Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Discontinued Treatment With Etanercept
研究概览
简要总结
Previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. In this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week Study (LoadET, 0881A3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with AS refractory to conventional therapy. The interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with AS. Once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice.
The objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the LoadET study. Therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the LoadET Study (0881A3-102090) and now. This will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the LoadET study (0881A3 102090).
详细描述
Given that this is a follow-up study of subjects who participated in the LoadET study (0881A3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the LoadET study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •AS patients who had previously participated in the LoadET study (0881A3-102090).
- •Subjects who completed the LoadET Study.
- •Patients who grant their informed consent
排除标准
- •Patients who participated in the LoadET study but who discontinued treatment and, therefore, did not complete the study.
- •Patients without standard follow-up by the physician since the end of the study.
结局指标
主要结局
Percentage of Participants Who Discontinued Treatment With Etanercept
时间窗: Baseline up to Year 3
Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.
次要结局
- Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist(Baseline)
- Time to Diagnosis of Ankylosing Spondylitis(Baseline)
- Number of Participants Who Received Non-pharmacological Treatment(Baseline up to Year 3)
- Number of Participants Who Received Pharmacological Treatment(Baseline up to Year 3)
- Patient Global Assessment (PtGA) of Disease Activity Score(Baseline, Year 1, 2, 3)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Year 1, 2, 3)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Year 1, 2, 3)
- Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Year 1, 2, 3)
- Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Year 1, 2, 3)
- Modified Schober's Test(Baseline, Year 1, 2, 3)
- Occiput-to-wall Distance(Baseline, Year 1, 2, 3)
- Chest Expansion Measurement(Baseline, Year 1, 2, 3)
- C-reactive Protein (CRP)(Baseline, Year 1, 2, 3)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Year 1, 2, 3)
- Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels(Baseline, Year 1, 2, 3)
- Time to Treatment Discontinuation With Etanercept(Year 3)