Status:
COMPLETED
A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Sjogren's syndrome (pSS) is a systemic autoimmune disease characterized by dysfunction of the exocrine glands, which results in sicca symptoms in affected patients. JAK/STAT signaling pathway ...
Detailed Description
Baseline information included demographics, SS duration, clinical manifestations, laboratory parameters, current medications, and disease activity. Laboratory tests, including complete blood counts, u...
Eligibility Criteria
Inclusion
- fulfill the criteria of the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification for primary SS
- with moderate or high activity of SS, which was defined as EULAR primary SS disease activity index (ESSDAI) ≥5
- with serological activity defined as elevated C-reactive protein, erythrocyte sedimentation rate (ESR), and/or immunoglobulin G (IgG) level (excluding acute and chronic infection and other factors)
Exclusion
- patients diagnosed with an active central nervous system disease or dysfunction of a major organ (heart, liver, kidney)
- pregnant or lactating women
- current severe infections
- undergoing glucocorticoids or immunosuppressants treatment with stable dosage for less than 12 weeks
Key Trial Info
Start Date :
January 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04916756
Start Date
January 16 2020
End Date
March 25 2021
Last Update
June 30 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730