systemic lupus erythematosus
Conditions
Interventions
steroid tapering group:0~6th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d). 6th~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d). 18th~30th month: Pati
steroid maintaining group:0~18th month: mycophenolate mofetil (1g/d) + tacrolimus (2.0mg/d) + steroid (1 pill/d). 18th~30th month: Patients who did not relapse were randomized to therapy with mycophen
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age between 18-65 years old. 2) Systemic lupus erythematosus participants diagnosed with 2019 ACR/EULAR classification criteria, fulfilled with ACR lupus nephritis definition, and have reached treatment target (accord with lupus nephritis clinical remission and DORIS) for at least 6 months. The target is defined as: ?24h urine protein =0.5g/d;?stable of improved renal function (baseline creatinine ±10% or decrease 15%);?cSLEDAI=0 (all scores are required zero, except hypocomplementemia and anti-dsDNA antibody positivity);?PGA score (Physician Global Assessment)<0.5; ?prednisone or equivalent steroid dose=5mg/d;?stable use of immunosuppressants and antimalarial drugs; ?no use of biological agents. 3) According to the physician, the participant can accept this treatment. 4) The participant is willing to join this clinical trial, has good compliance, and could understand and sign the informed consent before the study begins.
Exclusion criteria
Exclusion criteria: 1) SLE complicated with important organ dysfunction, including consciousness disorder, cognitive disorder, renal dysfunction, heart dysfunction (NYHA class 3, 4), pulmonary arterial hypertension, and interstitial lung disease. 2) SLE with active vital organ disease (not satisfied with DORIS), including but not limited to active neuropsychiatric systemic lupus erythematosus, lupus nephritis, thrombocytopenia, hemolytic anemia, myocardial involvement, gastrointestinal involvement, etc. 3) Participants who are allergic to or intolerant with mycophenolate mofetil or tacrolimus. 4) Participants with acute and chronic infections requiring anti-infective treatment, including but not limited to tuberculosis infection, HBV and HCV infection, HIV infection, and CMV infection. 5) Participants who are pregnant or planning to become pregnant. 6) Participants who have used biological agents within 6 months before enrollment. 7) The researcher considers any condition that may cause the participant to be unable to complete the study or bring an obvious risk to the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 1-year flare rate of lupus nephritis participants who reach the treatment target and accept MMF+TAC remedy tapering steroid in the maintenance period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lupus flare (as assessed by SLEDAI and PGA) in SLE participants during the maintenance period after steroid tapering;The changes of serum activity markers (anti-dsDNA antibody and C3 level) in SLE participants after steroid tapering;Proportion of SLE participants with irreversible organ damage (assessed by SLICC/SDI) after steroid tapering;Changes in carotid intima-media thickness after steroid tapering;Biological markers of lupus flare;Differences in health economics between steroid tapering and steroid maintenance participants;The 1-year flare rate of those participants who accept MMF or TAC monotherapy; | — |
Countries
China
Contacts
Public ContactMengtao Li
Peking Union Medical College Hospital
Outcome results
None listed