A Prospective, Mono-Country, Multi-Center Study to Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis Patients on Adalimumab Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 主要终点
- Frequency of Extra-Axial Manifestations (EAMs) of Interest
研究概览
简要总结
This was a prospective mono-country, multi-center study of the frequency of extra-axial manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in routine clinical practice.
详细描述
A baseline assessment was performed prior to the first dose of adalimumab. Participants received 40 mg of adalimumab every other week for one year. Study visits were conducted at 12, 28, 36 and 52 weeks. All participants were to have one follow-up approximately 70 days after the last dose of adalimumab.
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
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥19 years of age
- •Participant has been diagnosed with ankylosing spondylitis (AS) according to the 1984 modified New York criteria for at least 3 months
- •Participant has active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4, despite treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) or with disease-modifying antirheumatic drugs (DMARDs) for more than 3 months based on Korea AS reimbursement guideline
- •Participant is eligible for adalimumab in daily rheumatologic practice
- •Participant must provide written authorization form to use personal and/or health data prior to the entry into the study
排除标准
- •Female participants who are pregnant or breastfeeding
- •Participants who are contraindicated to any anti-tumor necrosis factor (TNF) agent
- •Participant is enrolled in other clinical trials
研究组 & 干预措施
Participants with Ankylosing Spondylitis
Adalimumab 40 mg every other week by subcutaneous (SC) injection for 52 weeks
干预措施: Adalimumab (Drug)
结局指标
主要结局
Frequency of Extra-Axial Manifestations (EAMs) of Interest
时间窗: Baseline
The baseline assessment was performed prior to the first dose of adalimumab. The presence of peripheral arthritis (arthritis affecting shoulders, elbows, wrists, hands, knees, ankles, feet), enthesitis (inflammation of the areas where ligaments or tendons insert into bone) and dactylitis (inflammation of finger and/or toe joints) was noted. Peripheral arthritis was defined as ≥1 swollen joint on the Swollen Joint Count scale (SJC; range, 0 to 44, excluding hip joints). Enthesitis was defined as at least one inflamed enthesis in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0 to 13, with higher scores representing more severe disease) or of the plantar fascia of the foot. Dactylitis was measured by a simple count of dactylitic digits.
次要结局
- Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response(Baseline, Week 12, Week 28, Week 36, Week 52)
- Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline(Baseline, Week 12, Week 28, Week 36, Week 52)
- Proportion of Participants With Enthesitis of the Plantar Fascia(Baseline, Week 12, Week 28, Week 36, Week 52)
- Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline(Baseline, Week 12, Week 28, Week 36, Week 52)
- Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline(Baseline, Week 12, Week 28, Week 36, Week 52)
- Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline(Baseline, Week 12, Week 28, Week 36, Week 52)