Assessment of Macrophage Activation syndromE in STill's Disease

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Months - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06405152
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Swedish Orphan Biovitrum
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexei Grom, ProfFabrizio de Benedetti, Prof
Principal Investigator Affiliation	Children's Hospital Medical Center, CincinnatiOspedale Pediatrico Bambino Gesù, Rome
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Germany, Italy, Netherlands, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Macrophage Activation Syndrome, Still's Disease, Adult-Onset, Stills Disease, Juvenile-Onset

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Swedish Orphan Biovitrum Research Site, Los Angeles, California

Status

Recruiting

Address

Swedish Orphan Biovitrum Research Site

Los Angeles, California, 90095

Site Contact

[email protected]

+46 8 6972000

Swedish Orphan Biovitrum Research Site, Atlanta, Georgia

Status

Recruiting