A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 90
- 试验地点
- 19
- 主要终点
- Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
研究概览
简要总结
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female subjects aged 18 years and over at the time of consent to the study.
- •Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
- •Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
- •Active axial involvement defined by mini BASDAI
排除标准
- •Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- •Subjects who have received any previous treatment with etanercept or other TNFα inhibitors or biologic agents.
- •Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
研究组 & 干预措施
etanercept
Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
干预措施: etanercept (Drug)
etanercept-placebo
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
干预措施: etanercept (Drug)
etanercept-placebo
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
时间窗: Week 8
Diary data from the 7 days prior to respective visit were used to evaluate the endpoint, where the score was only calculated if at least 5 of the 7 days data were available. Score was calculated from NSAID usage completed on diary cards considering NSAID type, total daily dose and number of days consumed. The Daily diclofenac-equivalent dose score was derived by converting each daily dose of NSAID to a percentage dose equivalent of 150 mg diclofenac; e.g. 1000 mg naproxen is equivalent to 150 mg diclofenac. For each NSAID, the percentage diclofenac-equivalent score is then multiplied by daily dose frequency and proportion of the period where dose was taken. Ie Score=M x F x n/N (M: Percentage dose equivalent to diclofenac; F=Daily Dose Frequency; n=number of days with NSAID; N=number of days in period). The NSAID ASAS score is the sum of all such scores for all NSAIDs taken during the period. The minimum value is 0 and a higher NSAID-ASAS value indicates greater NSAIDs consumption.
次要结局
- Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.(Week 8)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.(Week 4)
- Change From Baseline in BASDAI at Week 8(Week 8)
- Change From Baseline in BASDAI Score at Weeks 12 and 16.(Week 12 and 16)
- Number of Participants Using NSAIDs at Week 8.(Week 8)
- Number of Participants Achieving ASAS 20 at Week 8(Week 8)
- Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.(Weeks 4, 12 and 16)
- Change From Baseline in Mini BASDAI at Week 8 (AUC).(Week 8)
- Number of Participants Achieved BASDAI 50 at Week 8.(Week 8)
- Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.(Weeks 4, 12 and 16)
- Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16(Weeks 4, 12 and 16)
- Number of Participants Achieving ASAS 70 at Week 8(Week 8)
- Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.(Week 4)
- Change From Baseline in ASDAS CRP Score at Week 8.(Week 8)
- Number of Participants Achieving ASAS 40 at Week 8(Week 8)
- Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.(Weeks 4, 12 and 16)
- Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.(Weeks 12 and 16)
- Change From Baseline in ASDAS ESR Score at Week 8.(Week 8)
- Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)(Week 16)
- Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8(Week 8)
- Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.(Week 4)
- Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.(Weeks 12 and 16)
- Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)(Week 16)