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Recruiting NCT06864026

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)

Phase IV Interventional Psoriatic Arthritis Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide.
Who it may be relevant to
Registry conditions: Psoriatic Arthritis, Overweight or Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Puerto Rico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Drug Tirzepatide
    Administered SC

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 53 centers
  • 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
  • … and 45 more centers
Puerto Rico · 2 centers
  • Reuviva Research Center — Guaynabo
  • CMRC Headlands, LLC — San Juan

Identifiers

NCT: NCT06864026 · 27350 · I1F-MC-RHDE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗