The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
Patients received the test group Placebo weekly administered subcutaneously for 24 times.
Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Remegen,Ltd.
Yantai, Shandong, China
The amount of change of European League Against Rheumatism Sjögren's syndrome disease activity(ESSDAI) score compared to the baseline at week 24.
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular,peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
Time frame: week 24
The amount of change of ESSDAI score compared to the baseline at week 12.
ESSDAI= European League Against Rheumatism Sjögren's syndrome disease activity index score.The ESSDAI includes It includes 12 domains (ie, organ systems: cutaneous,respiratory, renal, articular, muscular,peripheral nervous system (PNS), central nervous system (CNS), haematological, glandular,constitutional,lymphadenopathic,biological).. Each domain is divided into 3-4 levels of activity.The higher the score, the more serious the symptoms ,that is,the worse the results.Subscales are combined by summed.
Time frame: week 12
The amount of change of European League Against Rheumatism Sjögren'sSyndrome Patient Reported Index(ESSPRI) score compared to the baseline at week 12 and week 24
European League Against Rheumatism Sjögren's Syndrome Patient Reported Index.Dryness, pain, somatic and mental fatigue were identified as the main symptoms of patients with primary SS. It was suspected that a single 0-10 numerical scale for each domain was sufficient to assess these symptoms.The higher values represent a worse outcome.Subscales are combined by averaged.
Time frame: week 12,24
Doctors assess overall changes in disease activity relative to baseline at week 12 and week 24
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.
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Time frame: week 12,24
Overall patient assessment of disease activity compared to baseline at week 12 and week 24
The measurement tool is Visual Analogue Scale/Score(VAS). The participant assesses his/her own disease activity on a VAS of 0 - 100 mm on the questionnaire form.
Time frame: week 12,24
Changes in short form(SF)-36 relative to baseline at week 12 and week 24
SF-36=36-item short form. As a concise health questionnaire, SF-36 summarized the quality of life of the subjects from eight aspects: physiological function, physical pain, general health condition, energy, social function, emotional function and mental health.The SF-361 is a self-report, 36 item survey measuring health-related quality-of-life. Thirty-five items are used to construct 8 scales. An additional item measures health transition.The higher values represent a better outcome.Subscales are combined by averaged.
Time frame: week 12,24
Statistical Analysis of the variation of multidimensional fatigue inventory relative to baseline at week 12 and week 24
Multidimensional Fatigue Inventory.The MFI is a 20-item scale designed to evaluate fi ve dimensions of fatigue: general fatigue, physical fatigue, reduced motivation,reduced activity, and mental fatigue.The higher values represent a worse outcome,Subscales are combined by summed.
Time frame: week 12,24