Macrophage Activation Syndrome (MAS) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD). Emapalumab is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in sJIA or AOSD participants developing MAS, presenting an inadequate response to high dose glucocorticoid treatment.
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Incidence, Severity, Causality, and Outcomes of AEs (Serious and Nonserious)
Timeframe: Up to Week 8
Evolution of Laboratory Parameters
Timeframe: Up to Week 8
Number of Participants Withdrawn Due to Safety Reasons
Timeframe: Up to Week 8
Number of Participants Achieving MAS Remission at Week 8 After Initiation of Emapalumab Treatment
Timeframe: Week 8
Time to First MAS Remission
Timeframe: Up to Week 8
Number of Participants for Whom Glucocorticoids Could be Permanently Tapered at Any Time During the Study
Timeframe: Up to Week 8
Time to Achievement of Permanent Glucocorticoids Tapering
Timeframe: Up to Week 8
Survival Time
Timeframe: Up to Week 8
Number of Participants Withdrawn From the Study Due to Lack of Efficacy
Timeframe: Up to Week 8
Levels of Emapalumab Concentration
Timeframe: Data from the following time points are presented: SD0 (pre- and post-dose), Week 4 Visit 2 (pre- and post-dose), and 4-week follow-up visit/EoS.
Pharmacodynamic Parameters
Timeframe: Up to Week 8
Number of Participants Who Demonstrated a Presence of Circulating Antibodies Against Emapalumab to Determine Immunogenicity
Timeframe: Up to Week 8