Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,681
- 主要终点
- Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
研究概览
简要总结
The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.
详细描述
This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Participants with active, AS for at least 4 weeks (BASDAI greater than or equal to 4).
- •Participants who failed treatment with two non-steroidal anti-inflammatory drugs (NSAIDs).
- •No contraindications for anti-tumor necrosis factors (TNF) therapy.
排除标准
- •Participants who do not meet the above listed inclusion criteria.
结局指标
主要结局
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score
时间窗: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
The BASFI was a ten question, participant-reported measure that evaluated physical function. Each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment), and the MCID was 0.7. The mean of the ten questions was the total BASFI score. Data are reported as the mean change of total score from baseline (Month 0).
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
时间窗: At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months
The BASDAI was a six question, participant-reported measure of overall disease activity that probed the level of fatigue, neck/back/hip pain, peripheral joint swelling and pain, localized tenderness, as well as morning stiffness severity and duration. It was scored on a numerical rating scale that ranged from 0 (no symptoms) to 10 (severe symptoms), and the minimum clinically important difference (MCID) was 1.0. The final BASDAI score was calculated using the following equation, in which 01 - 06 represents the question number: (BASDAI01 + BASDAI02 + BASDAI03 + BASDAI04 + BASDAI05/2 + BASDAI06\*1.25/2)/5. The scale for question 6 was reduced to 0-8 since BASDAI06 was multiplied by 1.25. Data are reported as the mean change total score from baseline (Month 0).
Number of Participants With Drug-Related Adverse Events (AEs)
时间窗: From signing of informed consent up to 24 months
An adverse event/adverse experience was any reaction, side effect or other untoward event associated with the use of a drug in humans, whether or not the event was considered drug related. This included adverse events occurring from accidental or deliberate drug overdose, from drug abuse, or from drug withdrawal. Exacerbations of pre-existing conditions are also considered adverse events. Data presented are adverse events that are drug-related and are detailed in the adverse event section of this report.
次要结局
- Mean Plasma Concentrations of C-Reactive Protein (CRP)(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Global Assessment of Disease Activity Score(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants Who Missed Work Days Due to Ankylosing Spondylitis (AS) in the Previous 12 Months(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With Extraspinal Manifestations(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Erythrocyte Sedimentation Rate (ESR)(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Number of Involved Peripheral Joints(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Participant Pain Score(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With Morning Stiffness(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Duration of Morning Stiffness(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Equivalent Dose of Prednisolone(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Participant Fatigue Score(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants Achieving ASAS Partial Remission Criteria(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Days of In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants on Adalimumab Monotherapy(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Mean Bath Ankylosing Spondylitis-Global (BAS-G) Score(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) Improvement Criteria(At 3, 6, 9, 12, 18, and 24 months)
- Mean Missed Work Days Due to Ankylosing Spondylitis in the Previous 12 Months(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With In-Patient Hospitalization Due to Ankylosing Spondylitis in the Previous 12 Months(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With Concomitant Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)
- Percentage of Participants With Concomitant Pain Relief/Anti-Inflammatory Agents(At Baseline (Month 0), 3, 6, 9, 12, 18, and 24 months)