Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
研究概览
简要总结
To evaluate the effects of denosumab on erosion healing and change in physical function in RA patients.
详细描述
This is a randomized, double-blind, placebo-controlled study, which aimed to evaluate the effects of denosumab on erosion healing and change in physical function in rheumatoid arthritis (RA) patients in low-disease activity or remission receiving synthetic DMARDs (sDMARDs) treatment using High-resolution peripheral quantitative CT (HR-pQCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •DAS28 ≤5.1
- •without severe deformity in MCP joints which would influence the longitudinal assessment of HR-pQCT
排除标准
- •RA functional status class IV (limited in ability to perform usual self-care, vocational, and avocational activities)
- •treatment with any biologic DMARDs for RA treatment within 8 weeks before randomisation
- •pregnancy or premenopausal women planning pregnancy
- •previous use of denosumab, zoledronic acid or teriparatide
- •Hyperparathyroidism
- •contraindications to denosumab
- •Bisphosphonate, biologic DMARDs and the use of oral glucocorticoid >10 mg/day (prednisolone equivalent)
研究组 & 干预措施
Denosumab
Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
干预措施: Denosumab (Drug)
Placebo
Subcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
干预措施: Placebo (Other)
结局指标
主要结局
The percentage of patients with erosion healing determined using HR-pQCT on MCP 2-4
时间窗: 24 months
1). A decrease in erosion volume of ≥ smallest detectable change (SDC) from baseline, and 2). The presence of \> SDC in osteosclerosis at the margin of erosion.
次要结局
- Erosion progression(12 and 24 month)
- Change in various patient-reported outcomes(12 and 24 month)
- Radiographic progression(12 and 24 months)
- Association between the changes in erosion size on HR-pQCT, van der Heijde-Sharp score on radiograph and HAQ(24 month)
- Changes in joint space width (minimal, maximal, asymmetry and distribution) using HR-pQCT(12 and 24 month)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong