RA BIODAM Study
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.
Click to access the eCRF for RA BIODAM study.
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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 ongoing, with last patient, last visit expected April 2017. A total of 576 patients were recruited to the study, with 400 completed to date and 146 early withdrawals. Since the study is ongoing and data cleaning is occuring continuously, the data presented below is subject to change.
|Ultrasound sub-study Population||130|
|Mean age (SD)||55.7 (12.9)|
|Mean disease duration at screening in years (SD)||6.4 (7.7)|
|Patients with disease duration < 1 year||137 (24%)|
|Mean prior DMARD exposure (SD)||2.8 (1.7)|
|Treatment started at baseline||
X-Rays of Hands and Feet
|Patients with 12 month X-Rays:||443|
|Patients with 12 and 24 month X-Rays:||329|
|Patients with 12 month US7 Scores:||118|
|Patients with 12 and 24 month US7 Scores:||90|
Biosamples (# of patient visits)
If you are interested in obtaining images and/or biosamples for research purposes, please contact CaRE Arthritis:
Dr. Walter Maksymowych
CaRE Arthritis Ltd.
Unit 210, 316 Windermere Road NW
Edmonton, Alberta, Canada
phone: +1 587 400 9524
Generate a visit schedule for your patient starting from baseline.
Manual DAS-44 calculator using tender and swollen joint counts, ESR, and patient global NRS.
Health Assessment Questionnaire score calculator.