PATIENT-REPORTED OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB OR BIOLOGICAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN REAL LIFE CONDITIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 170
- 试验地点
- 13
- 主要终点
- Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
研究概览
简要总结
This study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in Latin-American patients with Rheumatoid Arthritis (RA) treated with tofacitinib or biological DMARDs after failure to respond to conventional DMARDs in real-life conditions. This will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic DMARD treatments in patients with RA after failure of conventional DMARDs. The population will be composed by adult patients over 18 years of age diagnosed with RA and who have been prescribed tofacitinib or any biological DMARDs.
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
- •Patients ≥ 18 years of age at the time of recruitment
- •Patient diagnosed with moderate to severe RA ≥ 6 months before enrollment
- •Patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional DMARDs for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study
- •Patients with no biological DMARDs use in patient history.
- •Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at doses established in ACR guidelines published in 2015 and following medical criteria.
- •Acceptance for patients to participate in the study and signing of the informed consent.
排除标准
- •Patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers.
- •Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's syndrome.
- •Patients treated with biological DMARDs in monotherapy.
- •Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation.
- •Patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
结局指标
主要结局
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Score at Month 6
时间窗: Baseline, Month 6
Disease activity was assessed using RAPID3, which was based on participant-reported multi-dimensional health assessment questionnaire (MDHAQ). RAPID3 included 3 core data set measures of physical function, pain, and patient global estimate. Physical function=mean of scores from 10 individual questions on activities of daily living (each question scored from '0'=no difficulty to '3'=much difficulty), scores were transformed to give a total score=0 to 10, higher scores=greater difficulty. Pain and global estimate of health measured on Likert scale from '0'=no pain/feeling very well to '10'=pain as bad as it could be/ feeling very poorly, higher scores=greater difficulty/ worsening of condition. RAPID3 composite score: mean of physical function, pain, and global assessment scores, ranging from 0 to 10, higher values=greater disease activity. Data has been provided in terms of adjusted (consider impact of co-variables) and unadjusted mean (does not consider co-variables impact).
次要结局
- Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6(Baseline, Month 6)
- Number of Participants Who Withdrew From Study Due to Adverse Events And Due to All Causes(Baseline up to Month 6)
- Change From Baseline in Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6(Baseline, Month 6)
- European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6(Month 6)
- Change From Baseline in European Quality of Life- 5 Dimension-3 Levels (EQ-5D-3L) Index Score at Month 6(Baseline, Month 6)
- Disease Activity Score Based on 28-joints Count (DAS28) at Month 6(Month 6)
- Adapted Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6(Month 6)
- Number of Participants With Serious Infections(Baseline up to Month 6)
- Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6(Month 6)
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Rheumatoid Arthritis (WPAI:RA) Scores at Month 6(Baseline, Month 6)
- Number of Participants With Serious Adverse Event (SAE) and Non-serious Adverse Events (AEs)(Baseline up to Month 6)