JPRN-jRCTs071180018已完成4 期
Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
The aim of this exploratory study was to compare the effects of denosumab in combination with csDMARDs and csDMARDs alone on ER inhibition by HRpQCT in patients receiving csDMARDs for the treatment of RA. The results of the study suggested that the additional administration of denosumab may be effective in inhibiting the progression of bone erosion and improving bone erosion. Adverse drug reactions of Denosumab treatment were observed in 26.1%, and hypocalcemia was the most common in 17.4%, it was feasible.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who can be visited hospital diagnosed as rheumatoid arthritis by Rheumatoid arthritis classification criteria of ACR (revised in 1987) or ACR / EULAR (2010)
- •2) Patients with low or moderate disease activity
- •3) Patients under treatment with csDMARDs.
- •4) Patients with progressive bone erosion in image examination (either X-ray, MRI or ultrasound)
- •5) Patients who are 20 years older at the time of obtaining informed consent and can consent to the document to participate by my own will
- •6) Male and Female
- •7) Outpatient only
排除标准
- •1) Patients complicated of osteoporosis who have not been treated for osteoporosis
- •2) Patients under treatment with intravenous bisphosphonate formulation and parathyroid hormone formulation
- •3) Patients under treatment with Denosumab
- •4) Patients under treatment with Biological disease-modifying anti-rheumatic drug and JAK inhibitor
- •5) Patients taking adrenal cortex hormone drug in excess of 10 mg / day in terms of prednisolone
- •6) Patients with a history of hypersensitivity to the components of Desnomab
- •7) Patients with hypocalcemia
- •8) Patients who are or may be pregnant
- •9) Patients currently participating in trials or studies of other medicines or medical devices
- •10) Patients who are breastfeeding or who want pregnancy during the study period
- •11) Patients who jugged unsuitable for this study by the investigator
研究者
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