Combined Treatment With TNF (Tumor Necrosis Factor) Inhibitor and Pamidronate in AS Patients: Effect on the Radiographic Progression
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- modified stock ankylosing spondylitis spine (mSASS) score
研究概览
简要总结
It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with TNF inhibitor, while randomization will be performed for pamidronate versus placebo group. Primary outcome will be the rate of radiographic progression of AS, calculated after 24 months of combined treatment.
详细描述
It will be a pilot, 2 year, prospective, randomized, double-blind, placebo-controlled (for pamidronate) study. All patients with AS will receive treatment with tumor necrosis factor (TNF) inhibitor, as indicated by local guidelines. Randomization will be performed for pamidronate vs placebo group. Pamidronate will be prescribed as monthly intravenous infusion in the dose of 60 mg/month for the first 6 consecutive months of every study year. Primary outcome will be the rate of radiographic progression of ankylosing spondylitis (AS), calculated after 24 months of combined treatment. Clinical and laboratory disease parameters will serve as secondary outcomes. These outcomes as well as safety assessments will be performed on a monthly basis up to 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •presence of spinal syndesmophytes
- •normal renal and liver function
- •eligibility to receive anti-TNF treatment according to local guidelines
排除标准
- •unwilling to sigh the informed consent
- •presence of significant systemic or organ-limited disorders, other than AS
- •any contraindication for anti-TNF or pamidronate treatment
- •presence of acute dental/periodontal disease
研究组 & 干预措施
pamidronate
pamidronate
干预措施: Pamidronate (Drug)
placebo
placebo
干预措施: Placebo (NaCl 0.9%) (Other)
结局指标
主要结局
modified stock ankylosing spondylitis spine (mSASS) score
时间窗: 24 months
calculated by X-ray films of the spine
Bath ankylosing spondylitis radiographic index (BASRI)
时间窗: 24 months
calculated by X-ray films of the spine
次要结局
- Bath ankylosing spondylitis disease activity index (BASDAI)(monthly from the date of randomization up to 24 months)
- Ankylosing spondylitis disease activity index (ASDAS)(monthly from the date of randomization up to 24 months)
- Bath ankylosing spondylitis functional index (BASFI)(monthly from the date of randomization up to 24 months)
- Bath ankylosing spondylitis metrology index (BASMI)(monthly from the date of randomization up to 24 months)