NCT02505542已完成3 期
A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 736
- 试验地点
- 124
- 主要终点
- Percentage of Participants in Part B Who Did Not Experienced a Flare
研究概览
简要总结
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
- •Active disease at Screening as defined by
- •Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
- •Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
- •Spinal pain > 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
- •for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) > upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
- •Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
排除标准
- •Presence of total Spinal Ankylosis ('bamboo spine')
- •Diagnosis of any other Inflammatory Arthritis
- •Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
- •Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
- •History of or current chronic or recurrent infections
- •High risk of infection
- •Recent live vaccination
- •Concurrent malignancy or a history of malignancy
- •Class III or IV congestive heart failure - New York Heart Association (NYHA)
- •Demyelinating disease of the central nervous system
- •Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
- •Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
结局指标
主要结局
Percentage of Participants in Part B Who Did Not Experienced a Flare
时间窗: From Week 48 to Week 96
A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (\>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (\<) 1.3 at Week 32 or Week 36 (if ASDAS \< 1.3 at Week 32, it must have been \< 2.1 at Week 36; if ASDAS \< 2.1 at Week 32, it must have been \< 1.3 at Week 36) and an ASDAS \< 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.
次要结局
- Time to Flare in Part B(From Week 48 to Week 96)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B(Week 96)
- Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B(Week 96)
- Percentage of Participants Achieving Sustained Remission at Week 48 in Part A(Week 48)
- Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B(Week 96)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B(From Week 48 to Week 96)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B(From Week 48 to Week 96)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B(From Week 48 to Week 96)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A(Week 48)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A(Week 48)
- Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B(Week 96)
- Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B(Week 96)
- Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B(Week 96)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B(From Week 48 to Week 96)
- Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B(Week 96)
- Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B(From Week 48 to Week 96)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B(From Week 48 to Week 96)
- Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study(From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication))
- Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B(Escape Week 12)
- Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B(From time of flare to Escape Week 12)
- Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study(From Screening Period (Week -5 to Week -1) until Week 48)
- Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study(From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication))
- Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study(From time of flare to Escape Week 12)
- Certolizumab Pegol (CZP) Plasma Concentration During the Study(From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication))
研究者
研究点 (124)
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