Tacrolimus for Thrombocytopenia in SS
Study Details
Study Description
Brief Summary
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2/Phase 3 |
Detailed Description
This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Hydroxychloroquine monotherapy Oral hydroxychloroquine 200mg twice daily for 12 weeks. |
Drug: Hydroxychloroquine
Oral hydroxychloroquine 200mg twice daily for 12weeks.
|
Experimental: Tacrolimus monotherapy Oral tacrolimus 1-2mg twice daily for 12 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.
- ESSDAI improvement [week 12]
Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at week 12.
- ESSPRI improvement [week 12]
Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score 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.
-
Baseline platelet counts within 30-80×109/L.
Exclusion Criteria:
-
Concomitant other systemic autoimmune diseases.
-
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.
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-22PJ1065