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This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.
This study evaluates the efficacy and safety of Tacrolimus for the treatment of thrombocytopenia in Sjogren's syndrome patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine monotherapy | Placebo Comparator | Oral hydroxychloroquine 200mg twice daily for 12 weeks. |
|
| Tacrolimus monotherapy | Experimental | Oral tacrolimus 1-2mg twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Oral hydroxychloroquine 200mg twice daily for 12weeks. |
|
| 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 |
| ESSDAI improvement | Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 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 |
|---|---|
| D006886 | Hydroxychloroquine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Tacrolimus | Drug | Oral Tacrolimus 1-2mg twice daily for 12 weeks. |
|
| week 12 |
| ESSPRI improvement | Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score 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 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |