Back to resultsTacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
Primary Purpose
Sjogren Syndrome With Other Organ Involvement
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prednisolone
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Sjogren Syndrome With Other Organ Involvement focused on measuring Sjogren's syndrome, Thrombocytopenia, Tacrolimus
Eligibility Criteria
Inclusion Criteria: Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria. Baseline platelet counts less than 30×109/L. Exclusion Criteria: Concomitant other systemic autoimmune diseases. Other severe complications of Sjogren's syndrome. Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL. Received glucocorticoids, immunosuppressants, or biological agents within 3 months. Active acute or chronic infections. History of malignancy. Pregnancy or breastfeeding.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Prednisolone monotherapy
Prednisolone plus Tacrolimus
Arm Description
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks.
Outcomes
Primary Outcome Measures
Complete response rate
Complete response (platelet counts > 100×10^9/L) rates at week 12.
Secondary Outcome Measures
Complete response rate
Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8.
Partial response rate
Partial response (platelet counts 50-100×10^9/L) rates at week 4, week 8 and week 12
ESSDAI improvement
Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12.
ESSPRI improvement
Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12.
Full Information
NCT ID
NCT05694130
First Posted
January 12, 2023
Last Updated
January 12, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05694130
Brief Title
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
Official Title
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.
Detailed Description
This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren Syndrome With Other Organ Involvement
Keywords
Sjogren's syndrome, Thrombocytopenia, Tacrolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone monotherapy
Arm Type
Placebo Comparator
Arm Description
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Arm Title
Prednisolone plus Tacrolimus
Arm Type
Experimental
Arm Description
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
Oral Tacrolimus 1-2mg twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Complete response rate
Description
Complete response (platelet counts > 100×10^9/L) rates at week 12.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Complete response rate
Description
Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8.
Time Frame
week 4 and week 8
Title
Partial response rate
Description
Partial response (platelet counts 50-100×10^9/L) rates at week 4, week 8 and week 12
Time Frame
week 4, week 8 and week 12
Title
ESSDAI improvement
Description
Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12.
Time Frame
week 12
Title
ESSPRI improvement
Description
Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12.
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Immunoglobulins
Description
Change from baseline in Immunoglobulin (IgG, IgM and IgA) levels at week 12.
Time Frame
week 12
Title
Rheumatoid Factor
Description
Change from baseline in rheumatoid factor level at week 12.
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
Baseline platelet counts less than 30×109/L.
Exclusion Criteria:
Concomitant other systemic autoimmune diseases.
Other severe complications of Sjogren's syndrome.
Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
Active acute or chronic infections.
History of malignancy.
Pregnancy or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Chen, Dr.
Phone
861069159962
Email
chenhua@pumch.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
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