Long-term safety of Gamifant in people with macrophage activation syndrome in Still's disease

Who can take part

• Has received at least 1 dose of Gamifant 0-7 days prior to ICF date or is prescribed to initiate Gamifant
• Aged ≤80 years at index Gamifant administration
• Diagnosis of secondary HLH/MAS according to the treating physician
• Diagnosis or suspicion of Still's disease (sJIA or AOSD) according to the treating physician
• Patients who have shown inadequate response or intolerance to high-dose glucocorticoids or who have recurrent MAS, according to the treating physician. Recurrent MAS is defined as any MAS episode that has occurred after resolution of the first-ever MAS episode
• Patient agrees to provide relevant specimen (blood, sputum, and/or urine samples) for laboratory testing as outlined in the study protocol
• Informed consent must be obtained from the patient or the patient's legally authorized representative; For minors capable of providing assent (as determined by local regulations and the Investigator's judgment), informed assent must be obtained in accordance with applicable local regulations. If a minor is unable to provide assent due to age, developmental stage, or medical condition, the reason will be documented

Who cannot take part

• Concurrent participation in an interventional clinical trial
• Severe, uncontrolled concurrent illness at the index date likely to confound outcome assessment with expected survival <28 days based on investigator's assessment
• Diagnosis of pHLH or sHLH consequent to proven metabolic, malignancy, or a rheumatic disease other than Still's disease at index date
• Clinically active Mycobacterium tuberculosis (typical and atypical), Histoplasma capsulatum, or Salmonella infections at the index date based on investigator's assessment
• Evidence of leishmania infections at the index date based on investigator's assessment
• Pregnant at the time of study entry