systemic lupus erythematosus
Conditions
Interventions
intervention group:lenalidomide 10mg qd
control group:placebo 10mg qd
Sponsors
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 years. (2) Subjects have been diagnosed as SLE according to 1997 ARA classification criteria or 2012 SLICC classification criteria. Skin involvement have been confirmed as Resvised skin lupus erythematosus disease area and severity index (RCLASI) >= 4. Other manifestations have been stable >= 3 months. (3) Subjects have failed the traditional treatment regimen of 3-month hydroxychloroquine (200-400 mg / day) . (4) The dose of corticosteroids have been below 30mg/d.Pred for at least 1 month. Treatmenet of HCQ and immunosuppressant (excluding cyclophosphamide) remained stable for at least 3 months. (5) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) High disease activity with vital organ involvement: severe thrombocytopenia (PLT 80cell/ul or proteinuria with 24-hour urine protein > 0.5g, newly onset or progressively deteriorate in the nearest 2 weeks), neuropsychiatric lupus, cardiopulmonary involvement (alveolar hemorrhage, pulmonary hypertension, myocardial), gastrointestinal involvement (pseudo-intestinal obstruction). (2) Severe comorbidities: heart failure (NYHA III~IV ), respiratory failure, renal insufficiency (creatinine clearance = 2 times the upper limit of the normal range), myelosuppression (WBC<3.0*10^9/L or Neut<1.5*10^9/L), peripheral neuropathy. (3) Acute severe infections: sepsis and cellulitis, hepatitis B or C virus infection during viral replication, M. tuberculosis infection, and human immunodeficiency virus (HIV). (4) Hypercoagulable state or thrombophilia: hereditary or acquired thrombophilia, history of malignant tumors; history of arterial/venous thrombosis. (5) History of the following drug treatments within 1 month prior to enrollment: high-dose corticosteroids (=1.0 mg/kg/d.pred), or biological agents, or cyclophosphamide, or intravenous immunoglobulin G (IVIG). (6) Patients who are pregnant, could be pregnant, or plan to get pregnant (rule out by urine HCG test paper and medical history). (7) Patients who are allergic to thalidomide or have experienced severe adverse reactions with thalidomide, such as peripheral neuropathy and deep vein thrombosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCLASI;SLEDAI; | — |
Secondary
| Measure | Time frame |
|---|---|
| DLQI;PGA; | — |
Countries
China
Contacts
Public ContactMengtao Li
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Outcome results
None listed