Short summary

Even though Patient-reported outcomes (PROs) have gained increasing attention in monitoring of rheumatoid arthritis (RA) over the past few decades, there is still little evidence about the relationships between PROs and ultrasound and MRI-detected inflammatory and destructive features. To the best our knowledge there are currently no published studies exploring such relationships between patient-reported flares and above mentioned imaging biomarkers. The FLARA cohort represents an unique opportunity of correlating active and structural imaging lesions over 12 months with clinical data collected prospectively by standardized clinical follow-up visits and questionnaires every third month.  

Rationale

Flares, episodes of worsening disease activity are recognized features of rheumatoid arthritis (RA). Although the term "flare" is commonly used, there has been little consensus on how to define and identify flare and different definitions have been used: an inverse of response criteria, the clinician decision to intensify treatment or the patient reported flare (PRF). As fluctuations in disease activity in patients with apparently stable RA are directly related to radiographic progression, PRFs may be one of the factors explaining worsening in joint damage in patients noted to be in remission. There is an unmet need to identify and characterize such episodes of disease worsening because they may be predictive of future worse outcome.  

Objectives:

Comprehensive description of PRF through a multidimensional approach with patient self-reported questionnaires, clinical, laboratory and imaging assessments; exploration of potential predictors of flaring and the agreement between patient- and clinician-reported outcomes at the time of flare. Our aim is to assess whether PRF have an impact on joint damage progression, assessed by conventional X-rays as well as by more sensitive MRI, and whether there is a difference in joint damage progression between patients who report versus do not report flares. Moreover, we aim to evaluate whether patient-reported flares have an impact on the amount of inflammation assessed by ultrasound and MRI and to compare whether patients reporting flares differ from patients who do not report flares in terms of inflammatory findings: synovitis and tenosynovitis on US and synovitis, osteitis and tenosynovitis on MRI. 

Description of the cohort

Patients 18 years or more with RA according to ACR 1987 or ACR/EULAR 2010 criteria, anti-CCP antibody and/or rheumatoid factor positive, DAS28 (CRP) score at baseline 3.2 or less, no swollen joints and stable DMARD treatment without intra-articular steroid injections during 4 weeks prior to study entry 

Data and biological material

self-assessment questionnaires, clinical, laboratory (blood and urine), MRI and ultrasound data.  

Collaborating researchers and departments

Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet- Glostrup, MD, PhD, DMSc

• Professor Mikkel Østergaard

Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet- Glostrup, MD, PhD

• Consultant Lene Terslev