CompletedNot Applicable

Assessment of Macrophage Activation syndromE in STill's Disease

United States, Canada, France75 participantsStarted 2023-09-27

Plain-language summary

Assessment of Macrophage activation syndrome in STill's disease: retrospective chart analysis of patient History, Symptom resolution and Treatment characteristics

Who can participate

Age range

6 Months – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>6 months and ≤80 years at the beginning of the index MAS episode. * Diagnosis of Still's disease (sJIA (systemic Juvenile Idiopathic Arthritis) or AOSD (Adult Onset Stills Disease) 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. Exclusion Criteria: * A diagnosis of primary Hemophagocytic Lymphohistiocytosis (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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: 1 year

Time to laboratory value normalization

Timeframe: From Index date up to 26 weeks

Time to Macrophage Activation Syndrome (MAS) laboratory remission

Timeframe: From Index date up to 26 weeks

Time to partial MAS laboratory remission

Timeframe: From Index date up to 26 weeks

Time to tapering of Glucocorticoids (GCs)

Timeframe: from index date to the last of 7 consecutive days

Number of recurrent MAS episodes

Timeframe: through study completion

Administration of organ support care

Timeframe: from the index date until either the end of hospitalization or 26 weeks, whichever occurs later

Trial details

NCT IDNCT06405152

SponsorSwedish Orphan Biovitrum

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-26

View on ClinicalTrials.gov More Macrophage Activation Syndrome trials

Who can participate

Age range

6 Months – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Overall survival

Timeframe: 1 year

Time to laboratory value normalization

Timeframe: From Index date up to 26 weeks

Time to Macrophage Activation Syndrome (MAS) laboratory remission

Timeframe: From Index date up to 26 weeks

Time to partial MAS laboratory remission

Timeframe: From Index date up to 26 weeks

Time to tapering of Glucocorticoids (GCs)

Timeframe: from index date to the last of 7 consecutive days

Number of recurrent MAS episodes

Timeframe: through study completion

Administration of organ support care

Timeframe: from the index date until either the end of hospitalization or 26 weeks, whichever occurs later