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Completed

NCT Number: NCT06992505

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

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Key information

Conditions

Macrophage Activation Syndrome (MAS) Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Immunoproliferative Disorders Joint Diseases Lymphoproliferative Disorders Macrophage Activation Syndrome Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Still Disease, Juvenile Onset Still's Disease, Adult-Onset

Age range

6 month–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan, Italy

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About this study

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 disease. The study will be conducted entirely through medical chart abstraction; all data will be taken from the patient's medical record, with no additional assessments. The study will be conducted in Italy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: from 2012 to 2022 (data abdstraction period)

    defined as the survival time of patients from the index date

  2. Time to laboratory value normalization

    Time frame: up to 24 weeks

    defined as the time to normalization for key laboratory values

  3. Time to MAS laboratory remission

    Time frame: up to 24 weeks

    defined as the time from index date to the last date of normalization of key laboratory assessments

  4. Time to partial MAS laboratory remission

    Time frame: up to 24 weeks

    defined as the time from index date to the last date of normalization of at least 3 of the key laboratory assessments

  5. Time to tapering of GCs

    Time frame: from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose

    defined as the time from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose

  6. Number of recurrent MAS episodes

    Time frame: from hospital discharge or 26-weeks from the index date, whichever occurs later, until the end of study data collection]

    defined as the number of MAS episodes occurring any time after the end of the data collection period for the index MAS episode (hospital discharge or 26-weeks from the index date, whichever occurs later) until the end of study data collection

  7. Administration of organ support care

    Time frame: from the index date until either the hospital discharge or 26 weeks, whichever occurs later

    defined as the proportion of patients receiving hemodialysis, assisted ventilation, cardiac support, or inotropic drugs at any time from the index date until either the hospital discharge or 26 weeks, whichever occurs later

  8. Characteristics of MAS treatment

    Time frame: up to 24 weeks

    Concomitant medications

  9. Clinical signs

    Time frame: at index date and 8 weeks after index date (allowed time window 6 to 12 weeks)

    Patients experiencing MAS symptoms if present (documentation in free text)

Secondary outcomes

  1. Time to hospital discharge

    Time frame: up to 24 weeks

    defined as time from the index date to discharge from the hospital

  2. Time to intensive care unit (ICU) discharge

    Time frame: up to 24 weeks

    defined as time from index date to ICU discharge

  3. Normalization of key laboratory values

    Time frame: Week 8 after index date (allowed time window 6 to 12 weeks)

    Normalization of key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)

  4. MAS laboratory remission

    Time frame: at Week 8 after index date (allowed time window 6 to 12 weeks).

    Normalization of Key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks).

  5. Partial MAS laboratory remission

    Time frame: at Week 8 after index date (allowed time window 6 to 12 weeks)

    Normalization of at least 3 key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)

  6. Duration of Clinical Response

    Time frame: up to 24 weeks

    defined as the time (in days) from the date of first documented MAS laboratory remission until the date of first documented occurrence of a new MAS episode as per Investigator's assessment.

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Registry information

Official study title

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

Acronym: AMETISTA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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