Studie pro zkoumání účinnosti tirzepatidu po zahájení ixekizumabu u účastníků s aktivní psoriatickou artritidou a nadváhou nebo obezitou v klinické praxi
Studie fáze 4, prospektivní, otevřená značka, jednoramenná studie k posouzení účinnosti tirzepatidu po zahájení Ixekizumabu u dospělých účastníků s aktivní psoriatickou artritidou a nadváhou nebo obezitou v klinické praxi.
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Guaynabo, Portoriko, 00968
- Reuviva Research Center
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San Juan, Portoriko, 00918
- CMRC Headlands, LLC
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Arizona
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Avondale, Arizona, Spojené státy, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Spojené státy, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Spojené státy, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Spojené státy, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Spojené státy, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Spojené státy, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Spojené státy, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Spojené státy, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Spojené státy, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Spojené státy, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Spojené státy, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Spojené státy, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Spojené státy, 92648
- Newport Huntington Medical Group
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La Mesa, California, Spojené státy, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Spojené státy, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Spojené státy, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Spojené státy, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Spojené státy, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Spojené státy, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Spojené státy, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Spojené státy, 34741
- Vida Clinical Research
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Margate, Florida, Spojené státy, 33063
- Life Clinical Trials
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Miami Beach, Florida, Spojené státy, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Spojené státy, 33410
- Vitalia Medical Research
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Tampa, Florida, Spojené státy, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Spojené státy, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Spojené státy, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Spojené státy, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Spojené státy, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Spojené státy, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Spojené státy, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Spojené státy, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Spojené státy, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Spojené státy, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Spojené státy, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Spojené státy, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Spojené státy, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Spojené státy, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Spojené státy, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Spojené státy, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Spojené státy, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Spojené státy, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Spojené státy, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Spojené státy, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Spojené státy, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Spojené státy, 77089
- Research Physicians Network, LLC
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Houston, Texas, Spojené státy, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Spojené státy, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Spojené státy, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Spojené státy, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Spojené státy, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Spojené státy, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Spojené státy, 99216
- Arthritis Northwest, PLLC
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Časové okno: 12 Months
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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
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Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Časové okno: 12 Months
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Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Časové okno: Month 6 and Month 12
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Percentage of participants achieving TJC ≤1. |
Month 6 and Month 12
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Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Časové okno: Month 6 and Month 12
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Percentage of participants achieving SJC ≤1. |
Month 6 and Month 12
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Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Časové okno: Month 6 and Month 12
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Percentage of participants achieving BSA ≤3%. |
Month 6 and Month 12
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Percentage of Participants Achieving Patient Global Assessment of Disease Activity Numeric Rating Score (PaGADA NRS) of ≤2
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Časové okno: Month 6 and Month 12
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The PhGADA NRS is an 11-point scale anchored by 2 verbal descriptors, "none" and "extremely active disease." |
Month 6 and Month 12
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Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Časové okno: Month 6 and Month 12
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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
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Percentage of Participants Achieving a HAQ-DI score ≤0.5
Časové okno: 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. |
Month 6
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Percentage of Participants with ≥10% Weight Loss at Month 6
Časové okno: Month 6
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Percentage of participants with ≥10% weight loss at month 6. |
Month 6
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Mean Percent Change of Weight from Baseline
Časové okno: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: 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
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci kostí
- Nemoci pohybového aparátu
- Poruchy výživy
- Artritida
- Onemocnění kloubů
- Nadměrná výživa
- Tělesná hmotnost
- Nemoci páteře
- Spondylartropatie
- Kožní onemocnění, papuloskvamózní
- Kožní choroby
- Spondylartritida
- Spondylitida
- Psoriáza
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Onemocnění kůže a pojivové tkáně
- Příznaky a symptomy
- Nadváha
- Obezita
- Artritida, psoriatika
- Aminokyseliny, peptidy a proteiny
- Proteiny
- Glukagonský peptid-1 receptor
- Glukagonové peptidové receptory
- Receptory, G-protein-spojené
- Receptory, buněčný povrch
- Membránové proteiny
- Receptory, gastrointestinální hormon
- Receptory, peptid
- Tirzepatid
Další identifikační čísla studie
- 27350
- I1F-MC-RHDE (Jiný identifikátor: Eli Lilly and Company)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
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.
Kritéria přístupu pro sdílení IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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