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NCT06405152 | RECRUITING | Macrophage Activation Syndrome


Assessment of Macrophage Activation syndromE in STill's Disease
Sponsor:

Swedish Orphan Biovitrum

Brief Summary:

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

Condition or disease

Macrophage Activation Syndrome

Still's Disease, Adult-Onset

Stills Disease, Juvenile-Onset

Intervention/treatment

Chart review

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 80 participants
Official Title : Assessment of Macrophage Activation syndromE in STill's Disease: Retrospective Chart Analysis of Patient HistorY, Symptom Resolution and Treatment Characteristics
Actual Study Start Date : 2023-09-27
Estimated Primary Completion Date : 2024-09-19
Estimated Study Completion Date : 2024-09-19

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Months to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Assessment of Macrophage Activation syndromE in STill's Disease

Location Details

NCT06405152


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Locations


RECRUITING

United States, California

Swedish Orphan Biovitrum Research Site

Los Angeles, California, United States, 90095

RECRUITING

United States, Georgia

Swedish Orphan Biovitrum Research Site

Atlanta, Georgia, United States, 30329

RECRUITING

United States, Ohio

Swedish Orphan Biovitrum Research Site

Cincinnati, Ohio, United States, 45229

RECRUITING

United States, Pennsylvania

Swedish Orphan Biovitrum Research Site

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

Canada,

Swedish Orphan Biovitrum Research Site

Calgary, Canada,

RECRUITING

France,

Swedish Orphan Biovitrum Research Site

Paris, France,

RECRUITING

Germany,

Swedish Orphan Biovitrum Research Site

Heidelberg, Germany,

NOT YET RECRUITING

Italy,

Swedish Orphan Biovitrum Research Site

Milan, Italy,

NOT YET RECRUITING

Italy,

Swedish Orphan Biovitrum Research Site

Rome, Italy,

RECRUITING

Netherlands,

Swedish Orphan Biovitrum Research Site

Utrecht, Netherlands,

RECRUITING

Spain,

Swedish Orphan Biovitrum Research Site

Barcelona, Spain,

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