Efficacy and Safety of Baricitinib in Sjogren's Syndrome
Status:
Not yet recruiting
Trial end date:
2023-09-15
Target enrollment:
Participant gender:
Summary
The investigators had observed that baricitinib was effective and safe in active pSS patients
in a pilot study. So the investigators plan to conduct a multi-center, prospective,
open-label, randomized study to compare the efficacy of baricitinib + hydroxychloroquine
(HCQ) with HCQ alone in active pSS patients. The participants will be randomized (1:2) to
receive HCQ (200mg twice a day) or baricitinib (4mg per day) + HCQ (200mg twice a day) until
week 24. The primary endpoint is the ESSDAI and ESSPRI response (define as an improvement of
ESSDAI at least three points, and ESSPRI at least one point or 15%) at 12 weeks. According to
an expected response rate of 70% in baricitinib + HCQ group and 30% in HCQ group, the
investigators will involve approximately 87 participants (29:58) with 20% drop out rate. The
investigators will switch HCQ to baricitinib + HCQ if the participants has no response at 12
weeks. The investigators hypothesized that baricitinib was effective and safe in active pSS
patients.