Thrombocytopenia
Conditions
Keywords
thrombocytopenia, systemic lupus erythematosus, hydroxychloroquine, cyclophosphamide, remission
Brief summary
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.
Detailed description
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.
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 200 mg BID for 12 months
DRUGCyclophosphamide
Cyclophosphamide 1000mg intravenous infusion every month for 6 months
DRUGAzathioprine
After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
DRUGMethylprednisolone
Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
Sponsors
Peking Union Medical College Hospital
Chinese SLE Treatment And Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE； 2. New onset thrombocytopenia: platelet count \<30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months
Exclusion criteria
1. Thrombocytopenia caused by other reasons, including drugs； 2. Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection 3. Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection; 4. Active HP(Helicopter pylori) infection; 5. Severe liver and kidney dysfunction； 6. Severe neuropsychiatric lupus； 7. No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment； 8. Uncontrolled diabetes or hypertension before entry 9. Active GI bleeding 3 months before entry 10. Intolerant to HCQ in the past treatment history； 11. Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history； 12. Active infection , including bacteria, virus, fungi, mycobacteria 13. Allergy to any of the study medications 14. Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome) 15. Platelet count less than 20X109/L with active bleeding 16. Myelodysplastic diseases 17. Patients with heart and lung function impairment 18. thiopurine S-methyltransferase (TPMT) gene positive -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | at 12 month | percentage of patients whose platelet count \> 100X109/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| partial remission rate | at 12 month | 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 |
Countries
China
Outcome results
None listed