Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04750863
Other study ID # 2021PI001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2010
Est. completion date February 1, 2021

Study information

Verified date February 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up of patients. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.


Description:

Adult Onset Still Disease (AOSD) is an acquired inflammatory disease of unknown etiology, presenting with non specific symptoms. Other conditions such as cancer, infection or other inflammatory disease might mimick its symptoms. Its diagnosis rely on sets of criteria, i.e. Fautrel Criteria and Yamaguchi Criteria. However, differential diagnosis might appear during follow-up after an initial diagnosis of AOSD. The aim of this study is to assess diagnostic performance of Fautral and Yamaguchi Criteria after 18 months of follow-up, and to describe differential diagnosis appearing during follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 312
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adults - with glycosylated ferritin dosage for suspected adult onset still disease - with at least 18 month of follow-up Exclusion Criteria: - known infectious disease - known cancer - known active connective tissue disease or vasculitis

Study Design


Intervention

Other:
diagnosis criteria performance


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up Sensitivity, Specificity, positive predictive value, negative predictive value after 18 months of follow-up
Secondary description of differential diagnosis mimicking adult onset still disease after 18 months of follow-up
Secondary identifying factors associated with the occurence of a differential diagnosis during follow-up after 18 months of follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT03651193 - Multi-center Registration Study of Adult Onset Still's Disease in Chinese Population
Completed NCT03311854 - A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH) Phase 2
Recruiting NCT04402086 - Rheumatology Patient Registry and Biorepository