Efficacy & Safety of Baricitinib in Sjogren's Syndrome

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

All participants will be divided into HCQ group or HCQ + baricitinib group randomly. On the basis of the HCQ treatment before, the participants in the latter group will be given baricitinib 4mg once a day. The participants will come to visit at week 0, 4, 8, 12, 16, 20 and 24. The final evaluation will be at week 24. The participants who has no response to HCQ treatment alone at week 12 will be switched to baricitinib + HCQ group and treated with baricitinib 4mg per day until the end of the study (week 24). Baseline information included demographics, SS duration, clinical manifestations, laboratory parameters, current medications, and disease activity. Laboratory tests, including complete blood counts, urinalysis, liver and renal function tests, ESR, and IgG test were performed at each visit. Disease activity was assessed using the ESSDAI, EULAR primary SS patient reported index (ESSPRI), and physician global assessment (PGA) scores. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05016297
Study type	Interventional
Source	Peking Union Medical College Hospital
Contact	Xiaomei Leng, Dr.
Phone	+8613681057089
Email	lengxm@gmail.com
Status	Recruiting
Phase	Phase 2
Start date	July 14, 2022
Completion date	October 15, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms