NCT03425812招募中不适用
Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
研究概览
简要总结
The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;
详细描述
To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;
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
- None
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
- •Capable of giving informed consent and complying with the examination program of the protocol;
- •Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
- •Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS<1.3；
- •Participants must fulfill the criteria of remission of aSpA defined as ASDAS<1.3，then continuous to evaluate every four weeks for three times and ASDAS<1.3 each time.
- •Laboratory results must fulfill following requirements: Hb≥85g/L；3.5×109/L≤WBC Count ≤10×109/L；Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
- •The pregnancy test must be negative for women of childbearing age; Efficient contraception must be taken for both male and female participants during the trial period and within three months after the end of the trial.
排除标准
- •Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
- •Participants who are intolerant of NSAIDs;
- •Participants who are in active axSpA episodes;
- •Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
- •Participants who were in acute infection or acute attack of chronic infection during screening period;
- •At the time of screening, participants who were in the acute stage of acute infection or chronic infection, and if the acute infection had improved, they could be re-screened.
- •Participants who suffer from invasive fungal infections (e.g. histoplasma, coccidiosis's, candida, aspergillus, blastomyces, pneumocystis, etc.) within the first 6 months of screening; Or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria);
- •Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
- •Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
- •Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
- •Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).
研究组 & 干预措施
Non- NSAIDS group
Experimental
To withdraw NSAIDS therapy
干预措施: To withdraw NSAIDs therapy (Drug)
NSAIDS group
Active Comparator
To continue NSAIDS therapy
干预措施: To continue NSAIDs therapy (Drug)
结局指标
主要结局
Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease
时间窗: From Week 0 (baseline) to Week24
ASDAS active disease is defined as ΔASDAS-CRP≥0.9. The ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation.
次要结局
- Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES)(From Week 0 (baseline) to Week24)
- Change in Short Form-36 Physical Component Summary (SF-36 PCS)(From Week 0 (baseline) to Week24)
- Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire(From Week 0 (baseline) to Week24)
- Change in total Back Pain(From Week 0 (baseline) to Week24)
- Change in Number of swelling and tendons affected by enthesitis(From Week 0 (baseline) to Week24)
- Comparison of BASFI and BASMI scores between different groups(Week12 and Week24)
- Change in Patient global assessment of disease activity(From Week 0 (baseline) to Week24)
- Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(From Week 0 (baseline) to Week24)
- Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(From Week 0 (baseline) to Week24)
- Change in Chest Expansion(From Week 0 (baseline) to Week24)
- Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR)(From Week 0 (baseline) to Week24)
- Observation of relapse time after withdrawal of NSAIDs in remission patients(From Week 0 (baseline) to Week24)
- The difference of flare rate between in patients with different sacroiliac joint grades on X-ray among different groups.(Week12 and Week24)
- Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)(From Week 0 (baseline) to Week24)
- The difference of flare rate between different treatment groups(Week12 and Week24)
- The difference of osteophyte formation between different groups on Modified Stoke ankylosing spondylitis spine score (mSASSS).(Week0 and Week24)
- The difference of flare rate in patients with different MRI scores of sacroiliac joint.(Week0 and Week24)
- Differences in MRI scores among different groups by SPARCC SSS method.(weeks-16, week 0, week 12 and week 24)
研究者
研究点 (1)
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