Optimal MTX Dose With Folic Acid Randomized Case-control Trial
Status:
Unknown status
Trial end date:
2020-07-30
Target enrollment:
Participant gender:
Summary
This is an open, single-center, randomized,case controlled, prospective study. Previous
studies in China lacked data of efficacy and safety of optimal methotrexate (MTX) dose
with/without other anti-rheumatoid drugs (DMARDs) in the treatment of rheumatoid arthritis
(RA) .Meanwhile there was no study on the optimal folic acid dose in aspect of preventing
side effects of MTX. So we designed the experiment below.
The research planned to recruit 160 RA patients in Meizhou, Guangdong Province,China. The
volunteers had no relief with 10 mg of MTX per week with/without other DMARDs for at least 3
month. They were randomly divided into 1:1 groups. The experimental group would be treated
with original dMARDs ,incremental MTX( gradually increased to the optimal dose (0.3 mg/kg) in
the first 12 weeks）and folic acid (the dose adjusted as appropriate with range from 5 mg to
90 mg per week) . While the control group would be treated with original MTX（10mg per week)
and incremental original dMARDs( gradually increased to the maximum dose in the first 12
weeks). The two groups would keep the 12th week treatment last to the 36th week, and the
efficacy and safety indexes would be evaluated during the whole study.
The objective of the study was to determine the efficacy and safety of the optimal dose of
MTX in Chinese patients with rheumatoid arthritis, and to determine the efficacy and optimal
prevention dose of folic acid in Chinese RA patients. It might be helpful for Chinese
rheumatologists to use MTX accurately and efficiently to treat RA patients in clinical work.