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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.
This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone monotherapy | Placebo Comparator | Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. |
|
| Prednisolone plus Tacrolimus | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 12. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8. | week 4 and week 8 |
| Partial response rate | Partial response (platelet counts 50-100×10^9/L) rates at week 4, week 8 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulins | Change from baseline in Immunoglobulin (IgG, IgM and IgA) levels at week 12. | week 12 |
| Rheumatoid Factor | Change from baseline in rheumatoid factor level at week 12. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Chen, Dr. | Contact | 861069159962 | chenhua@pumch.cn |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Tacrolimus | Drug | Oral Tacrolimus 1-2mg twice daily for 12 weeks. |
|
| week 4, week 8 and week 12 |
| ESSDAI improvement | Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12. | week 12 |
| ESSPRI improvement | Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12. | week 12 |
| week 12 |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |