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 · NCT06864026 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
55 locations listed across 17 US states.
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale - Avondale, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler - Chandler, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff - Flagstaff, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert - Gilbert, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale - Glendale, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa - Mesa, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV - Phoenix, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City - Sun City, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson - Tucson, Arizona, United States
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast - Tucson, Arizona, United States
- Medvin Clinical Research - Apple Valley - Apple Valley, California, United States
- Medvin Clinical Research - Covina - Covina, California, United States
- Newport Huntington Medical Group - Huntington Beach, California, United States
- Purushotham & Akther Kotha MD, Inc - La Mesa, California, United States
- Medvin Clinical Research - Riverside - Riverside, California, United States
- Rheumatology Center of San Diego - San Diego, California, United States
- Providence Saint John's Medical Foundation - Santa Monica, California, United States
- Medvin Clinical Research - Temecula - Temecula, California, United States
- Medvin Clinical Research - Tujunga - Tujunga, California, United States
- Medvin Clinical Research - Whittier - Whittier, California, United States
- Vida Clinical Research - Kissimmee, Florida, United States
- Life Clinical Trials - Margate, Florida, United States
- CZ Rheumatology - Miami Beach, Florida, United States
- Vitalia Medical Research - Palm Beach Gardens, Florida, United States
- International Center for Research - Tampa, Florida, United States
- Atlanta Research Center for Rheumatology - Marietta, Georgia, United States
- Satilla Rheumatology & Internal Medicine - Waycross, Georgia, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- Greater Chicago Specialty Physicians - Schaumburg, Illinois, United States
- Arnold Arthritis & Rheumatology - Skokie, Illinois, United States
- Willow Rheumatology and Wellness PLLC - Willowbrook, Illinois, United States
- Lake Cumberland Rheumatology - New Albany, Indiana, United States
- Accurate Clinical Research, Inc - Lake Charles, Louisiana, United States
- Klein & Associates, M.D., P.A. - Cumberland, Maryland, United States
- Klein & Associates, M.D., P.A. - Hagerstown, Maryland, United States
- Clinical Research Institute of Michigan, LLC - Saint Clair Shores, Michigan, United States
- Logan Health Rheumatology - Kalispell, Montana, United States
- University of Rochester Medical Center - Rochester, New York, United States
- Onsite Clinical Solutions, LLC - Brenner Ave - Salisbury, North Carolina, United States
- Paramount Medical Research & Consulting, LLC - Middleburg Heights, Ohio, United States
- Essential Medical Research - Tulsa, Oklahoma, United States
- West Tennessee Research Institute - Jackson, Tennessee, United States
- AARA Clinical Research - Murfreesboro Medical Clinic - Murfreesboro, Tennessee, United States
- Precision Comprehensive Clinical Research Solutions - Colleyville - Colleyville, Texas, United States
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth - Fort Worth, Texas, United States
- Accurate Clinical Research, Inc - Houston, Texas, United States
- Research Physicians Network, LLC - Houston, Texas, United States
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving - Irving, Texas, United States
- Biopharma Informatic, LLC - Katy, Texas, United States
- Advanced Rheumatology of Houston - Woodlands - The Woodlands, Texas, United States
- DM Clinical Research - TRA - Tomball, Texas, United States
- Seattle Rheumatology Associates PLLC - Seattle, Washington, United States
- Arthritis Northwest, PLLC - Spokane Valley, Washington, United States
- Reuviva Research Center - Guaynabo, Puerto Rico
- CMRC Headlands, LLC - San Juan, Puerto Rico