The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in pediatric and adult participants with Still's disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Experimental drug
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
RECRUITINGLegacy Emanuel Research Hosp Portland
Portland, Oregon, United States
RECRUITINGNovartis Investigative Site
Montreal, Quebec, Canada
RECRUITINGNumber of participants with clinical response based on one set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Time frame: Day 85
Number of participants with clinical response based on another set of response criteria
Established measure for efficacy of treatments in the rheumatologic conditions taking into account self-assessment, function and survival.
Time frame: Day 85
Response based on a biomarker level
To evaluate the efficacy of MAS825 in reducing clinical disease activity
Time frame: Baseline, Day 85
Change in physician assessment based on laboratory features of MAS825
To assess the effect of MAS825 on macrophage activation syndrome
Time frame: Baseline, 15 months
Change from baseline in Glucocorticoid (GC) dose
To evaluate the efficacy of MAS825 as a glucocorticoid-sparing agent
Time frame: Baseline, Day 85, Month 6, Month 12
Change from baseline in patient/parent assessment of physical function as assessed by Quality of Life instrument
To evaluate the efficacy of MAS825 in improving participant's quality of life
Time frame: Baseline, Day 85
Clinically inactive disease whilst on non-treatment dose corticosteroid at any time during the study
The number of participants with inactive disease will be assessed. Disease activity will be evaluated by the investigator based on physical examination and laboratory parameters. Inactive disease is defined according to protocol-specific criteria, which include clinical signs, laboratory values, and physician assessment.
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Novartis Investigative Site
Montreal, Quebec, Canada
RECRUITINGTime frame: 15 months