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Tacrolimus 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
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 12, 2023
    Last Updated
    January 12, 2023
    Sponsor
    Peking Union Medical College Hospital
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    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

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    Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

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