A Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up
研究概览
简要总结
Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited.
Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice
Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia.
Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice.
Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N.
Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) -2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.
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
- •Adult patients (>18 years of age) with definite AS (as per modified New York criteria)
- •Coxitis with BASRI-hip score 0-2
- •Newly prescribed golimumab according to usual clinical practice
- •Naïve to anti-TNFs or other biologic agents prior to initiation of golimumab as indicated by the patient's medical records
- •Patient is enrolled after the investigator's decision to treat with golimumab, but before initiation of treatment with golimumab
- •Patient was informed of the benefits and risks of golimumab as per normal practice using the product leaflet
- •Signed informed consent form
排除标准
- •Any contraindication to golimumab in accordance to the label of Simponi®
- •BASRI-hip score 3-4
- •Any contraindication to MRI, e.g. previous hip joint replacement, heart pace maker.
研究组 & 干预措施
Golimumab injection
Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label.
干预措施: Golimumab Injection (Drug)
结局指标
主要结局
BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up
时间窗: From baseline to 12 months
The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment.
次要结局
- BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up(From baseline to 24 months)
- BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up(From baseline to 24 months)
- BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up(From baseline to 12 months)
- ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up(From baseline to 12 months)
- ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up(From baseline to 24 months)
- BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up(From baseline to 12 months)
- BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up(From baseline to 24 months)
- BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up(From baseline to 24 months)
- BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up(From baseline to 12 months)