The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
335
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )
Remegen,ltd.
Yantai, Shandong, China
SLE Responder Index (SRI) Response Rate
At Week 52 the percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score and increasing no more than 0.3 points in PGA and no new BILAG A organ domain score or 1 new BILAG B organ domain scores compared with baseline at the time of assessment
Time frame: Week 52
Percent of subjects with ≥ 4 point reduction from baseline in SELENA-SLEDAI score
Time frame: Week 52
Mean Change From Baseline in Physician's global assessment(PGA)
Physician's global assessment, PGA.The measurement tool is Visual Analogue Scale/Score(VAS).The doctor assesses participant's disease activity on a VAS of 0-100 mm on the questionnaire form.The higher values represent a worse outcome.There are not combined subscales.
Time frame: Week 52
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline or ≤ 7.5 mg/Day,During Weeks 44 Through 52.
Time frame: Week 44 through 52
Mean Change From Baseline in Serological Examination Index
Time frame: week 52
The flare time after randomization
Time frame: 52 weeks
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