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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 July 2021 |
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Main ID: |
NCT04916756 |
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Date of registration:
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01/06/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients
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Scientific title:
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A Prospective Pilot Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients |
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Date of first enrolment:
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January 16, 2020 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04916756 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Xiaomei Leng, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Peking Union Medical College Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. fulfill the criteria of the 2016 American College of Rheumatology (ACR)/European
League Against Rheumatism (EULAR) classification for primary SS
2. with moderate or high activity of SS, which was defined as EULAR primary SS disease
activity index (ESSDAI) =5
3. 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 Criteria:
1. patients diagnosed with an active central nervous system disease or dysfunction of a
major organ (heart, liver, kidney)
2. pregnant or lactating women
3. current severe infections
4. undergoing glucocorticoids or immunosuppressants treatment with stable dosage for less
than 12 weeks
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sjogren's Syndrome
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Intervention(s)
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Drug: Baricitinib 2 MG
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Primary Outcome(s)
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ESSDAI
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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MCII of ESSDAI
[Time Frame: 12 and 24 weeks]
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PGA
[Time Frame: 12 and 24 weeks]
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remissions of organ involvement
[Time Frame: 12 and 24 weeks]
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ESSPRI
[Time Frame: 12 and 24 weeks]
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ESSDAI
[Time Frame: 24 weeks]
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Secondary ID(s)
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PekingUMCH-ZS-2497
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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