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Completed

NCT Number: NCT02924623

Discrepancies Between Patients and Physicians in Their Perceptions of Rheumatoid Arthritis Disease Activity

Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).

The objectives of this study were:

1. to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity 2. to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.

* Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline

Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.

Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nîmes

Nîmes, Gard, 30000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fulfilling the ACR-EULAR criteria for RA

Exclusion criteria

  • no RA

Treatment and study plan

Primary outcomes

  1. Patient's global assessment

    Time frame: day 0

    The discordance between the patient's and the evaluator's global assessment will be calculated.

  2. Evaluator's global assessment

    Time frame: day 0

    The discordance between the patient's and the evaluator's global assessment will be calculated.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Discordance Dans l'évaluation d'Activité de la Polyarthrite Rhumatoide

Acronym: DIAPO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2016
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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