A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren’s syndrome patients

Table 2 The participant timeline

	− 4 weeks (screening)	0 weeks (start medication)	4 weeks	8 weeks	12 weeks (switch checkpoint)	16 weeks	20 weeks	24 weeks (the end of study)
Visit	0	1	2	3	4	5	6	7
informed consent	√
Medical history record	√
Vital signs	√	√	√	√	√	√	√	√
Infection screening like hepatitis and TB	√							√
complete blood cell count	√	√	√	√	√	√	√	√
Renal and liver function test	√	√	√	√	√	√	√	√
Urine routine test	√	√	√	√	√	√	√	√
Acute phase reactants (ESR, CRP)	√	√			√			√
Autoantibodies (antinuclear antibody, anti-SSA, anti-SSB, et al.)	√							√
Immunological parameters (Ig, complement, RF)	√				√			√
Exocrine gland function	√				√			√
Labial salivary gland biopsy	√							√
PGA score	√	√			√			√
ESSDAI score	√	√			√			√
ESSPRI score	√	√			√			√
Adverse events	√	√	√	√	√	√	√	√
Concomitant medication	√	√	√	√	√	√	√	√

ISSN: 1745-6215