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)

Description

The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

Conditions

Psoriatic Arthritis, Overweight or Obesity

Study Overview

Study Details

Study 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 moderate-to-severe PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.

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.

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)

Condition
Psoriatic Arthritis
Intervention / Treatment

-

Contacts and Locations

Avondale

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale, Avondale, Arizona, United States, 85392

Chandler

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler, Chandler, Arizona, United States, 85225

Flagstaff

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff, Flagstaff, Arizona, United States, 86001

Gilbert

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert, Gilbert, Arizona, United States, 85297

Glendale

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale, Glendale, Arizona, United States, 85306

Mesa

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa, Mesa, Arizona, United States, 85210

Phoenix

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV, Phoenix, Arizona, United States, 85032

Sun City

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City, Sun City, Arizona, United States, 85351

Tucson

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson, Tucson, Arizona, United States, 85704

Tucson

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast, Tucson, Arizona, United States, 85748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-01