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

Rheumatoid Arthritis Clinical Trial

— DIAPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924623
• Other study ID #: LOCAL/2015/CGV-03
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• fulfilling the ACR-EULAR criteria for RA

Exclusion Criteria:

• no RA

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's global assessment	The discordance between the patient's and the evaluator's global assessment will be calculated.	day 0
Primary	Evaluator's global assessment	The discordance between the patient's and the evaluator's global assessment will be calculated.	day 0