Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Phase 2

Not yet recruiting

• Conditions: Sjogren Syndrome With Other Organ Involvement
• Interventions: Drug: Prednisolone; Drug: Tacrolimus

• Registration Number: NCT05694130
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Last Update Submitted: 2023-01-12
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-23
• Study Start: 2023-02
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone plus Tacrolimus	Tacrolimus	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.
Prednisolone monotherapy	Prednisolone	Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Prednisolone plus Tacrolimus	Prednisolone	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Partial response rate	week 4, week 8 and week 12	Partial response (platelet counts 50-100×10\^9/L) rates at week 4, week 8 and week 12
ESSDAI improvement	week 12	Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12.
ESSPRI improvement	week 12	Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12.
Complete response rate	week 4 and week 8	Complete response (platelet counts \> 100×10\^9/L) rates at week 4 and week 8.