Systemic Lupus Erythematosus
Conditions
Interventions
IL-2 group:IL-2
IL-2 + Rapamycin group :IL-2 and Rapamycin
non IL-2 or IL-6 antagonist group :Glucocorticoids and DMARDs
Sponsors
the Second Hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 and 65 years; 2. SLE patients who meet 1997 ACR criteria; 3. Clinical manifestations with one of the following conditions:Thrombocytopenia, disease-associated rash, non-infectious type of fever, mouth ulcers, urinary protein = 0.5g, new onset of vasculitis such as thrombosis and gangrene, NPSLE; 4. The laboratory has at least on of the following conditions: ANA> 1:160, AnuA antibody, dsDNA antibodies, immune globulin, complement C3 and C4 decreased, leukopenia<3×10^9/l, thrombocytopenia<100×10^9/L; The standard treatment is ineffective or relapse; 5. SLEDAI = 5 score; 6. Subject is negative in pregnancy test and agrees to use effective contraception during the study and for at least 6 months after stopping study treatment; 7. Subject is able to comply with scheduled visits, treatment plans and laboratory tests and other study procedures; 8. Subject or subjects legal representative has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients are wholly disabled and have little or no self-care ability, such as being bedridden or confined to a wheelchair; 2. Patients have a diagnosis of any systemic inflammatory disease other than SLE such as RA, which symptoms and signs are expected to affect the evaluation of experimental drugs; 3. Patients have a history of malignancy or are suffering malignant disease within 5 years prior to study entry; 4. Patients have a history of chronic or severe infection within 2 months or a history of oppotunistic infection within 6 months; 5. Patients have active hepatitis or suffer from the infection of hepatitis C virus (HCV); 6. Patients suffer from the infection of human immunodeficiency virus (HIV); 7. Patients have a history of lymphoproliferative disease; Have multiple sclerosis or demyelinating disease of central nervous system; Have experienced or are experiencing congestive heart failure; Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness; 8. Treated by rituximab or other biological agents in post three months; 9. Protein purified derivative (PPD) test is positive, or ( and ) X - ray film showed signs of lung infection or have close contact with patients with tuberculosis (TB); 10. Patients were recruited to other clinical trial(s) involving an investigational medicinal product or are currently receiving or have received biological agents therapy within 4 weeks prior to study entry; 11. Patients are allergic to the drug compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoint (SLEDAI); | — |
Secondary
| Measure | Time frame |
|---|---|
| peripheral blood lymphocyte subsets;CD4+T subgroup; | — |
Countries
China
Contacts
Public ContactXiaofeng Li
The Second Hospital of Shanxi Medical University
Outcome results
None listed