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

NCT02924623 | Completed

• 1 other identifier: LOCAL/2015/CGV-03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity
2. 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.
3. 3.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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Patient's global assessment

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

  day 0

• Evaluator's global assessment

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

  day 0

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

from the south of France (Nîmes, Montpellier, Toulouse, Bordeaux, Limoge), fulfilling the ACR-EULAR criteria for RA

You may qualify if:

• fulfilling the ACR-EULAR criteria for RA

You may not qualify if:

• no RA

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nîmes

Nîmes, Gard, 30000, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cécile Gaujoux-Viala, MD, PhD

  CHU Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: October 5, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 25, 2019

Record last verified: 2019-01

Locations

FR (1)