A Phase 4, Prospective, Open-Label, Single-Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 154
- 主要终点
- Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
研究概览
简要总结
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with active PsA and obesity or overweight with at least 1 weight-related comorbidity.
The study will last up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 diagnosis of active psoriatic arthritis (PsA) as defined by a rheumatologist or other healthcare professional (HCP) experienced in treating PsA.
- •Body Mass Index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m2 to <30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
- •Who have been treated with ixekizumab for approximately 3 months (±1 month) prior to decision to add tirzepatide.
- •Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline or screening).
排除标准
- •Have currently received ixekizumab for more than 4 months or less than 2 months.
- •Had any exposure to tirzepatide or other glucagon-like peptide-1 (GLP-1) receptor agonist (for example, dulaglutide, liraglutide, or semaglutide).
- •Are currently enrolled in any other clinical study.
- •Have a known hypersensitivity to any component of tirzepatide.
- •Have a personal or family history of medullary thyroid cancer.
- •Have multiple endocrine neoplasia type
- •Have type 1 diabetes mellitus.
- •Have a history of chronic or acute pancreatitis at any time before screening.
- •Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.
- •Have a history of ketoacidosis or hyperosmolar state/coma.
- •Have a history of severe hypoglycemia unawareness within the 6 months before screening.
- •Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/vomiting.
研究组 & 干预措施
Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
时间窗: 12 Months
The HAQ-DI is a patient-reported outcome questionnaire that is used to measure disease associated disability as an assessment of physical function. It consists of 20 questions referring to 8 domains of functioning. Participants assess their degree of difficulty when performing the activities over the past week on a 4-item ordinal scale, ranging from 0, "without any difficulty," to 3, "unable to do." The scores of each of the 8 domains are summed and divided by 8. Higher scores indicate more limitations in physical function.
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
时间窗: 12 Months
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
次要结局
- Percentage of Participants Achieving Tender Joint Count (TJC) ≤1(Month 6 and Month 12)
- Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1(Month 6 and Month 12)
- Percentage of Participants Achieving Body Surface Area (BSA) ≤3%(Month 6 and Month 12)
- Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2(Month 6 and Month 12)
- Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15(Month 6 and Month 12)
- Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2(Month 6 and Month 12)
- Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss(Month 6 and Month 12)
- Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline(Month 6 and Month 12)
- Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)(Month 6 and Month 12)
- Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID(Month 6 and Month 12)
- Percentage of Participants Achieving a HAQ-DI score ≤0.5(Month 6)
- Percentage of Participants with ≥10% Weight Loss at Month 6(Month 6)
- Mean Percent Change of Weight from Baseline(Baseline, Month 6 and Baseline, Month 12)