STRIKE - Treating Patients With Early Axial Spondyloarthritis to Target - a 1 Year Randomized Controlled Study Taking an Intense Treatment Approach Versus Routine Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 主要终点
- Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32
研究概览
简要总结
A study comparing a treat-to-target (T2T) intense treatment approach with routine treatment (Standard of Care [SOC]) in reducing disease activity in participants with axial spondyloarthritis (axSpA).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent before start of study-related assessments or procedures
- •Diagnosis of axSpA (either ankylosing spondylitis or non-radiographic axSpA) and fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA
- •Participants aged ≥ 18 years
- •Disease duration < 5 years
- •Participants must have a Baseline disease activity as defined by an ASDAS ≥ 2.1 or a Bath AS Disease Activity Index (BASDAI) ≥ 4
- •NSAID-naive or not treated with the maximal recommended NSAID dose during the last 2 weeks prior to the Baseline visit
- •Participants must never have failed a NSAID taken at maximal recommended dose for 2 weeks or more.
排除标准
- •Contraindications for NSAIDs or tumor necrosis factor (TNF) blocker according to local labeling
- •If entering the study on concomitant NSAIDs, participants taking the maximal recommended dose during the last 2 weeks prior to the Baseline Visit or have failed or developed intolerance to a NSAID taken at maximal recommended dose for 2 weeks or more at any time
- •Prior exposure to any anti-TNF therapy; any biologic therapy with a potential therapeutic impact on SpA, or participant has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
研究组 & 干预措施
Treat-to-Target (T2T)
Participants initially received treatment with any non-steroidal anti-inflammatory drug (NSAID) at full anti-inflammatory dose for 4 weeks. After 4 weeks, if the Ankylosing Spondylitis Disease Activity Score (ASDAS) was ≥ 2.1 or treatment with NSAID 1 was not tolerated, treatment was changed to a second NSAID at full anti-inflammatory dose for 4 weeks. If ASDAS was ≥ 2.1 after 4 weeks of NSAID 2 or treatment with the chosen NSAID was not tolerated, , participants were switched to receive a combination of NSAID and adalimumab 40 mg every other week for up to 48 weeks.
干预措施: Adalimumab (Biological)
Standard of Care (SOC)
Participants received treatment as prescribed by their physician according to the local standard of care.
干预措施: Non-steroidal Anti-inflammatory Drugs (NSAIDs) (Other)
结局指标
主要结局
Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32
时间窗: Week 32
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 (C-reactive protein \[CRP\] or erythrocyte sedimentation rate \[ESR\]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: \< 1.3 for "inactive disease"; ≥ 1.3 to \< 2.1 for "moderate disease activity"; ≥ 2.1 to ≤ 3.5 for "high disease activity" and \> 3.5 for "very high disease activity." The percentage of participants with ASDAS inactive disease (defined as ASDAS \< 1.3) calculated using CRP is reported.
次要结局
- Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment(Baseline, week 32, and week 52)
- Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment(Baseline, week 32, and week 52)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, week 32, and week 52)
- Change From Baseline in ASDAS(CRP)(Baseline, week 32, and week 52)
- Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism(Baseline, week 32, and week 52)
- Percentage of Participants Achieving a BASDAI 50 Response(Baseline, week 32, and week 52)
- Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire(Baseline, week 32, and week 52)
- Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Presenteeism(Baseline, week 32, and week 52)
- Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)(Baseline, week 32, and week 52)
- Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index(Baseline, week 32, and week 52)
- Percentage of Participants Achieving ASDAS(CRP) Major Improvement(Baseline, week 32, and week 52)
- Percentage of Participants Achieving ASDAS(CRP) Clinically Important Improvement(Baseline, week 32, and week 52)
- Percentage of Participants With ASDAS Moderate Disease Activity(Week 32 and week 52)
- Percentage of Participants With ASDAS High Disease Activity(Week 32 and week 52)
- Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response(Baseline, week 32, and week 52)
- Percentage of Participants With ASDAS Inactive Disease at Week 52(Week 52)
- Percentage of Participants With ASDAS Low Disease Activity(Week 32 and week 52)
- Percentage of Participants With ASDAS Very High Disease Activity(Week 32 and week 52)
- Percentage of Participants Achieving an ASAS 40 Response(Baseline, week 32, and week 52)
- Change From Baseline in Swollen Joint Count(Baseline, week 32, and week 52)
- Percentage of Participants Achieving ASAS Partial Remission(Week 32 and week 52)
- Change From Baseline in Active Inflammation of the Sacroiliac Joints and Spine(Baseline and week 52)
- Change From Baseline in Physician's Global Assessment of Disease Activity(Baseline, week 32, and week 52)
- Change From Baseline in Patient's Global Assessment of Disease Activity(Baseline, week 32, and week 52)
- Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES)(Baseline, week 32, and week 52)
- Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin)(Baseline, week 32, and week 52)
- Change From Baseline in Patient's Global Assessment of Pain(Baseline, week 32, and week 52)
- Change From Baseline in Tender Joint Count(Baseline, week 32, and week 52)
- Change From Baseline in Dactylitis Count(Baseline, week 32, and week 52)
- Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)(Baseline, week 32, and week 52)
- Change From Baseline in C-reactive Protein (CRP)(Baseline, week 32, and week 52)
- Number of Participants With New Onset Anterior Uveitis(Up to Week 52)