Psoriatic Arthritis Research Collaborative: Biologic Sub-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 4
- 主要终点
- Patient Function Response to Biologic Therapy as Measured by RAPID3
研究概览
简要总结
Psoriatic arthritis (PsA) is an inflammatory arthritis with substantial variation in clinical features. We propose a multicenter collaborative approach to better understand the phenotypes and current management of PsA in the United States.The central goal of this proposal is to obtain the data necessary to design a pragmatic trial in PsA.
详细描述
Psoriatic arthritis (PsA) is a chronic inflammatory arthritis that can be associated with devastating outcomes including irreversible joint damage. The management of a patient with PsA is extremely challenging due to the high degree of phenotypic heterogeneity. The ultimate goal of this proposal is to prepare pragmatic trials in PsA trials that will encompass all relevant subgroups of patients. The aims of this study specifically focus on responses to biologic therapy among patients with PsA and determining the optimal set of outcome measures for PsA trials.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-89
- •Active PsA (at least one swollen joint or enthesitis) -Meet CASPAR criteria (Table 2) (103) -Initiation of TNFi (etanercept, adalimumab, infliximab, certolizumab, golimumab) (At the time of the submission, TNFi biosimilars have been approved by the FDA but are not available on the US market. Once available, patients starting TNFi biosimilars will similarly be eligible for participation. Patients may have been on the medication in the past but must have had greater than 2 months off the medication.Patients may be taking other traditional DMARDs. A washout period is not required.)
排除标准
- •Unable to give informed consent
- •Out of the age range
- •Switching therapies for skin psoriasis in the setting of well controlled joint and enthesis symptoms.
- •Patients with only active PsA
结局指标
主要结局
Patient Function Response to Biologic Therapy as Measured by RAPID3
时间窗: 3 Months
Patient's perception of response to therapy as related to patient functionality. Measured by a change in RAPID3 score from baseline to 3 month visit. RAPID3 (Routine Assessment of Patient Index Data 3) is a pooled index of the 3 patient-reported American College of Rheumatology Core Data Set measures: function, pain, and patient global estimate of status. Each of the 3 individual measures is scored 0 to 10, for a total of 30. Disease severity may be classified on the basis of RAPID3 scores: \>12 = high; 6.1-12 = moderate; 3.1-6 = low; \< or =3 = remission.
次要结局
- Patient Function Response to Biologic Therapy as Measured by HAQ-DI(3 Months)
- Patient Quality of Life Response to Biologic Therapy as Measured by PROMIS10(3 Months)
- Patient Quality of Life Response to Biologic Therapy as Measured by PSAID(3 Months)
- Physician Assessment of Disease Response to Biologic Therapy as Measured by Swollen Joint Count.(3 Months)
- Physician Assessment of Disease Response to Biologic Therapy as Measured by Tender Joint Count.(3 Months)
- Disease Activity and Response to Biologic Therapy as Measured by Patient Pain Assessment(3 Months)
- Disease Activity and Response to Biologic Therapy as Measured by Physician Global Assessment(3 Months)
- Disease Activity and Response to Biologic Therapy as Measured by Patient Global Assessment(3 Months)