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NCT06864026 | RECRUITING | Psoriatic Arthritis

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)
Sponsor:

Eli Lilly and Company

Brief Summary:

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.

Condition or disease

Psoriatic Arthritis

Overweight or Obesity

Intervention/treatment

Tirzepatide

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
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.
Actual Study Start Date : 2025-03-06
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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)

Location Details

NCT06864026

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale

Avondale, Arizona, United States, 85392

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler

Chandler, Arizona, United States, 85225

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff

Flagstaff, Arizona, United States, 86001

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert

Gilbert, Arizona, United States, 85297

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

Glendale, Arizona, United States, 85306

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa

Mesa, Arizona, United States, 85210

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV

Phoenix, Arizona, United States, 85032

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City

Sun City, Arizona, United States, 85351

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson

Tucson, Arizona, United States, 85704

RECRUITING

United States, Arizona

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast

Tucson, Arizona, United States, 85748

RECRUITING

United States, California

Medvin Clinical Research - Apple Valley

Apple Valley, California, United States, 92307

RECRUITING

United States, California

Medvin Clinical Research - Covina

Covina, California, United States, 91722

RECRUITING

United States, California

Newport Huntington Medical Group

Huntington Beach, California, United States, 92648

RECRUITING

United States, California

Maletamt & Ekti Wine, Ins

The table, California, United States, 91942

RECRUITING

United States, California

Medvin Clinical Research - Riverside

Riverside, California, United States, 92508

RECRUITING

United States, California

Rheumatology Center of San Diego

San Diego, California, United States, 92128

NOT YET RECRUITING

United States, California

Providence Saint John's Medical Foundation

Santa Monica, California, United States, 90404

RECRUITING

United States, California

Medvin Clinical Research - Temecula

Theme, California, United States, 92592

RECRUITING

United States, California

Medvin Clinical Research - Tujunga

Tujunga, California, United States, 91042

RECRUITING

United States, California

Medvin Clinical Research - Whittier

Whittier, California, United States, 90602

RECRUITING

United States, Florida

Clinical Life Research

Kissimmee, Florida, United States, 34741

RECRUITING

United States, Florida

Life Clinical Trials

Margate, Florida, United States, 33063

RECRUITING

United States, Florida

CZ Rheumatology

Miami Beach, Florida, United States, 33140

RECRUITING

United States, Florida

Vitalia Medical Research

Palm Beach Gardens, Florida, United States, 33410

RECRUITING

United States, Florida

International Center for Research

Tampa, Florida, United States, 33614

NOT YET RECRUITING

United States, Florida

Conquest Research

Winter Park, Florida, United States, 32789

NOT YET RECRUITING

United States, Georgia

Atlanta Research Center for Rheumatology

Marietta, Georgia, United States, 30060

NOT YET RECRUITING

United States, Georgia

Satilla Rheumatology & Internal Medicine

Waycross, Georgia, United States, 31501

RECRUITING

United States, Illinois

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States, 60640

RECRUITING

United States, Illinois

Greater Chicago Specialty Physicians

Schaumburg, Illinois, United States, 60195

RECRUITING

United States, Illinois

Arnold Arthritis & Rheumatology

Skokie, Illinois, United States, 60076

RECRUITING

United States, Illinois

Willow Rheumatology and Wellness PLLC

Willowbrook, Illinois, United States, 60527

RECRUITING

United States, Indiana

Lake Cumberland Rheumatology

New Albany, Indiana, United States, 47150

RECRUITING

United States, Louisiana

Accurate Clinical Research, Inc

Lake Charles, Louisiana, United States, 70605

RECRUITING

United States, Maryland

Klein & Associates, M.D., P.A.

Cumberland, Maryland, United States, 21502

RECRUITING

United States, Maryland

Klein & Associates, M.D., P.A.

Hagerstown, Maryland, United States, 21740

RECRUITING

United States, Road cancer

Clinical Research Institute of Michigan, LLC

Saint Clair Shores, Road cancer, United States, 48081

RECRUITING

United States, Montana

Logan Health Rheumatology

Kalispell, Montana, United States, 59901

NOT YET RECRUITING

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

RECRUITING

United States, North Carolina

Onsite Clinical Solutions, LLC - Brenner Ave

Salisbury, North Carolina, United States, 28144

RECRUITING

United States, Ohio

Paramount Medical Research & Consulting, LLC

Middleburg Heights, Ohio, United States, 44130

RECRUITING

United States, Oklahola

Essential Medical Research

Tulsa, Okholohan, United States, 74137

RECRUITING

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

RECRUITING

United States, Tennessee

AARA Clinical Research - Murfreesboro Medical Clinic

Murfreesboro, Tennessee, United States, 37128

RECRUITING

United States, Texas

Precision Comprehensive Clinical Research Solutions - Colleyville

Colleyville, Texas, United States, 76034

RECRUITING

United States, Texas

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth

Fort Worth, Texas, United States, 76109

RECRUITING

United States, Texas

Accurate Clinical Research, Inc

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

Research Physicians Network, LLC

Houston, Texas, United States, 77089

RECRUITING

United States, Texas

AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving

Irving, Texas, United States, 75039

RECRUITING

United States, Texas

Biopharma Informatic, LLC

Katy, Texas, United States, 77494

NOT YET RECRUITING

United States, Texas

SouthWest Rheumatology Research, LLC

Mesquite, Texas, United States, 75150

RECRUITING

United States, Texas

Advanced Rheumatology of Houston - Woodlands

The Woodlands, Texas, United States, 77382

RECRUITING

United States, Texas

DM Clinical Research - TRA

Tomball, Texas, United States, 77375

RECRUITING

United States, Washington

Seattle Rheumatology Associates PLLC

Seattle, Washington, United States, 98104

RECRUITING

United States, Washington

Arthritis Northwest, PLLC

Spocane, Washington, United States, 99204

RECRUITING

Puerto Rico,

Reuviva Research Center

Guaynabo, Puerto Rico, 00968

RECRUITING

Puerto Rico,

Caribbean Medical Research Center

San Juan, Puerto Rico, 00918