NCT07532226招募中不适用
A Real-World, Prospective Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of Participants Still Receiving Treatment at 1 Year
研究概览
简要总结
This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).
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
- •Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR)
- •Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study
- •Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication
- •The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations
- •Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements
排除标准
- •Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment.
- •Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase [JAK] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time
- •Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis)
- •Unwilling or unable to participate in long-term data collection
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study ( that is, signing of informed consent)
- •Currently enrolled in any interventional study or any Janssen-Cilag France-sponsored observational clinical study
- •Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization
研究组 & 干预措施
Group 1: Psoriatic Arthritis Participants Treated With Guselkumab
Participants with confirmed diagnosis of psoriatic arthritis treated with guselkumab as per routine clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study.
结局指标
主要结局
Proportion of Participants Still Receiving Treatment at 1 Year
时间窗: At 1 year
Discontinuation or maintenance of guselkumab treatment will be recorded by the physician at each visit. Proportion of participants still receiving treatment will be reported in the outcome measure.
Percentage of Participants Still Receiving Treatment at Persistence Time
时间窗: Up to 8 weeks
Persistence time of the initial treatment: defined as the time from the date of the first administration of guselkumab to the date that the last dose of guselkumab treatment was administered plus 1 dosing interval (8 weeks), or until start of subsequent treatment.
Number of Participants Starting New Treatment
时间窗: At 1 year
Participants starting new treatment along with reason of discontinuation will be reported.
次要结局
- Percentage of Participants Still Receiving Treatment at 2 years(At 2 years)
- Percentage of Participants Discontinuing The Treatment(At 2 years)
- Change From Baseline in Disease Activity Index in Psoriatic Arthritis (DAPSA)/ Clinical Disease Activity Index in Psoriatic Arthritis (cDAPSA)(Baseline, Months 3,6,12,18, and 24)
- Change From Baseline in Leeds Enthesitis Index (LEI) Score(Baseline, Months 3,6,12,18, and 24)
- Change From Baseline in Back and Neck Pain Numerical Rating Scale (NRS) Score(Baseline, Months 3,6,12,18, and 24)
- Hazard Ratios Between Baseline Clinical Factors and Guselkumab Persistence and Effectiveness at Months 12 and 24(At Month 12 and 24)
- Sociodemographic Characteristics: Age(At Baseline)
- Sociodemographic Characteristics: Sex(At Baseline)
- Sociodemographic Characteristics: Weight(At Baseline)
- Sociodemographic Characteristics: Height(At Baseline)
- Sociodemographic Characteristics: Body Mass Index (BMI)(At Baseline)
- Number of Participants Reporting Smoking, Cannabis and Alcohol Use(At Baseline)
- Number of Participants With Family History of Psoriasis and/or Psoriatic Arthritis and/or Spondyloarthritis(At Baseline)
- Date of Diagnosis of Psoriatic Arthritis(At Baseline)
- Date of Previous Treatments of Psoriatic Arthritis(At Baseline)
- Duration of Previous Treatments of Psoriatic Arthritis(At Baseline)
- Medical History and Current Situation(At Baseline)
- Number of Participants Receiving Co-occurring Treatments Linked to Psoriatic Arthritis(Baseline up to 2 Years)
- Failure to Achieve or Maintain Response(Up to 2 Years)
- Number of Participants Reporting Problems Related to the Management of Signs and Symptoms(At baseline)
- Evidence of Persistent Disease(Up to 2 Years)
- Number of Participants with Co-Morbidities(At baseline)
- Number of Participants with Abnormal Psychosocial Factors(At Baseline)
- Healthcare Professional (HCP): Age Group(At Baseline)
- HCP: Sex(At Baseline)
- HCP: Experience(At Baseline)
- HCP: Type of Practice(At Baseline)
- Number of Participants With Adverse Events, Serious Adverse Events, Infections and Injection Site Reactions(Up to 2 Years)
- Tolerance Related Guselkumab Treatment(Up to 2 Years)
- Dose at Initiation of Guselkumab(At Months 0, 3, 6, 12, 18 and 24)
- Treatment Interval at Initiation of Guselkumab(At Months 0, 3, 6, 12, 18 and 24)
- Type of Injection(At Months 0, 3, 6, 12, 18 and 24)
- Number of Participants Reporting Change of Injection Frequency(At Months 0, 3, 6, 12, 18 and 24)
- Number of Participant With Co-occurring Treatments Linked to PSA(At Months 0, 3, 6, 12, 18 and 24)
- Number of Participants With Reason for Choosing Guselkumab From the Therapeutic Arsenal(At Months 0, 3, 6, 12, 18 and 24)
- Number of Participants Switching to New Treatment in Case of Discontinuation of Guselkumab Treatment(At Months 0, 3, 6, 12, 18 and 24)
- Change From Baseline in 12-item Psoriatic Arthritis Impact of Disease Questionnaire (PsAID-12) Questionnaire Score(Baseline, Months 0, 3, 6, 12, 18 and 24)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Each Visit After Baseline(Baseline, Months 0, 3, 6, 12, 18 and 24)
- Satisfaction of Treatment for the Participants(At Months 3, 6, 12, 18 and 24)
- Satisfaction of Treatment Care Management and Patient Relationship for the Rheumatologist(At Months 3, 6, 12, 18 and 24)
研究者
研究点 (1)
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