A Pilot Study of Technetium [99Tc] Methylene Diphosphonate in the Treatment of Psoriatic Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving DAS28-CRP<=3.2
研究概览
简要总结
This study is aim to evaluate the efficacy and safety of technetium [99Tc] methylene diphosphonate (99Tc-MDP, trade name: Yunke) in the treatment of psoriatic arthritis.
详细描述
This is a single-arm, open label, 24 weeks study. Patients with psoriatic arthritis get 99Tc-MDP 22mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years of age;
- •Clinical diagnosis of PsA according to the CASPAR classification criteria
- •Active PsA at baseline defined as ≥ 3 tender joints and ≥ 3 swollen joints
- •If subjects were taking csDMARDs, the doses of csDMARDs had to be stable for at least 4 weeks and had to remain the same during the trial
- •The application of bDMARDs and tsDMARDs should meet the following requirements:
- •Etanercept and its biological analogues: stop at least 4 weeks prior to their baseline visit;
- •Other biological: stop at least 6 months prior to their baseline visit
- •tsDMARDs: stop at least 8 weeks prior to their baseline visit
- •If subjects were taking glucocorticoids, the doses of GC(prednisone < 10mg) had to be stable for at least 4 weeks and had to remain the same during the trial;
- •Non steroidal anti-inflammatory drugs: if applied, the dose was stable one week prior to their baseline visit
- •Negative pregnancy test for child-bearing women at screening and baseline
- •Provide written informed consent
排除标准
- •Patients with severe heart, liver, kidney and other important organ diseases
- •Abnormal liver function (ALT or AST is 2 times higher than normal)
- •White blood cell count less than 4,000/mm^3 (less than 4 X 10^9/L)
- •Platelet count less than 100,000/mm^3 (less than 100 X 10^9/L)
- •Serum creatinine more than or equal to 1.5 mg/dL (less than or equal to 132.6 μmol/L)
- •Pregnancy or breastfeeding women
- •Contraindications to 99Tc-MDP therapy and/or known hypersensitivity to 99Tc-MDP
- •Participated in other drugs clinical trials within 4 weeks
研究组 & 干预措施
99Tc methylene diphosphonate
99Tc-MDP was applied as follows: for each course of treatment, 99Tc-MDP 22 mg (5.5mg/set, four sets) was injected intravenously once a day for 7 successive days, one course every 4 weeks until week 24.
干预措施: 99Tc methylene diphosphonate (Drug)
结局指标
主要结局
Proportion of Patients Achieving DAS28-CRP<=3.2
时间窗: 24 weeks
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of \<=3.2 indicates low disease activity. \<2.6 means disease remission
Proportion of Patients Achieving DAS28-ESR<=3.2
时间窗: 24 weeks
DAS28-ESR: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (ESR) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-ESR score of \<=3.2 indicates low disease activity. \<2.6 means disease remission
次要结局
- Change in PASI From Baseline From Baseline(24 weeks)
- Change in HAQ-DI Score From Baseline(24 weeks)
- ACR20(12 weeks)
- Change in Disease Activity in Psoriatic Arthritis Score (DAPSA) Score From Baseline(24 weeks)
- Percentage of Participants in MDA(24 weeks)
- Change in Tender Joint Count (TJC) 68 from baseline(12 weeks and 24 weeks)
- Change in Swollen Joint Count (SJC) 66 from baseline(12 weeks and 24 weeks)