Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Joint pain (analogue-numeric scale of pain). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days.
Progression of joint disease (RAPID index 3> 12 = high, between 6.1 and 12 moderate, between 3.1 and 6 low, between 0 and 3 remission). Measurement time: baseline, at 15 and 30, 60, 90, 120 and 180 days.
Key secondary outcomes:
Adverse Events (Present, Absent. Adverse events will be categorized according to the "Common Terminology Criteria for Adverse Events" (CTCAE) version 3.). Measurement: baseline at 30, 60, 90 and 180 days.