A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 主要终点
- Dosing Interval Between the Infliximab Infusions
研究概览
简要总结
This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.
详细描述
Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
排除标准
- •episodic treatment with infliximab
研究组 & 干预措施
RA patients
Patients on maintenance therapy for RA with infliximab for >= the past 12 months.
干预措施: Infliximab (Drug)
结局指标
主要结局
Dosing Interval Between the Infliximab Infusions
时间窗: Measured from the Remicade Questionnaire at first (and only) study visit
Patients were asked as part of the Remicade questionnaire what dosing interval they were on.
Reason for Extending Dosing Interval
时间窗: Measured from the Remicade Questionnaire at first (and only) study visit
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.
Patient Response to Increased Dosing Interval
时间窗: Measured from the Remicade Questionnaire at first (and only) study visit
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?" Those who noticed a difference were asked if their experience was positive or negative.
Number of Patients Agreeing to Participate in a Dose Reduction Study
时间窗: Measured from the Remicade Questionnaire at first (and only) study visit
As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"
次要结局
- Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.(Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.)
- Adverse Events (AEs)(Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.)
- Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.(Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.)