Efficacy and Safety of Baricitinib in Sjogren's Syndrome (NCT05016297) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Baricitinib in Sjogren's Syndrome
China87 participantsStarted 2022-07-14
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Must read and understand the informed consent approved by the institutional review board (IRB)/ethics review board (ERB) governing the site and provide written informed consent.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Ability to take oral medication and be willing to adhere to the study intervention regimen.
✓. Male or female, aged between 18-75 years.
✓. Fulfill the 2016 ACR/EULAR classification criteria for primary Sjogren's Syndrome.
✓. With moderate activity (ESSDAI≥5) at the screening visit.
✓. Nonpregnant, nonbreastfeeding female patient
✓. Males with potential for reproduction must agree to practice effective birth control methods described above too.
Exclusion criteria
✕. Have received any of the following medications:
. Biologic treatments for immunologic disease such as etanercept, infliximab, certolizumab, adalimumab, golimumab, tocilizumab, abatacept, ustekinumab, ixekizumab, secukinumab, or anakinra within 4 weeks of screening.
✕. Cyclophosphamide (or any other cytotoxic agent), belimumab, or anifrolumab (or another anti-IFN therapy) within 12 weeks of screening.
✕. Rituximab, any other B cell depleting therapies, or intravenous immunoglobulin (IVIg), or pulse methylprednisolone within 24 weeks of screening.
✕. Have received treatment with glucocorticoids, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus within 4 weeks at the time of screening.
✕. Have received plasmapheresis within 12 weeks of screening.
✕. Have received hemodialysis, peritoneal dialysis, or intestinal dialysis.
✕. History of chronic liver disease or elevated LFTs: