EUCTR2013-005001-31-ES进行中（未招募）1 期
Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid
Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)0 个研究点开始时间: 2014年2月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Age ? 18 years
- •2. Patients with RA of less than 2 years of evolution
- •3. DMARD therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within COBRA strategy) on stable dose for at least 6 weeks prior to study entry
- •4. Patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid
- •5. Low disease activity (DAS28 <3.2)
- •6. Im case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid
- •7. Signed informed consent
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Previous or current treatment with biological drugs used for the treatment of RA (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab)
- •2. Pretreatment with:
- •a. Bisphosphonates in the 5 years prior to the onset of RA
- •b. Calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of RA
- •3. Contraindication to treatment with zoledronic acid:
- •a. Hypersensitivity to bisphosphonates
- •b. Hypocalcemia
- •c. Glomerular filtration rate <35 mL / min
- •d. Pregnant (negative pregnancy test) and lactating women
- •e. Poor oral hygiene
- •f. Pending invasive dental procedure
- •4. Serum levels of calcidiol lower than 25 nmol/L (10 ng/mL).
- •5. Simultaneous participation in another clinical trial
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