Clinical trial

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)

Recruiting now · Phase 4 · 2 countries · Registry ID NCT06864026

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionPsoriatic Arthritis, Overweight or Obesity

Full registry 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.

Treatments and study arms

Tirzepatide

Drug

Administered SC

Primary outcomes

Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy12 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 Therapy12 Months

Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.

Study locations

55 locations were listed when this page was built. The first 40 are shown.

Reuviva Research Center🇵🇷 Guaynabo, Puerto Rico