En studie för att undersöka effektiviteten av tirzepatid efter initiering av ixekizumab hos deltagare med aktiv psoriasisartrit och övervikt eller fetma i klinisk praxis
En fas 4, prospektiv, öppen etikett, enarmstudie för att bedöma effektiviteten av tirzepatid efter initiering av ixekizumab hos vuxna deltagare med aktiv psoriasisartrit och övervikt eller fetma i klinisk praxis.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Arizona
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Avondale, Arizona, Förenta staterna, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Förenta staterna, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Förenta staterna, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Förenta staterna, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Förenta staterna, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Förenta staterna, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Förenta staterna, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Förenta staterna, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Förenta staterna, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Förenta staterna, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Förenta staterna, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Förenta staterna, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Förenta staterna, 92648
- Newport Huntington Medical Group
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La Mesa, California, Förenta staterna, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Förenta staterna, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Förenta staterna, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Förenta staterna, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Förenta staterna, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Förenta staterna, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Förenta staterna, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Förenta staterna, 34741
- Vida Clinical Research
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Margate, Florida, Förenta staterna, 33063
- Life Clinical Trials
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Miami Beach, Florida, Förenta staterna, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Förenta staterna, 33410
- Vitalia Medical Research
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Tampa, Florida, Förenta staterna, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Förenta staterna, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Förenta staterna, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Förenta staterna, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Förenta staterna, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Förenta staterna, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Förenta staterna, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Förenta staterna, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Förenta staterna, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Förenta staterna, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Förenta staterna, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Förenta staterna, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Förenta staterna, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Förenta staterna, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Förenta staterna, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Förenta staterna, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Förenta staterna, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Förenta staterna, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Förenta staterna, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Förenta staterna, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Förenta staterna, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Förenta staterna, 77089
- Research Physicians Network, LLC
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Houston, Texas, Förenta staterna, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Förenta staterna, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Förenta staterna, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Förenta staterna, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Förenta staterna, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Förenta staterna, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Förenta staterna, 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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Tidsram: 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
Tidsram: 12 Months
|
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Tidsram: 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
Tidsram: 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%
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Percentage of Participants Achieving Physician Global Assessment of Disease Activity (PhGADA) NRS ≤2
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Month 6
|
Percentage of participants with ≥10% weight loss at month 6. |
Month 6
|
|
Mean Percent Change of Weight from Baseline
Tidsram: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: 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
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Skelettsjukdomar
- Muskuloskeletala sjukdomar
- Näringsstörningar
- Artrit
- Ledsjukdomar
- Övernäring
- Kroppsvikt
- Spinal sjukdomar
- Spondylarthropatier
- Hudsjukdomar, Papulosquamous
- Hudsjukdomar
- Spondylartrit
- Spondylit
- Psoriasis
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Hud- och bindvävssjukdomar
- Tecken och symtom
- Övervikt
- Fetma
- Artrit, psoriasis
- Aminosyror, peptider och proteiner
- Proteiner
- Glukagonliknande peptid-1-receptor
- Glukagonliknande peptidreceptorer
- Receptorer, G-proteinkopplad
- Receptorer, cellytan
- Membranproteiner
- Receptorer, gastrointestinalt hormon
- Receptorer, peptid
- Tirzepatid
Andra studie-ID-nummer
- 27350
- I1F-MC-RHDE (Annan identifierare: Eli Lilly and Company)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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