En studie for å undersøke effektiviteten av tirzepatid etter igangsetting av ixekizumab hos deltakere med aktiv psoriasisartritt og overvekt eller overvekt i klinisk praksis
En fase 4, prospektiv, åpen, en-armer-studie for å vurdere effektiviteten av tirzepatid etter initiering av ixekizumab hos voksne deltakere med aktiv psoriasisartritt og overvekt eller overvekt i klinisk praksis.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Arizona
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Avondale, Arizona, Forente stater, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Forente stater, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Forente stater, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Forente stater, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Forente stater, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Forente stater, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Forente stater, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Forente stater, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Forente stater, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Forente stater, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Forente stater, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Forente stater, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Forente stater, 92648
- Newport Huntington Medical Group
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La Mesa, California, Forente stater, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Forente stater, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Forente stater, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Forente stater, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Forente stater, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Forente stater, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Forente stater, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Forente stater, 34741
- Vida Clinical Research
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Margate, Florida, Forente stater, 33063
- Life Clinical Trials
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Miami Beach, Florida, Forente stater, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Forente stater, 33410
- Vitalia Medical Research
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Tampa, Florida, Forente stater, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Forente stater, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Forente stater, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Forente stater, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Forente stater, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Forente stater, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Forente stater, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Forente stater, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Forente stater, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Forente stater, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Forente stater, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Forente stater, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Forente stater, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Forente stater, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Forente stater, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Forente stater, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Forente stater, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Forente stater, 77089
- Research Physicians Network, LLC
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Houston, Texas, Forente stater, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Forente stater, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Forente stater, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Forente stater, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Forente stater, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Forente stater, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Forente stater, 99216
- Arthritis Northwest, PLLC
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Tidsramme: 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
|
|
Percentage of Participants Achieving at Least a 10% Weight Loss at 12 Months of Therapy
Tidsramme: 12 Months
|
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Tidsramme: 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
Tidsramme: 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%
Tidsramme: Month 6 and Month 12
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Percentage of Participants With a Short-Form 36 (SF36) Physical Component Score (PCS) Minimum Clinically Important Difference (MCID)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Month 6
|
Percentage of participants with ≥10% weight loss at month 6. |
Month 6
|
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Mean Percent Change of Weight from Baseline
Tidsramme: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: 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
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Beinsykdommer
- Muskel- og skjelettsykdommer
- Ernæringsforstyrrelser
- Leddgikt
- Leddsykdommer
- Overernæring
- Kroppsvekt
- Spinal sykdommer
- Spondylarthropatier
- Hudsykdommer, Papulosquamous
- Hudsykdommer
- Spondylartritt
- Spondylitt
- Psoriasis
- Patologiske tilstander, tegn og symptomer
- Ernæringsmessige og metabolske sykdommer
- Hud- og bindevevssykdommer
- Tegn og symptomer
- Overvektig
- Overvekt
- Leddgikt, psoriasis
- Aminosyrer, peptider og proteiner
- Proteiner
- Glukagonlignende peptid-1 reseptor
- Glukagonlignende peptidreseptorer
- Reseptorer, G-protein-koblet
- Reseptorer, celleoverflate
- Membranproteiner
- Reseptorer, gastrointestinal hormon
- Reseptorer, peptid
- Tirzepatid
Andre studie-ID-numre
- 27350
- I1F-MC-RHDE (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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.
Tilgangskriterier for IPD-deling
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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