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.
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 active PsA and obesity or overweight with at least 1 weight-related comorbidity. The study will last up to 12 months.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
RECRUITING
Avondale
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
RECRUITING
Chandler
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
ACTIVE_NOT_RECRUITING
Flagstaff
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
COMPLETED
Gilbert
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
ACTIVE_NOT_RECRUITING
Glendale
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
ACTIVE_NOT_RECRUITING
Mesa
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
RECRUITING
Phoenix
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
ACTIVE_NOT_RECRUITING
Sun City
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
ACTIVE_NOT_RECRUITING
Tucson
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
RECRUITING
Tucson
California
Medvin Clinical Research - Apple Valley
ACTIVE_NOT_RECRUITING
Apple Valley
Medvin Clinical Research - Covina
COMPLETED
Covina
Newport Huntington Medical Group
ACTIVE_NOT_RECRUITING
Huntington Beach
Purushotham & Akther Kotha MD, Inc
ACTIVE_NOT_RECRUITING
La Mesa
Medvin Clinical Research - Riverside
ACTIVE_NOT_RECRUITING
Riverside
Rheumatology Center of San Diego
ACTIVE_NOT_RECRUITING
San Diego
Providence Saint John's Medical Foundation
ACTIVE_NOT_RECRUITING
Santa Monica
Medvin Clinical Research - Temecula
ACTIVE_NOT_RECRUITING
Temecula
Medvin Clinical Research - Tujunga
RECRUITING
Tujunga
Medvin Clinical Research - Whittier
ACTIVE_NOT_RECRUITING
Whittier
Florida
Vida Clinical Research
ACTIVE_NOT_RECRUITING
Kissimmee
Life Clinical Trials
ACTIVE_NOT_RECRUITING
Margate
CZ Rheumatology
ACTIVE_NOT_RECRUITING
Miami Beach
Vitalia Medical Research
ACTIVE_NOT_RECRUITING
Palm Beach Gardens
International Center for Research
COMPLETED
Tampa
Georgia
Atlanta Research Center for Rheumatology
ACTIVE_NOT_RECRUITING
Marietta
Satilla Rheumatology & Internal Medicine
ACTIVE_NOT_RECRUITING
Waycross
Illinois
Great Lakes Clinical Trials - Ravenswood
ACTIVE_NOT_RECRUITING
Chicago
Greater Chicago Specialty Physicians
ACTIVE_NOT_RECRUITING
Schaumburg
Arnold Arthritis & Rheumatology
ACTIVE_NOT_RECRUITING
Skokie
Willow Rheumatology and Wellness PLLC
ACTIVE_NOT_RECRUITING
Willowbrook
Indiana
Lake Cumberland Rheumatology
ACTIVE_NOT_RECRUITING
New Albany
Louisiana
Accurate Clinical Research, Inc
COMPLETED
Lake Charles
Maryland
Klein & Associates, M.D., P.A.
ACTIVE_NOT_RECRUITING
Cumberland
Klein & Associates, M.D., P.A.
ACTIVE_NOT_RECRUITING
Hagerstown
Michigan
Clinical Research Institute of Michigan, LLC
ACTIVE_NOT_RECRUITING
Saint Clair Shores
Montana
Logan Health Rheumatology
ACTIVE_NOT_RECRUITING
Kalispell
North Carolina
Onsite Clinical Solutions, LLC - Brenner Ave
ACTIVE_NOT_RECRUITING
Salisbury
New York
University of Rochester Medical Center
ACTIVE_NOT_RECRUITING
Rochester
Ohio
Paramount Medical Research & Consulting, LLC
ACTIVE_NOT_RECRUITING
Middleburg Heights
Oklahoma
Essential Medical Research
ACTIVE_NOT_RECRUITING
Tulsa
Tennessee
West Tennessee Research Institute
ACTIVE_NOT_RECRUITING
Jackson
AARA Clinical Research - Murfreesboro Medical Clinic
ACTIVE_NOT_RECRUITING
Murfreesboro
Texas
Precision Comprehensive Clinical Research Solutions - Colleyville
RECRUITING
Colleyville
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
ACTIVE_NOT_RECRUITING
Fort Worth
Accurate Clinical Research, Inc
RECRUITING
Houston
Research Physicians Network, LLC
ACTIVE_NOT_RECRUITING
Houston
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
ACTIVE_NOT_RECRUITING
Irving
Biopharma Informatic, LLC
ACTIVE_NOT_RECRUITING
Katy
Advanced Rheumatology of Houston - Woodlands
ACTIVE_NOT_RECRUITING
The Woodlands
DM Clinical Research - TRA
RECRUITING
Tomball
Washington
Seattle Rheumatology Associates PLLC
ACTIVE_NOT_RECRUITING
Seattle
Arthritis Northwest, PLLC
ACTIVE_NOT_RECRUITING
Spokane Valley
Other Locations
Puerto Rico
Reuviva Research Center
COMPLETED
Guaynabo
CMRC Headlands, LLC
RECRUITING
San Juan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2027-11
Participants
Target number of participants: 200
Treatments
Experimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company