Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Peking Union Medical College Hospital110 enrolled

Overview

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.

This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Sjogren Syndrome With Other Organ Involvement

Interventions

PrednisoloneDRUG

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

TacrolimusDRUG

Oral Tacrolimus 1-2mg twice daily for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Complete response rate

Complete response (platelet counts \> 100×10\^9/L) rates at week 12.

Time frame: week 12

Secondary Outcomes

Complete response rate

Complete response (platelet counts \> 100×10\^9/L) rates at week 4 and week 8.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: week 12

Central Contacts

Hua Chen, Dr.

CONTACT

861069159962 chenhua@pumch.cn

Data from ClinicalTrials.gov

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