Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05694130

Enrollment

110

Registered

2023-01-23

Start date

2023-02-28

Completion date

2024-12-31

Last updated

2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren Syndrome With Other Organ Involvement

Keywords

Sjogren's syndrome, Thrombocytopenia, Tacrolimus

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.

Interventions

DRUGPrednisolone

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

DRUGTacrolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactHua Chen, Dr.

chenhua@pumch.cn861069159962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026