Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up (AOSD-DIF)

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.

Study Overview

• Status: Completed
• Conditions: Adult Onset Still Disease
• Intervention / Treatment: Other: diagnosis criteria performance

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 312

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected adult onset still disease with at least 18 months of follow-up.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
description of differential diagnosis mimicking adult onset still disease	after 18 months of follow-up
identifying factors associated with the occurence of a differential diagnosis during follow-up	after 18 months of follow-up

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2010
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: differential diagnosis; diagnosis performance; adult onset still disease
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile; Still's Disease, Adult-Onset
• Other Study ID Numbers: 2021PI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No