion of Responders in Physician Global Assessment of Disease Activity. | Week 2 | Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being. | Week 2 | Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in Number of Joints With Active Arthritis. | Week 2 | Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in Number of Joints With Limitation of Motion. | Week 2 | Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ). | Week 2 | Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Responders in CRP (mg/L). | Week 2 | Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here. |
| Secondary | Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2. | Week 2 | Proportion of patients with absence of fever during the 7 days preceding Week 2. |
| Secondary | Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1. | Week 1 | Absence of fever during the 24 hours preceding week 1. |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity at Week 1. | Day 1 and Week 1 | Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1. |
| Secondary | Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1. | Day 1 and Week 1 | Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1. |
| Secondary | Change From Baseline in CRP. | Day 1 and Week 1 | Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L. |
| Secondary | Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response. | Week 12 | Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here. |
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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