Systemic Lupus Erythematosus
Conditions
Interventions
Experimental group:Add Pitavastatin calcium dispersible tablets to original treatment
Control Group:Add placebo to original treatment
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18-65 years old (including 18 and 65 years old); 2. Meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE diagnostic classification criteria, exclude infections, tumors and other connective tissue diseases and diagnose SLE patients; 3. During the screening period, the Systemic lupus erythematosus disease activity index-2000 (SLEDAI-2K) score =6 points; and at least 1 definite autoantibody test result was positive, including ANA (titer = 1:80) and/or anti-dsDNA antibody and/or anti-Smith antibody. 4. Has received one or more of the following systemic standard treatments allowed by the study protocol: (1). Oral glucocorticoid (prednisone no more than 0.5 mg/kg/d or equivalent drug) treatment for >= 8 weeks before the start of pitavastatin calcium dispersible tablet therapy in the study, and received stable doses of treatment for >= 4 weeks; (2). Received hydroxychloroquine therapy (200-400mg/d) for = 8 weeks before the start of pitavastatin calcium dispersible tablet therapy in the study and received stable doses of therapy for >= 6 weeks; (3) If one or more of the following immunomodulators are used, they must have been treated for >= 12 weeks before the start of pitavastatin calcium dispersible tablet therapy in the study and received a stable dose for .= 6 weeks: mycophenolate mofetil oral (MMF) = of the aforementioned immunomodulatory drugs, the appropriateness of the subject's participation in the research shoule be discussed; 5. Prior to the study, those who willingly provide the written informed consent form voluntarily participated in this project should understand the detailed information regarding the nature, significance, potential benefits, inconveniences, and potential risks of this project, and were able to complete the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. There is severe active lupus nephritis: (proteinuria>6.0g/24h), or have red blood cell tube type of active urinary sediment, or histological evidence of diffuse proliferative glomerulonephritis within 12 weeks prior to screening (if any); 2. The presence of any unstable or active CNS lupus (eg, seizures, acute confusional states, myelitis, stroke or stroke syndrome, SLE-related cerebellar ataxia or dementia, CNS vasculitis, etc.) ; 3. There are other inflammatory diseases that may interfere with the evaluation of efficacy, including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis, dermatomyositis, multiple sclerosis, Crohn's disease or active Lyme sick; 4. Patients with serious heart, brain, lung, liver, kidney, blood, blood vessel, muscle and other important organ system diseases, and the researchers believe that they are not suitable to participate in this study; 5. Known active or recurrent serious infection such as active tuberculosis; chronic infections of hepatitis B (HBV) or hepatitis C (HCV); a history of human immunodeficiency virus (HIV) infection; 6. Suffering from malignant tumor or a history of malignant tumor within 5 years before screening; 7. History of important organ transplantation or hematopoietic stem cell/bone marrow transplantation; 8. Subjects with clinical laboratory examinations at screening showing any of the following abnormalities: patients with LDL-C >4.1 mmol/L; patients with triglyceride >5.7 mmol/L; patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >=2 times the upper limit of normal (ULN) or creatine kinase (CK) >=2 times ULN; Note: In case of abnormal laboratory results during the screening period, a repeat test may be conducted within a 4-week screening period to confirm the abnormal findings. If the results return to normal within the 4-week screening period, the subject may proceed with the study; 9. Received statin therapy within 5 drug half-lives or within 1 months (whichever is longer) before the start of the study; 10. Patients who have received or plan to receive oral medications that may interact with statins during the screening period, within 1 month prior to dosing, or within 5 half-lives of the medication (whichever is longer). These medications include cyclosporine, azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as erythromycin, clarithromycin, telithromycin), fibrates (such as gefefibrate, bezafibrate), HIV protease inhibitors (such as lopinavir, darunavir, ritonavir), tacrolimus, everolimus, sirolimus, niacin, nefazodone, cyclosporine, amiodarone, diltiazem, fusidic acid, or colchicine; 11. Received cyclophosphamide or biologic therapies such as belimumab, rituximab, telitacicept, tocilizumab, alefacept, efalizumab, natalizumab, abatacept, anakinra, brodalumab, secukinumab, ixekizumab, or inhibitors targeting tumor necrosis factor-alpha (TNF-a), IL-1, IL-6, IL-17, or the IFN pathway within 5 drug half-lives or within 3 months (whichever is longer) before the start of the study; 12. Patients with a known history of allergy to any of the components of the investigational product; 13. Congenital immunodeficiency or congenital immunosuppression; 14. Patients with drug addiction, alcohol abuse or mental disorders, unable to cooperate or adhere to treatment, and poor predictability of compliance; 15. Pregnant or lactating women, or subjects (both male and female) with plans for conception w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE Responder Index (SRI-4); | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreased glucocorticoid dose;Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K);BICLA(British Isles Lupus Assessment Group–based Composite Lupus Assessment) response;Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI);Changes in proportions of immune cell subsets;Changes in levels of serum effector cytokines;Changes in immunological parameters;Laboratory testing;Clinical symptoms and organ involvement;Safety assessment Adverse events;Physician's Global Assessment (PGA);modified SELENA-SLEDAI Flare Index (SFI); | — |
Countries
China
Contacts
Public ContactQianjin Lu
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed