Efficacy and Safety of Baricitinib in Sjogren's Syndrome

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 evaluate the efficacy and safety of baricitinib in active pSS patients. The participants will be randomized (1:2) to receive HCQ (200mg twice a day) or baricitinib (4mg per day) with or without 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.

Timeline

Start

2022-07-14

Primary completion

2024-08-22

Completion

2024-11-22

Publications

• Bai W, Yang F, Xu H, Wei W, Li H, Zhang L, Zhao Y, Shi X, Zhang Y, Zeng X, Leng X. A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren's syndrome patients. Trials. 2023 Feb 15;24(1):112. doi: 10.1186/s13063-023-07087-5.

Drugs

Indications