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. 2019 Feb 9;20:68. doi: 10.1186/s12891-019-2453-z

Table 1.

Assessment and evaluation schedule of this study

Assessments Screening tests Drug admin Study period (weeks) Joint puncture *4 CR/PR *5 W/D *6 4 weeks after final drug admin F/U after trial
4 8 12 16 20 24 28 32 36 40 44 48
Informed consent x
Randomization x
Study drug admin/ adherence check x
Physical exam Clinical findings x x *3 x x x x x x x x x x x x x x o
Joint findings x x *3 x x x x x x x x x x x x x x o *7 x o
Joint function x x *3 x x x x x x x x x x x x x x o *7 x o
VAS scale x x *3 x x x x x x x x x x x x x x o *7 x o
Joint fluid findings x
Height x x
Weight x x x x x x x x
Vital signs x x x x x x x x x x x x x x x
Imaging CT or MRI x *1 x x x x x o *7 o *8 o
FDG-PET x *1 x x
X-ray x *1 x x x x x o *7 o *8 o
12-lead ECG x *1 x
Clinical exam Blood test & urinalysis x x x x x x x x
Pregnancy test o *2
F/U evaluation x x o
Adverse event x
Concomitant medications x

x mandatory, o if required, exam examination, VAS visual analog scale, CT computed tomography, MRI magnetic resonance imaging, FGD-PET 18F-fluorodeoxyglucose- positron emission tomography, ECG electrocardiography, F/U follow up, admin administration, CR complete response, PR partial response, W/D withdrawal

*1: Can be used in 28 days before registration, *2: Only for women, *3: Must be evaluated before drug administration, *4: Must be evaluated before joint puncture, *5: Must be evaluated in 8 weeks ± 4 weeks after CR or PR, *6: Must be evaluated in ±7 days of final drug administration and before initiating post-treatments *7: Not necessary if disease progression is detected or post-treatments are initiated before “the timing of drug withdrawal” *8: Not necessary if disease progression is detected or post-treatments are initiated before “28 days after final drug administration” *9: Must be done until detection of progression or post-treatment initiation