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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHDE | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy | 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. | 12 Months |
| Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy | Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Tender Joint Count (TJC) ≤1 | Percentage of participants achieving TJC ≤1. | Month 6 and Month 12 |
| Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale | Recruiting | Avondale | Arizona | 85392 | United States |
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| Label | URL |
|---|---|
| Lilly Trials | View source |
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Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Percentage of participants achieving SJC ≤1.
| Month 6 and Month 12 |
| Percentage of Participants Achieving Body Surface Area (BSA) ≤3% | Percentage of participants achieving BSA ≤3%. | Month 6 and Month 12 |
| Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2 | 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. | Month 6 and Month 12 |
| Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15 | 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." | Month 6 and Month 12 |
| Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2 | The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease." | Month 6 and Month 12 |
| Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss | 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. | Month 6 and Month 12 |
| Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline | 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). | Month 6 and Month 12 |
| Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID) | 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. | Month 6 and Month 12 |
| Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID | 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. | Month 6 and Month 12 |
| Percentage of Participants Achieving a HAQ-DI score ≤0.5 | 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. | Month 6 |
| Percentage of Participants with ≥10% Weight Loss at Month 6 | Percentage of participants with ≥10% weight loss at month 6. | Month 6 |
| Mean Percent Change of Weight from Baseline | Mean percent change of weight from baseline. | Baseline, Month 6 and Baseline, Month 12 |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler | Recruiting | Chandler | Arizona | 85225 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff | Recruiting | Flagstaff | Arizona | 86001 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert | Recruiting | Gilbert | Arizona | 85297 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale | Recruiting | Glendale | Arizona | 85306 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa | Recruiting | Mesa | Arizona | 85210 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV | Recruiting | Phoenix | Arizona | 85032 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City | Recruiting | Sun City | Arizona | 85351 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson | Recruiting | Tucson | Arizona | 85704 | United States |
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| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast | Recruiting | Tucson | Arizona | 85748 | United States |
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| Medvin Clinical Research - Apple Valley | Recruiting | Apple Valley | California | 92307 | United States |
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| Medvin Clinical Research - Covina | Recruiting | Covina | California | 91722 | United States |
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| Newport Huntington Medical Group | Recruiting | Huntington Beach | California | 92648 | United States |
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| Purushotham & Akther Kotha MD, Inc | Recruiting | La Mesa | California | 91942 | United States |
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| Medvin Clinical Research - Riverside | Recruiting | Riverside | California | 92508 | United States |
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| Rheumatology Center of San Diego | Recruiting | San Diego | California | 92128 | United States |
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| Providence Saint John's Medical Foundation | Recruiting | Santa Monica | California | 90404 | United States |
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| Medvin Clinical Research - Temecula | Recruiting | Temecula | California | 92592 | United States |
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| Medvin Clinical Research - Tujunga | Recruiting | Tujunga | California | 91042 | United States |
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| Medvin Clinical Research - Whittier | Recruiting | Whittier | California | 90602 | United States |
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| Vida Clinical Research | Recruiting | Kissimmee | Florida | 34741 | United States |
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| Life Clinical Trials | Recruiting | Margate | Florida | 33063 | United States |
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| CZ Rheumatology | Recruiting | Miami Beach | Florida | 33140 | United States |
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| Vitalia Medical Research | Recruiting | Palm Beach Gardens | Florida | 33410 | United States |
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| International Center for Research | Recruiting | Tampa | Florida | 33614 | United States |
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| Atlanta Research Center for Rheumatology | Recruiting | Marietta | Georgia | 30060 | United States |
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| Satilla Rheumatology & Internal Medicine | Recruiting | Waycross | Georgia | 31501 | United States |
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| Great Lakes Clinical Trials - Ravenswood | Recruiting | Chicago | Illinois | 60640 | United States |
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| Greater Chicago Specialty Physicians | Recruiting | Schaumburg | Illinois | 60195 | United States |
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| Arnold Arthritis & Rheumatology | Recruiting | Skokie | Illinois | 60076 | United States |
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| Willow Rheumatology and Wellness PLLC | Recruiting | Willowbrook | Illinois | 60527 | United States |
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| Lake Cumberland Rheumatology | Recruiting | New Albany | Indiana | 47150 | United States |
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| Accurate Clinical Research, Inc | Recruiting | Lake Charles | Louisiana | 70605 | United States |
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| Klein & Associates, M.D., P.A. | Recruiting | Cumberland | Maryland | 21502 | United States |
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| Klein & Associates, M.D., P.A. | Recruiting | Hagerstown | Maryland | 21740 | United States |
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| Clinical Research Institute of Michigan, LLC | Recruiting | Saint Clair Shores | Michigan | 48081 | United States |
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| Logan Health Rheumatology | Recruiting | Kalispell | Montana | 59901 | United States |
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| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
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| Onsite Clinical Solutions, LLC - Brenner Ave | Recruiting | Salisbury | North Carolina | 28144 | United States |
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| Paramount Medical Research & Consulting, LLC | Recruiting | Middleburg Heights | Ohio | 44130 | United States |
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| Essential Medical Research | Recruiting | Tulsa | Oklahoma | 74137 | United States |
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| West Tennessee Research Institute | Recruiting | Jackson | Tennessee | 38305 | United States |
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| AARA Clinical Research - Murfreesboro Medical Clinic | Recruiting | Murfreesboro | Tennessee | 37128 | United States |
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| Precision Comprehensive Clinical Research Solutions - Colleyville | Recruiting | Colleyville | Texas | 76034 | United States |
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| AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth | Recruiting | Fort Worth | Texas | 76109 | United States |
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| Accurate Clinical Research, Inc | Recruiting | Houston | Texas | 77089 | United States |
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| Research Physicians Network, LLC | Recruiting | Houston | Texas | 77089 | United States |
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| AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving | Recruiting | Irving | Texas | 75039 | United States |
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| Biopharma Informatic, LLC | Recruiting | Katy | Texas | 77494 | United States |
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| Advanced Rheumatology of Houston - Woodlands | Recruiting | The Woodlands | Texas | 77382 | United States |
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| DM Clinical Research - TRA | Recruiting | Tomball | Texas | 77375 | United States |
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| Seattle Rheumatology Associates PLLC | Recruiting | Seattle | Washington | 98104 | United States |
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| Arthritis Northwest, PLLC | Recruiting | Spokane Valley | Washington | 99216 | United States |
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| Reuviva Research Center | Recruiting | Guaynabo | 00968 | Puerto Rico |
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| CMRC Headlands, LLC | Recruiting | San Juan | 00918 | Puerto Rico |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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