Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05694130

Collaborator

(none)

110

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren Syndrome With Other Organ Involvement	Drug: Prednisolone Drug: Tacrolimus	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Prednisolone monotherapy

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

Drug: Prednisolone

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

Experimental: Prednisolone plus 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.

Drug: Prednisolone

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

Drug: Tacrolimus

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Immunoglobulins [week 12]
Change from baseline in Immunoglobulin (IgG, IgM and IgA) levels at week 12.
Rheumatoid Factor [week 12]
Change from baseline in rheumatoid factor level at week 12.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.