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)
- Registration Number
- NCT06864026
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy 12 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 Therapy 12 Months Percentage of participants achieving at least a 10% weight loss at 12 months of therapy.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Tender Joint Count (TJC) ≤1 Month 6 and Month 12 Percentage of participants achieving TJC ≤1.
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1 Month 6 and Month 12 Percentage of participants achieving SJC ≤1.
Percentage of Participants Achieving Body Surface Area (BSA) ≤3% Month 6 and Month 12 Percentage of participants achieving BSA ≤3%.
Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2 Month 6 and Month 12 The PaGADA NRS is an 11-point scale from 0 to 10 that is anchored by 2 verbal descriptors, "very well" and "very poor." Higher scores represent a higher level of disease activity.
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15 Month 6 and Month 12 The Patient's Assessment of Arthritis Pain is a single-item, patient-reported outcome instrument, used to access the current severity of participants' joint pain in relation to their PsA on a horizontal VAS of 0 to 100 mm. The Patient's Assessment of Arthritis Pain is anchored by 2 verbal descriptors, "no pain" and "as severe as can imagine."
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2 Month 6 and Month 12 The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease."
Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss Month 6 and Month 12 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 With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline Month 6 and Month 12 FACIT-F is a patient-reported, 13-item questionnaire that specifically assess the self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses 0 ("not at all") to 4 ("very much") Likert scale to assess fatigue and its impact in the past 7 days. Total score ranges from 0 to 52, based on a rating of 5-point Likert scale. Scores for negatively worded items are reversed, such that higher scores are better (that is, less fatigue).
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID) Month 6 and Month 12 The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID Month 6 and Month 12 The SF-36v2 acute form is a 36-item, generic, patient-completed measure designed to assess health-related quality of life with 8 health domains. Items are rated on 3-, 5-, or 6-point Likert scales. Each domain is individually scored by summing item responses and transforming them to a 0-100 scale. The eight domains are aggregated into two summary scores: Physical and Mental Component Summaries. Each summary score is norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10, with higher scores indicating better health status or functioning.
Percentage of Participants Achieving a HAQ-DI score ≤0.5 Month 6 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 with ≥10% Weight Loss at Month 6 Month 6 Percentage of participants with ≥10% weight loss at month 6.
Mean Percent Change of Weight from Baseline Baseline, Month 6 and Baseline, Month 12 Mean percent change of weight from baseline.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (54)
Vida Clinical Research
🇺🇸Kissimmee, Florida, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Saint Clair Shores, Michigan, United 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
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
Conquest Research
🇺🇸Winter Park, Florida, United States
Atlanta Research Center for Rheumatology
🇺🇸Marietta, 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
🇺🇸Houston, Texas, United States
Klein & Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, 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
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
SouthWest Rheumatology Research, LLC
🇺🇸Mesquite, 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, Washington, United States
Reuviva Research Center
🇵🇷Guaynabo, Puerto Rico
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico