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

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ClinicalTrials.gov Identifier: NCT04750863
Recruitment Status : Completed
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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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.

Condition or disease Intervention/treatment
Adult Onset Still Disease 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 Design
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Study Type : Observational
Actual Enrollment : 312 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Adult Onset Still Disease Classification Criteria and Differential Diagnosis at Eighteen Months of Follow-up
Actual Study Start Date : July 15, 2010
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. diagnosis performance of Yamaguchi and Fautrel criteria at 18 months of follow-up [ Time Frame: after 18 months of follow-up ]
    Sensitivity, Specificity, positive predictive value, negative predictive value


Secondary Outcome Measures :
  1. description of differential diagnosis mimicking adult onset still disease [ Time Frame: after 18 months of follow-up ]
  2. identifying factors associated with the occurence of a differential diagnosis during follow-up [ Time Frame: after 18 months of follow-up ]

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04750863    
Other Study ID Numbers: 2021PI001
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
adult onset still disease
differential diagnosis
diagnosis performance
Additional relevant MeSH terms:
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Arthritis, Juvenile
Still's Disease, Adult-Onset
Arthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis, Rheumatoid