About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Tirzepatide
DrugAdministered SC
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
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
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
Secondary outcomes
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Percentage of participants achieving TJC ≤1.
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Percentage of participants achieving SJC ≤1.
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Percentage of participants achieving BSA ≤3%.
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Sponsors and contacts
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