Assessment of Macrophage Activation syndromE in STill's Disease

NCT ID: NCT06405152

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-27

Study Completion Date

2024-09-26

Brief Summary

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

Detailed Description

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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.

Conditions

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Macrophage Activation Syndrome Still's Disease, Adult-Onset Stills Disease, Juvenile-Onset

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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Chart review

Retrospective Chart Review

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uwe Ullman, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum AG Riehenring 182, 4058 Basel, Switzerland

Locations

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Swedish Orphan Biovitrum Research Site

Los Angeles, California, United States

Site Status

Swedish Orphan Biovitrum Research Site

Atlanta, Georgia, United States

Site Status

Swedish Orphan Biovitrum Research Site

Cincinnati, Ohio, United States

Site Status

Swedish Orphan Biovitrum Research Site

Philadelphia, Pennsylvania, United States

Site Status

Swedish Orphan Biovitrum Research Site

Calgary, , Canada

Site Status

Swedish Orphan Biovitrum Research Site

Paris, , France

Site Status

Swedish Orphan Biovitrum Research Site

Heidelberg, , Germany

Site Status

Swedish Orphan Biovitrum Research Site

Milan, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Rome, , Italy

Site Status

Swedish Orphan Biovitrum Research Site

Utrecht, , Netherlands

Site Status

Swedish Orphan Biovitrum Research Site

Barcelona, , Spain

Site Status

Countries

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United States Canada France Germany Italy Netherlands Spain

Other Identifiers

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Sobi.Emapalumab-105

Identifier Type: -

Identifier Source: org_study_id

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