EUCTR2007-000087-25-GB进行中（未招募）不适用
An open label pilot study of Zoledronate (Aclasta 5mg iv) in the treatment of Ankylosing Spondylitis - Zolinas07
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be included in the study the patient must have Ankylosing Spondylitis, be >18y old, have a BASDAI (composite clinical disease activity score) =4.15, be able to have a spinal MR and have one or more lesions on axial MR characteristic of inflammatory lesions of AS.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients <18y, prisoners, complete spinal ankylosis, those unable to give written consent themselves, renal dysfunction (Chronic Kidney Disease grade 4 or 5 by MDRD GFR estimation <30ml/min [e-GFR]), previous anti-TNFalpha therapy in last year, previous reaction to zoledronate, patients with obvious poor dentition/oral health, or those who have recently had root dental work or root/extraction dental work planned within the study period.
- •Also to be excluded: All women of child-bearing potential; pregnant women and those breast-feeding; all those unable to give written consent themselves
研究者
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