Treatment intensification based on disease activity parameters or on cartilage breakdown markers in early rheumatoid arthritis

INTERVENTION:

The study design randomises to two monitoring strategies that lead to subsequent steps in the treatment schedule: either clinical monitoring by DAS28 to achieve and keep the DAS below 2.6 (clinical remission); or: lab monitoring by CTX‐2 to achieve and keep the urinary level of CTX‐2 below 150 ng/µmol creatinine. All patients will receive 'traditional' combination DMARD therapy for a minimum of 22 weeks: step 1 is evaluated at week 8, and step 2 at week 22. Patients will receive treatment intensification according to achieved levels of DAS28 (DAS group) or according to achieved levels of CTX‐2 (CTX group).

CONDITION:

Rheumatoid arthritis ; Musculoskeletal Diseases ; Seropositive rheumatoid arthritis

PRIMARY OUTCOME:

1. DAS28: Disease activity score calculated from swollen and tender joint counts, erythrocyte sedimentation rate (ESR), patient global assessment of disease activity (10 cm Visual Analogue Scale [VAS]); 2. CTX‐2: measured in spot urine (delivered 1 week before visit) together with creatinine (method Garnero, Lyon)

SECONDARY OUTCOME:

1. WHO/ILAR core set; DAS remission, EULAR improvement; ACR remission, ACR20,etc; EuroQoL; 2. Efficacy self assessment: RADAI joint score, fatigue VAS ; 3. Bone Mass: DEXA lumbar spine; Right hip (neck)

INCLUSION CRITERIA:

Patients must have: 1. Rheumatoid arthritis (American College of Rheumatology [ACR] criteria met cumulatively) 2. Requiring treatment: 28‐item Disease Activity Score (DAS28) greater than 3.2 3. Propensity for radiographic progression: urinary CTX‐2 greater than 150 ng/µmol creatinine