Status:
COMPLETED
Assessment of Macrophage Activation syndromE in STill's Disease in Italy
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Macrophage Activation Syndrome (MAS)
Still Disease, Juvenile Onset
Eligibility:
All Genders
6-80 years
Brief Summary
Assessment of macrophage activation syndrome in Still's disease: retrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy
Detailed Description
This is an observational, retrospective cohort study on the treatment utilization and outcomes of Macrophage Activation Syndrome (MAS) refractory to glucocorticoids (GC) in patients with Still's disea...
Eligibility Criteria
Inclusion
- Age \>6 months and ≤80 years at the beginning of the index MAS episode.
- Diagnosis of Still's disease (sJIA or AOSD diagnosis).
- Diagnosis of MAS according to treating physician in the medical record.
- Patients who have received at least 3 consecutive days of GC after diagnosis of MAS and/or are judged by the Investigator to be refractory to GC due to clinical worsening of patient's condition.
- The onset of the index MAS episode occurred between 01 January 2012 and 30 September 2022.
- According to local regulations, waivers of consent will be sought for study participants from the appropriate regulatory authorities and/or the independent ethics committee (IEC)/institutional review board (IRB). o For patients not covered by waivers of consent, signed, and dated informed consent provided by the patient, or the patient's legally authorized representative(s) for patients under the legal age (with patient assent, as applicable) or who have died, should be obtained before any study-related activities are undertaken.
Exclusion
- A diagnosis of primary HLH prior to the beginning of the index MAS episode.
- Confirmed malignancy prior to the beginning of the index MAS episode.
- Patient treated with any investigational product as a part of clinical trial during the index MAS episode.
Key Trial Info
Start Date :
June 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 27 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06992505
Start Date
June 6 2025
End Date
November 27 2025
Last Update
December 2 2025
Active Locations (2)
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1
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
2
Ospedale Pediatrico Bambin Gesù
Rome, Italy, 00165