Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 主要终点
- Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
研究概览
简要总结
The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.
详细描述
This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
研究设计
- 研究类型
- Observational
- 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
- •Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines
- •Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment
- •Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines
- •Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
排除标准
- •Was unable to walk either due to RA or a comorbid condition
- •Was unable to perform basic self-care activities
- •Had contraindications for treatment with adalimumab
结局指标
主要结局
Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
时间窗: Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
次要结局
- Mean Change From Baseline in SQUASH-B Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in SQUASH-D Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in SQUASH-C Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)(Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Total Physical Activity SQUASH Score(Month 3, Month 6 and Month 9)
- Mean Change From Baseline in SQUASH-A Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Percentage of Participants in Clinical Disease Remission (DAS28<2.6)(Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores(Month 0 and Month 12 LOCF)
- Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores(Month 0 and Month 12 LOCF)
- Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender(Month 0 and Month 12 LOCF)
- Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories(Month 0 and Month 12 LOCF)
- Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education(Month 0 and Month 12 LOCF)
- Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation(Month 0 and Month 12 LOCF)