Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

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

Official Title
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Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

Conditions
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Sjogren Syndrome With Other Organ Involvement

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prednisolone monotherapy<br>Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. | Drug: Prednisolone<br>* Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.<br>|
| Experimental: Prednisolone plus Tacrolimus<br>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. | Drug: Prednisolone<br>* Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.<br>Drug: Tacrolimus<br>* Oral Tacrolimus 1-2mg twice daily for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 12. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8. | 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 | 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. | 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. | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's syndrome, Thrombocytopenia, Tacrolimus