An Observational, Prospective, Multicenter, Local, to Assess the Quality of Life Through the Use of Questionnaires in a Cohort of Patients With Rheumatoid Arthritis Treated With Anti-CD20 Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24
研究概览
简要总结
This multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (RA) who are initiated with rituximab (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.
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 participants of both genders who are 18 years or older
- •Diagnosis of RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) of 1987 for the RA classification
- •Participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
- •Ability to meet the program's requirements and to voluntarily sign the Informed Consent Term.
排除标准
- •Participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
- •Participants with an active infection
- •Participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
- •Functional Class IV defined based on the ACR functionality criteria for RA
- •Participants who can not or who do not want, for any reason, to answer the questionnaires.
结局指标
主要结局
Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24
时间窗: Week 24
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of \>= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.
Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24
时间窗: Baseline and Week 24
SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.
次要结局
- Mean Change From Baseline in Tender Joint Count (TJC)(Baseline, Week 12, Week 24)
- Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline, Week 12, Week 24)
- Mean Change From Baseline in C-reactive Protein (CRP).(Baseline, Week 12, Week 24)
- Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score(Baseline, Week 12, Week 24)
- Mean Change From Baseline in Swollen Joint Count (SJC)(Baseline, Week 12, Week 24)
- Mean Change From Baseline in Patient Global Assessment (100 mm VAS)(Baseline, Week 12, Week 24)
- Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.(Up to 24 Weeks)
- Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change in SF-36 Physical and Mental Component Scores From Screening to Week 12(Baseline, Week 12)
- Change in HAQ Score From Screening to Weeks 12 and 24(Baseline, Week 12, Week 24)
- Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24(Baseline, Week 12, Week 24)
- Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.(Week 12)
- Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24.(Week 12 and 24)