Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 84
- 试验地点
- 24
- 主要终点
- Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12
研究概览
简要总结
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.
详细描述
The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status.
This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups.
In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop-out rate of 30% over 1 year period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with AS who start treatment with Etanercept according to prevailing reimbursement criteria and dosing in line with SmPC.
- •First cohort: Etanercept is the first biological product prescribed
- •Second cohort: Etanercept is the second biological product prescribed
- •Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
- •18 years of age or older at time of consent
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
研究组 & 干预措施
Etanercept First
Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium
干预措施: etanercept (Drug)
Etanercept second
Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium
干预措施: etanercept (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASAS 60 was defined as at least \>= 60 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASAS 40 was defined as at least \>= 40 percent relative improvement from baseline and an absolute change \>=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASAS partial remission was defined as a score of less than or equal to (\<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASAS 5/6 was defined as at least greater than or equal to (\>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.
Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least \>=50 percent relative improvement from baseline in BASDAI total score.
Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12
时间窗: Month 6 up to Month 12
ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of \<1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.
次要结局
- Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12(Month 3, 6, 9 and 12)
- Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12(Baseline, Month 6 and12)
- Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Spinal Mobility Measurement at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12(Baseline, Month 6 and 12)