A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
研究概览
简要总结
This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start 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
- •Severe RA.
- •Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
- •Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.
排除标准
- •Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
- •Previous tocilizumab treatment in a clinical trial or for compassionate use.
- •Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
- •History of autoimmune disease or any joint inflammatory disease other than RA.
结局指标
主要结局
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
时间窗: Baseline
TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
C-Reactive Protein (CRP) at Baseline
时间窗: Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
时间窗: Month 6
Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100.
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
时间窗: Baseline
Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
Physician Global Assessment of Disease Activity Using VAS at Baseline
时间窗: Baseline
Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.
Patient Global Assessment of Disease Activity Using VAS at Baseline
时间窗: Baseline
The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.
Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
时间窗: Baseline
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Erythrocyte Sedimentation Rate (ESR) at Baseline
时间窗: Baseline
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.
次要结局
- Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change(Baseline up to Month 6)
- Percentage of Participants With Reasons Who Discontinued Tocilizumab(Baseline up to Month 6)
- Percentage of Participants by Reason for Choice of Monotherapy at Baseline(Baseline up to Month 6)
- Duration of Tocilizumab Treatment(Baseline up to Month 6)
- Mean Dosing Interval at Month 6(Month 6)
- Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6(Baseline, Month 6)
- Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit(Baseline, Month 3, Month 6)
- Time to Restoration of Initial Dosing Regimen(Baseline up to Month 6)
- Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs(Baseline)
- Simplified Disease Activity Index (SDAI) Score by Visit(Baseline, Month 3, Month 6)
- Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6(Baseline, Month 3, Month 6)
- Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6(Baseline, Month 3, Month 6)
- Percentage of Participants With and Without Morning Stiffness(Baseline, Month 3, Month 6)
- Percentage of Participants Adhering to Local Label for Adverse Events(Baseline up to Month 6)
- Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6(Month 3 and Month 6)
- Clinical Disease Activity Index (CDAI) Score by Visit(Baseline, Month 3, Month 6)
- Change From Baseline in TJC and SJC at Month 3 and Month 6(Baseline, Month 3, Month 6)
- Change From Baseline in VAS-Fatigue at Months 3 and 6(Baseline, Month 3, Month 6)
- Change From Baseline in Patient's Assessment of Pain at Months 3 and 6(Baseline, Month 3, Month 6)
- Median Dose at Month 6(Month 6)
- Percentage of Participants by Duration of Morning Stiffness(Baseline, Month 3, Month 6)
- Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6(Baseline, Month 3, Month 6)
- Change From Baseline in HAQ-DI Score at Months 3 and 6(Baseline, Month 3, Month 6)
- Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment(Month 3 and Month 6)