RA BIODAM is an international study (10 countries) aimed at the validation of biomarkers as predictors of joint damage and development of a personalized treatment strategy for patients with rheumatoid arthritis. Patients recruited to the study must have active disease (DAS44 > 2.4) and must have a major treatment change instituted at baseline. A major treatment change is:

  • Start DMARD or biologic therapy
  • Change in DMARD or biologic therapy

Visits occur every 3 months, at which time the DAS44 is calculated, and if greater than 2.4, another major treatment change is instituted as above. Switching from an anti-TNFα agent to another biologic is allowed after baseline.

Serum and urine samples are collected at every visit, and X-Rays of hands and feet are taken every 6 months. RNA samples were collected for a subset of patients on anti-TNFα therapy. A subset of the patient population was also enrolled in an ultrasound sub-study, with ultrasound assessments done at every visit using the US7 Scoring methodology.

The study is concluded. A total of 571 evaluable patients were recruited to the study, with 440 completed through 24 months and 131 early withdrawals.

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Patient Population

Population: 571
Ultrasound sub-study population: 128
Mean age (SD): 55.7 (12.9)
Mean disease duration at screening in years (SD): 6.5 (8.0)
Patients with disease duration <1 year: 134 (23.5%)
Mean prior DMARD exposure (SD): 1.2 (1.1)
Treatment started at baseline:
1st DMARD: 142
1st anti-TNFα: 234
Change DMARD: 195

X-Rays of Hands and Feet

All radiographs submitted for the study have been scored with the Sharp / van der Heijde scoring method.

Patients with scored Baseline and 12-month X-Rays: 449
Patients with scored Baseline and 24-month X-Rays: 413


Approximately 20ml of Serum and 20ml of Urine were collected at each patient visit. Samples were stored locally at -80C and shipped to CaRE Arthritis in containers charged with liquid nitrogen to maintain the temperature. Samples are thawed once to be divided into 0.5ml aliquots, which are re-frozen at -80C.

Serum samples: 4744 patient visits
Urine samples: 4672 patient visits
PAXGene RNA samples: 1052 patient visits