Tutkimus tirzepatidin tehokkuuden tutkimiseksi ixekizumabin aloittamisen jälkeen osallistujilla, joilla on aktiivinen psoriaattinen niveltulehdus ja ylipaino tai liikalihavuus kliinisessä käytännössä
Vaiheen 4, mahdollinen, avoin, yhden käsivarren tutkimus tirzepatidin tehokkuuden arvioimiseksi ixekizumabin aloittamisen jälkeen aikuisilla osallistujilla, joilla on aktiivinen psoriaattinen niveltulehdus ja ylipaino tai liikalihavuus kliinisessä käytännössä.
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Opiskelupaikat
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Guaynabo, Puerto Rico, 00968
- Reuviva Research Center
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San Juan, Puerto Rico, 00918
- CMRC Headlands, LLC
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Arizona
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Avondale, Arizona, Yhdysvallat, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Yhdysvallat, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Yhdysvallat, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Yhdysvallat, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Yhdysvallat, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Yhdysvallat, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Yhdysvallat, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Yhdysvallat, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Yhdysvallat, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Yhdysvallat, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Yhdysvallat, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Yhdysvallat, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Yhdysvallat, 92648
- Newport Huntington Medical Group
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La Mesa, California, Yhdysvallat, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Yhdysvallat, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Yhdysvallat, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Yhdysvallat, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Yhdysvallat, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Yhdysvallat, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Yhdysvallat, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Yhdysvallat, 34741
- Vida Clinical Research
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Margate, Florida, Yhdysvallat, 33063
- Life Clinical Trials
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Miami Beach, Florida, Yhdysvallat, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Yhdysvallat, 33410
- Vitalia Medical Research
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Tampa, Florida, Yhdysvallat, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Yhdysvallat, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Yhdysvallat, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Yhdysvallat, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Yhdysvallat, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Yhdysvallat, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Yhdysvallat, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Yhdysvallat, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Yhdysvallat, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Yhdysvallat, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Yhdysvallat, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Yhdysvallat, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Yhdysvallat, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Yhdysvallat, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Yhdysvallat, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Yhdysvallat, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Yhdysvallat, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Yhdysvallat, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Yhdysvallat, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Yhdysvallat, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Yhdysvallat, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Yhdysvallat, 77089
- Research Physicians Network, LLC
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Houston, Texas, Yhdysvallat, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Yhdysvallat, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Yhdysvallat, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Yhdysvallat, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Yhdysvallat, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Yhdysvallat, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Yhdysvallat, 99216
- Arthritis Northwest, PLLC
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Aikaikkuna: 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. |
12 Months
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Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Aikaikkuna: 12 Months
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Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Aikaikkuna: Month 6 and Month 12
|
Percentage of participants achieving TJC ≤1. |
Month 6 and Month 12
|
|
Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Aikaikkuna: Month 6 and Month 12
|
Percentage of participants achieving SJC ≤1. |
Month 6 and Month 12
|
|
Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Aikaikkuna: Month 6 and Month 12
|
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
Aikaikkuna: 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. |
Month 6 and Month 12
|
|
Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Aikaikkuna: 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." |
Month 6 and Month 12
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Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Aikaikkuna: Month 6 and Month 12
|
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
Aikaikkuna: 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. |
Month 6 and Month 12
|
|
Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Aikaikkuna: 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). |
Month 6 and Month 12
|
|
Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Aikaikkuna: 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. |
Month 6 and Month 12
|
|
Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Aikaikkuna: 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. |
Month 6 and Month 12
|
|
Percentage of Participants Achieving a HAQ-DI score ≤0.5
Aikaikkuna: 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
|
|
Percentage of Participants with ≥10% Weight Loss at Month 6
Aikaikkuna: Month 6
|
Percentage of participants with ≥10% weight loss at month 6. |
Month 6
|
|
Mean Percent Change of Weight from Baseline
Aikaikkuna: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: 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
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Luun sairaudet
- Tuki- ja liikuntaelinten sairaudet
- Ravitsemushäiriöt
- Niveltulehdus
- Nivelsairaudet
- Yliravitsemus
- Kehon paino
- Selkärangan sairaudet
- Spondylartropatiat
- Ihosairaudet, papulosquamous
- Ihosairaudet
- Spondylartriitti
- Spondyliitti
- Psoriasis
- Patologiset tilat, merkit ja oireet
- Ravitsemukselliset ja aineenvaihduntataudit
- Iho- ja sidekudostaudit
- Merkit ja oireet
- Ylipainoinen
- Lihavuus
- Niveltulehdus, psoriaattinen
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Glukagonin kaltainen peptidi-1-reseptori
- Glukagonin kaltaiset peptidireseptorit
- Reseptorit, G-proteiiniin kytketty
- Reseptorit, solun pinta
- Kalvoproteiinit
- Reseptorit, maha -suolikanavan hormoni
- Reseptorit, peptidi
- Tirzepatide
Muut tutkimustunnusnumerot
- 27350
- I1F-MC-RHDE (Muu tunniste: Eli Lilly and Company)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
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