NCT04750863

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2010

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

10.6 years

First QC Date

February 8, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

adult onset still diseasedifferential diagnosisdiagnosis performance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • adults
  • with glycosylated ferritin dosage for suspected adult onset still disease
  • with at least 18 month of follow-up

You may not qualify if:

  • known infectious disease
  • known cancer
  • known active connective tissue disease or vasculitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Still's Disease, Adult-Onset

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 11, 2021

Study Start

July 15, 2010

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share