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NCT06992505Completed

Assessment of Macrophage Activation syndromE in STill's Disease in Italy

Assessment of Macrophage Activation syndromE in STill's Disease: Retrospective Chart Analysis of Patient hIstory, Symptom Resolution and TreAtment Characteristics in Italy (AMETISTA)

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

Assessment of macrophage activation syndrome in Still's disease: retrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy

Status (registry)
Completed
Study type
Observational
Enrollment
32 (actual)
First submitted
9 May 2025
Start date
6 Jun 2025
Primary completion date
27 Nov 2025
Lead sponsor
Swedish Orphan Biovitrum
NCT number
NCT06992505

What you commit to

  • Study type: Observational
  • Participants enrolled: 32
  • From 6 Jun 2025 to the primary completion date, 27 Nov 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 6 months to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Ospedale Pediatrico Bambin Gesù
Coordinator of this site? Confirm its status
RomeItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.