This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
Temporary discontinuation of methotrexate for 1 or 2 weeks
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Proportion of satisfactory vaccine response
as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination
Time frame: 4 weeks
Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains
Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains at 4 weeks and 16 weeks after vaccination
Time frame: 4 weeks and 16 weeks
Proportion of seroprotection for each strain
Time frame: 4 weeks and 16 weeks
Change from baseline in titer (in GMT)
Time frame: 4 weeks and 16 weeks
Change from baseline in DAS28-4 (CRP)
Time frame: 4 weeks and 16 weeks
Disease flare
Time frame: 4 weeks and 16 weeks
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