Rheumatoid Arthritis Clinical Trial
Official title:
Efficacy and Safety of Eldecalcitol in Preventing Glucocorticoid-induced Bone Loss in Rheumatoid Arthritis Patients (ELEGANT)
The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients.
After having signed informed consent (Day 0), the patients will be screened for enrollment. About 314 eligible patients will be enrolled in this study. The background information of eligible patients including demographic characteristics, history of present illness, medical history, treatment history, etc., related questionnaire, baseline bone mineral density (BMD), X-ray examination result, High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) examination result, quantitative ultrasound (QUS) examination result and lab test result will be collected at Day 0. After enrollment, the following information will be collected at 6 months and/or 12 months: related questionnaire, BMD, X-ray examination result, HR-pQCT examination result, QUS examination result and lab test result, medication adherence and AE information. ;
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