Efficacy and Safety of Baricitinib in Sjogren's Syndrome

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05016297
Phase
PHASE2
Status
Completed

Conditions

  • Sjogren's Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    baricitinib 4mg per day
  • Hydroxychloroquine — DRUG
    Hydroxychloroquine 200mg twice a day

Study Details

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.

Key Dates

Start date
Jul 14, 2022
Status verified
Dec 2024
Primary completion
Aug 22, 2024
Completion
Nov 22, 2024

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: baricitinib 4mg per day
    Regardless of whether they are receiving HCQ, patients in this group will be given baricitinib 4 mg once daily.
  • Active Comparator: HCQ 200mg twice a day
    Patients in this group will be given HCQ 200mg twice a day for 12 weeks. Patients who has no response to HCQ treatment alone at week 12 will be switched to baricitinib + HCQ group and added on baricitinib 4mg per day until the end of the study (week 24).

Primary Outcome Measure

Rate of MCII of ESSDAI [ Time Frame: 12 weeks ]

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