Visit number
|
0/Screening
|
1/baseline
|
2
|
3
|
4
|
5
|
6
|
7
|
Week
|
−4-0
|
0
|
16
|
32
|
48
|
64
|
80
|
96
|
Demographic data
| | | | | | | | |
Age – years
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Female sex – no. (%)
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Disease duration
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Duration of RA symptoms
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Smoking status
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Marital status
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Educational and employment status
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Medical history
|
Former and current arthritis treatment
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Concomitant medication
|
A
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Physical examination
|
40 joint assessment* (TJC/SJC)
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
General physical examination**
|
A
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Height – cm
|
A
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Weight – kg
|
A
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Blood pressure and pulse
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Electrocardiogram
|
A
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Laboratory assessment
|
Routine blood tests***
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Anti-CCP and IgM-RF
|
A
|
-
|
-
|
-
|
A
|
-
|
-
|
A
|
Biomarker collection (blood and urine) for bio-bank
|
-
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Patient reported outcomes
|
Patient: VAS pain, VAS global, VAS fatigue – range 0-100
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Morning stiffness - min
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
HAQ
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
SF-36
|
-
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
EQ-5D
|
-
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Physician’s global assessment of disease activity (VAS) 0-100
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
DAS28 (CRP) score****
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Imaging
|
X-ray hands and feet
|
-
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Controls MRI 2nd to 5th MCP and wrist
|
-
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Dynamic MRI*****
|
-
|
A
|
-
|
-
|
A
|
-
|
-
|
A
|
Intervention MRI2nd to 5th MCP and wrist
|
-
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|
Dynamic MRI*****
|
-
|
A
|
A
|
A
|
A
|
A
|
A
|
A
|