NCT04517669已完成不适用
A Non-Interventional Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 116
- 试验地点
- 41
- 主要终点
- Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
研究概览
简要总结
This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period
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 must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Patients aged ≥ 18 years
- •Moderate to severe PsA disease activity diagnosed
- •Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
- •Patients are treatment naïve to tofacitinib on the date of providing informed consent
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
- •Patients on DMARDs must have not had a treatment change in the past 3 months
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
- •Receipt of any investigational drug within 3 months before study inclusion
- •Patient is pregnant or breastfeeding
- •Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
- •Active treatment for a malignancy
- •Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
结局指标
主要结局
Percentage of Participants Who Achieved Low Disease Activity (LDA) Based on Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
时间窗: At Month 6
PASDAS=composite disease activity measure for PsA which incorporated assessment of the following: participant global psoriatic arthritis assessment (PAA), physician global PAA, each scored on 100 mm visual analog scale (VAS), 0=no disease activity (DA), 100=maximum DA; tender joint count (TJC) (0-68); swollen joint count (SJC) (0-66); Leed's Enthesitis index (LEI) score ranging from 0-6; where 0=non tender, 6=more enthesitis burden; tender dactylitis digit score ranging from 0-3 where 0=no tenderness, 3=participant withdrew digit; physical component summary (PCS) of short form 36 (SF-36) score ranging from 0-100; where 0=severe physical health limitations and 100=excellent physical health and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS total score was calculated using a weighted formula and ranged from 0 (no disease) to 10 (severe disease); higher scores indicated more severe disease. LDA was defined as PASDAS score less than or equal to (\<=) 3.2.
次要结局
- Percentage of Participants Who Achieved LDA Based on PASDAS at Months 3 and 12(At Month 3 and Month 12)
- Percentage of Participants Who Achieved Minimum Disease Activity (MDA) at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Percentage of Participants Who Achieved Remission Based on PASDAS at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Percentage of Participants Who Achieved Remission Based on Disease Activity in Psoriatic Arthritis (DAPSA) Score at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Change From Baseline in Psoriatic Arthritis Impact of Disease 12 Questions (PsAID12) Score at Months 3, 6 and 12(Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12)
- Change From Baseline in Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC-EI) Score at Months 3, 6 and 12(Baseline (measurement at enrollment), at Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Body Mass Index (BMI) at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Treatment Line at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Duration of Current Episode Symptoms of at Least 6 Weeks Prior to Enrollment at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Erythrocyte Sedimentation Rate (ESR) Results at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to C-reactive Protein (CRP) Results at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Presence of Rheumatoid Nodules at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Presence of Unequivocal Radiological Erosion at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Presence of Unequivocal Bony Decalcification Localized to the Joints of the Hands and Wrists at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Presence of Symmetric Arthritis at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Arthritis of the Hand Joints at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Arthritis of Only 1 Medium-Large Joint at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Arthritis of 2-10 Medium-Large Joints and/or 1-3 Small Joints at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Arthritis of 4-10 Small Joints With or Without Involvement of Large Joints at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Number of Participants Who Achieved LDA According to Arthritis of >10 Joints (With at Least One Small Joint) at Months 3, 6 and 12(At Month 3, Month 6 and Month 12)
- Change From Baseline in Quality of Life (QoL) Based on Short Form 36 (SF-36) Score at Months 3, 6 and 12(Baseline (measurement at enrollment), Month 3, Month 6 and Month 12)
- Change From Baseline in QoL Based on Health Assessment Questionnaire - Disability Index (HAQ-DI41) at Months 3, 6 and 12(Baseline (measurement at enrollment), Month 3, Month 6 and Month 12)
研究者
研究点 (41)
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