Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
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 |
---|---|---|
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
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.
|
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
Inclusion Criteria:
-
Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
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Baseline platelet counts less than 30×109/L.
Exclusion Criteria:
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Concomitant other systemic autoimmune diseases.
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Other severe complications of Sjogren's syndrome.
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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.
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Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
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Active acute or chronic infections.
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History of malignancy.
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Pregnancy or breastfeeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I-22PJ1065b