Study of the impact of the inclusion of global pain and functional capacity assessment in the definition of remission and its maintenance for rheumatoid arthritis. Aims and methodology.

Background And Objective: The SUMAR project established a definition for remission that includes the patient's perspective (global assessment of pain and HAQ) in the definition of remission in rheumatoid arthritis (RA). This new definition needs to be assessed on clinical practice. The main objective of the RA-Remission study is to estimate the proportion of patients in sustained remission according to SUMAR definition through 2-year follow-up, among patients in SUMAR remission at baseline. This manuscript describes the objectives and methodology of the study.

Materials And Methods: This is a longitudinal, prospective, observational and multicentre study, involving 10 centres. Patients with RA who have achieved clinical remission in accordance to their attending rheumatologist clinical judgement within the last 6 months will be included. Follow-up visits will take place at 3, 6, 12, 12, 18 and 24 months. Ultrasound assessment of the power Doppler (PD) signal for 30 joints and 6 tendon regions will be performed at each participating centre by an expert blinded to all other study findings. Definitions of remission according to SUMAR, PD and activity indices will be used. Sustained remission will be considered for each of the definitions when the patient in remission at the baseline visit maintains it during all follow-up visits. To estimate the proportion of patients maintaining remission at two years with an accuracy of at least 6%, 180 patients will need to be recruited.

Discussion And Conclusions: The main strength of the design is the use of ultrasound assessment as the gold standard for assessing inflammatory activity.