Macrophage Activation Syndrome (MAS)AMETISTANCT06992505
Assessment of Macrophage Activation syndromE in STill's Disease in Italy
An observational study of Macrophage Activation Syndrome (MAS) and Still Disease, Juvenile Onset, run by Swedish Orphan Biovitrum at 2 sites in Italy.
Trial summary
Assessment of macrophage activation syndrome in Still's disease: retrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Macrophage Activation Syndrome (MAS), Still Disease, Juvenile Onset, Still's Disease, Adult-Onset
- How many people
- 32 participants
- Where
- 2 sitesItaly
- Study dates
- 6 Jun 2025to 27 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include patients with Still's disease who were diagnosed with MAS that was refractory to GC treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Ospedale Pediatrico Bambin Gesù
Rome, 00165
About this study
Official title: Assessment of Macrophage Activation syndromE in STill's Disease: Retrospective Chart Analysis of Patient hIstory, Symptom Resolution and TreAtment Characteristics in Italy (AMETISTA)
Assessment of macrophage activation syndrome in Still's disease:
retrospective chart analysis of patient history, symptom resolution and treatment characteristics in Italy
Read the 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 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.
- Conditions
- Macrophage Activation Syndrome (MAS), Still Disease, Juvenile Onset, Still's Disease, Adult-Onset
- Medical subject headings
- Macrophage Activation Syndrome, Arthritis, Juvenile, Still's Disease, Adult-Onset
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
defined as the survival time of patients from the index date
Measured: from 2012 to 2022 (data abdstraction period)
Time to laboratory value normalization
defined as the time to normalization for key laboratory values
Measured: up to 24 weeks
Time to MAS laboratory remission
defined as the time from index date to the last date of normalization of key laboratory assessments
Measured: up to 24 weeks
Time to partial MAS laboratory remission
defined as the time from index date to the last date of normalization of at least 3 of the key laboratory assessments
Measured: up to 24 weeks
Time to tapering of GCs
defined as the time from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose
Measured: from index date to the last of 7 consecutive days receiving ≤1 mg/kg/day of prednisone (PDN) equivalent dose
Number of recurrent MAS episodes
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
Measured: from hospital discharge or 26-weeks from the index date, whichever occurs later, until the end of study data collection]
Administration of organ support care
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
Measured: from the index date until either the hospital discharge or 26 weeks, whichever occurs later
Characteristics of MAS treatment
Concomitant medications
Measured: up to 24 weeks
Clinical signs
Patients experiencing MAS symptoms if present (documentation in free text)
Measured: at index date and 8 weeks after index date (allowed time window 6 to 12 weeks)
Secondary outcomes (6)
Time to hospital discharge
defined as time from the index date to discharge from the hospital
Measured: up to 24 weeks
Time to intensive care unit (ICU) discharge
defined as time from index date to ICU discharge
Measured: up to 24 weeks
Normalization of key laboratory values
Normalization of key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)
Measured: Week 8 after index date (allowed time window 6 to 12 weeks)
MAS laboratory remission
Normalization of Key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks).
Measured: at Week 8 after index date (allowed time window 6 to 12 weeks).
Partial MAS laboratory remission
Normalization of at least 3 key laboratory values at Week 8 after index date (allowed time window 6 to 12 weeks)
Measured: at Week 8 after index date (allowed time window 6 to 12 weeks)
Duration of Clinical Response
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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start6 Jun 2025
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macrophage Activation Syndrome (MAS)Studies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06992505
- Sponsor's protocol ID
- Sobi.EMAPALUMAB-106
- Acronym
- AMETISTA
- Status last verified
- Nov 2025
- First submitted
- 9 May 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Macrophage Activation syndromE in STill's Disease: Retrospective Chart Analysis of Patient hIstory, Symptom Resolution and TreAtment Characteristics in Italy (AMETISTA)
- ClinicalTrials.gov ID
- NCT06992505
- Acronym / sponsor ID
- AMETISTA / Sobi.EMAPALUMAB-106
- Conditions
- Macrophage Activation Syndrome (MAS), Still Disease, Juvenile Onset, Still's Disease, Adult-Onset
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients with Still's disease who were diagnosed with MAS that was refractory to GC treatment.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: from 2012 to 2022 (data abdstraction period)
defined as the survival time of patients from the index date
Time to laboratory value normalization
Time frame: up to 24 weeks
defined as the time to normalization for key laboratory values
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
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
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
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
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
Characteristics of MAS treatment
Time frame: up to 24 weeks
Concomitant medications
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)
6 secondary outcomes
Time to hospital discharge
Time frame: up to 24 weeks
Time to intensive care unit (ICU) discharge
Time frame: up to 24 weeks
Normalization of key laboratory values
Time frame: Week 8 after index date (allowed time window 6 to 12 weeks)
MAS laboratory remission
Time frame: at Week 8 after index date (allowed time window 6 to 12 weeks).
Partial MAS laboratory remission
Time frame: at Week 8 after index date (allowed time window 6 to 12 weeks)
Duration of Clinical Response
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Related trials for Macrophage Activation Syndrome (MAS)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Not yet recruitingObservational study
Long Term Safety Study in Patients With HLH/MAS in Still's Disease Exposed to Gamifant.
Hemophagocytic Lymphohistiocytosis (HLH), Macrophage Activation Syndrome (MAS)
RecruitingPhase 3
A Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of Plonmarlimab in Subjects With Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis (Also Known as Macrophage Activation Syndrome [MAS])
Relapsed/Refractory Rheumatic and Immunologic Disease-associated Haemophagocytic Lymphohistiocytosis
Active, not recruitingObservational study
Retrospective Study of Immunotherapy Related Toxicities and Factors Impacting Outcomes in Children and Adults With Cancer
Macrophage Activation Syndrome, Primary Hemophagocytic Lymphohistiocytosis
Not yet recruitingObservational study
MASKd: a Study on Kawasaki Disease (KD) Complicated by Macrophage Activation Syndrome (MAS)
Kawasaki Disease, Macrophage Activation Syndrome (MAS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Physician study director
Swedish Orphan Biovitrum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macrophage Activation Syndrome (MAS) and Still Disease, Juvenile Onset, run by Swedish Orphan Biovitrum at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: from 2012 to 2022 (data abdstraction period)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.