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.
|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:||
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|