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 |