Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
研究概览
简要总结
People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.
详细描述
Observational prospective study Purely descriptive
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
- •Patients who:
- •Are active RA patients (as judged by treating MD)
- •Are 18 years of age or older at time of consent
- •Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX
排除标准
- •Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
- •Participation in other clinical or observational trials
结局指标
主要结局
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
时间窗: Month 24
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
时间窗: Month 6
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
时间窗: Month 12
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
时间窗: Baseline
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
时间窗: Month 18
AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
次要结局
- Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)(Baseline, Month 6, 12, 18, 24)
- Visual Analog Scale (VAS) Fatigue Score(Baseline, Month 6, 12, 18, 24)
- Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)(Baseline, Month 6, 12, 18, 24)
- Health Assessment Questionnaire (HAQ) Total Score(Baseline, Month 6, 12, 18, 24)