A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA)

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат Tirzepatide
  Administered SC

Первичные конечные точки

• Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy [Срок оценки: 12 Months]
• Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy [Срок оценки: 12 Months]

Вторичные конечные точки (12)

• Percentage of Participants Achieving Tender Joint Count (TJC) ≤1 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Body Surface Area (BSA) ≤3% [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2 [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss [Срок оценки: Month 6 and Month 12]
• Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline [Срок оценки: Month 6 and Month 12]
• Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID) [Срок оценки: Month 6 and Month 12]
• Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID [Срок оценки: Month 6 and Month 12]
• Percentage of Participants Achieving a HAQ-DI score ≤0.5 [Срок оценки: Month 6]
• Percentage of Participants with ≥10% Weight Loss at Month 6 [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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 2.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 53 центра

• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale — Avondale
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler — Chandler
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff — Flagstaff
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert — Gilbert
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale — Glendale
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa — Mesa
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV — Phoenix
• AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City — Sun City
• … и ещё 45 центров

Пуэрто-Рико · 2 центра

• Reuviva Research Center — Guaynabo
• CMRC Headlands, LLC — San Juan

Идентификаторы

NCT: NCT06864026 · 27350 · I1F-MC-RHDE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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