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Because of insufficient enrollement
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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
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Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.
This is a prospective,randomized,open-label,multi-center clinical trial. The aim of this study is to test the efficacy of GC(gluco-corticosteroid)+HCQ(hydroxychloroquine) and GC(glucocorticosteroid)+CTX(cyclophosphamide) with sequential AZA(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in SLE patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1:Hydroxychloroquine | Active Comparator | Hydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months |
|
| Group 2:Cyclophosphamide | Active Comparator | Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month. Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine 200 mg BID for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete remission rate | percentage of patients whose platelet count > 100X109/L | at 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| partial remission rate | percentage of patients whose platelet increase to >30X109/L or with at least a two folds increase of the baseline(ie, pretreatment) count and the absence of bleeding | at 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng, MD | Chinese SLE Treatment And Research Group | Principal Investigator |
| Xiaofeng Zeng, MD | Peking Union Medical College Hospital | Study Chair |
| Xinping Tian, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affiliated Hospital to Bangbu Medical University | Bengbu | Anhui | 233000 | China | ||
| Hebei Provincial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11315344 | Background | Abu-Shakra M, Shoenfeld Y. Azathioprine therapy for patients with systemic lupus erythematosus. Lupus. 2001;10(3):152-3. doi: 10.1191/096120301676669495. | |
| 23698017 | Background | Blasco LM. Hydroxychloroquine alone for severe immune thrombocytopenic purpura associated with systemic lupus erythematosus. Lupus. 2013 Jun;22(7):752-3. doi: 10.1177/0961203313490239. Epub 2013 May 22. No abstract available. |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D003520 | Cyclophosphamide |
| D001379 | Azathioprine |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Cyclophosphamide | Drug | Cyclophosphamide 1000mg intravenous infusion every month for 6 months |
|
|
| Azathioprine | Drug | After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months |
|
|
| Methylprednisolone | Drug | Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months |
|
|
| Shijiazhuang |
| Hebei |
| 050051 |
| China |
| the First Affiliated Hospital of Xiangya Medical University | Changsha | Hunan | 410000 | China |
| the Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010050 | China |
| Sino-Japanese Friendship Hospital of Jilin University | Changchun | Jilin | 410008 | China |
| the Affiliated Hospital of Xian Communication Hospital | Xian | Shanxi | 710000 | China |
| Xijing Hospital | Xian | Shanxi | 710032 | China |
| Xinjiang Provincial Hospital | Ürümqi | Xinjiang | 830001 | China |
| the Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| Beijng Hospital | Beijing | 100006 | China |
| Beijing Chaoyang Hospital | Beijing | 100020 | China |
| China-Japan Friendship Hospital | Beijing | 100029 | China |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| Beijing Xuanwu Hospital | Beijing | 100053 | China |
| General Hospital of Tianjing Medical University | Tianjin | 300052 | China |
| 12944568 | Background | Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254. |
| 15803929 | Result | Contreras G, Tozman E, Nahar N, Metz D. Maintenance therapies for proliferative lupus nephritis: mycophenolate mofetil, azathioprine and intravenous cyclophosphamide. Lupus. 2005;14 Suppl 1:s33-8. doi: 10.1191/0961203305lu2115oa. |
| 21325604 | Result | Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011 Apr 21;117(16):4190-207. doi: 10.1182/blood-2010-08-302984. Epub 2011 Feb 16. |
| 2334081 | Result | Boumpas DT, Barez S, Klippel JH, Balow JE. Intermittent cyclophosphamide for the treatment of autoimmune thrombocytopenia in systemic lupus erythematosus. Ann Intern Med. 1990 May 1;112(9):674-7. doi: 10.7326/0003-4819-112-9-674. |
| 8489547 | Result | Roach BA, Hutchinson GJ. Treatment of refractory, systemic lupus erythematosus-associated thrombocytopenia with intermittent low-dose intravenous cyclophosphamide. Arthritis Rheum. 1993 May;36(5):682-4. doi: 10.1002/art.1780360516. |
| 21503695 | Result | Levine AB, Erkan D. Clinical assessment and management of cytopenias in lupus patients. Curr Rheumatol Rep. 2011 Aug;13(4):291-9. doi: 10.1007/s11926-011-0179-5. |
| 24254965 | Result | Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20. |
| 11824975 | Result | Arnal C, Piette JC, Leone J, Taillan B, Hachulla E, Roudot-Thoraval F, Papo T, Schaeffer A, Bierling P, Godeau B. Treatment of severe immune thrombocytopenia associated with systemic lupus erythematosus: 59 cases. J Rheumatol. 2002 Jan;29(1):75-83. |
| 23462431 | Result | Newman K, Owlia MB, El-Hemaidi I, Akhtari M. Management of immune cytopenias in patients with systemic lupus erythematosus - Old and new. Autoimmun Rev. 2013 May;12(7):784-91. doi: 10.1016/j.autrev.2013.02.001. Epub 2013 Feb 24. |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |