The 4th NextGen therapies for SJIA and MAS: part 3 clinical trials in refractory SJIA: historic controls as an alternative to a withdrawal design study

Group consensus: historical cohorts as a control group, to avoid a placebo arm or drug withdrawal, highly desirable and might be acceptable for clinical trials in MAS to support efficacy and safety

If historic controls are used, the historic cohort should match the study group in clinical characteristics (e.g. disease severity, exposure to other medications), and outcome in both groups should be assessed with the same outcome measures