Een onderzoek om de effectiviteit van tirzepatide te onderzoeken na het initiëren van ixekizumab bij deelnemers met actieve psoriatica -artritis en overgewicht of obesitas in de klinische praktijk
Een fase 4, prospectieve, open-label, single-arm studie om de effectiviteit van tirzepatide te beoordelen na het initiëren van ixekizumab bij volwassen deelnemers met actieve psoriatica-artritis en overgewicht of obesitas in de klinische praktijk.
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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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, Verenigde Staten, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Verenigde Staten, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Verenigde Staten, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Verenigde Staten, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Verenigde Staten, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Verenigde Staten, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Verenigde Staten, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Verenigde Staten, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Verenigde Staten, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Verenigde Staten, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Verenigde Staten, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Verenigde Staten, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Verenigde Staten, 92648
- Newport Huntington Medical Group
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La Mesa, California, Verenigde Staten, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Verenigde Staten, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Verenigde Staten, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Verenigde Staten, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Verenigde Staten, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Verenigde Staten, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Verenigde Staten, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Verenigde Staten, 34741
- Vida Clinical Research
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Margate, Florida, Verenigde Staten, 33063
- Life Clinical Trials
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Miami Beach, Florida, Verenigde Staten, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Verenigde Staten, 33410
- Vitalia Medical Research
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Tampa, Florida, Verenigde Staten, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Verenigde Staten, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Verenigde Staten, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Verenigde Staten, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Verenigde Staten, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Verenigde Staten, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Verenigde Staten, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Verenigde Staten, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Verenigde Staten, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Verenigde Staten, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Verenigde Staten, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Verenigde Staten, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Verenigde Staten, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Verenigde Staten, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Verenigde Staten, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Verenigde Staten, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Verenigde Staten, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Verenigde Staten, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Verenigde Staten, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Verenigde Staten, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Verenigde Staten, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Verenigde Staten, 77089
- Research Physicians Network, LLC
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Houston, Texas, Verenigde Staten, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Verenigde Staten, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Verenigde Staten, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Verenigde Staten, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Verenigde Staten, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Verenigde Staten, 99216
- Arthritis Northwest, PLLC
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Tijdsspanne: 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
Tijdsspanne: 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%
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Percentage of Participants With a Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue With ≥4-point Increase from Baseline
Tijdsspanne: 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)
Tijdsspanne: 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
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Percentage of Participants With a Short-Form 36 (SF36) Mental Component Score (MCS) MCID
Tijdsspanne: 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
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Percentage of Participants Achieving a HAQ-DI score ≤0.5
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: 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
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Botziekten
- Musculoskeletale aandoeningen
- Voedingsstoornissen
- Artritis
- Gewrichtsziekten
- Overvoeding
- Lichaamsgewicht
- Spinale ziekten
- Spondylarthropathieën
- Huidziekten, papulosquameus
- Huidziektes
- Spondylartritis
- Spondylitis
- Psoriasis
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Huid- en bindweefselaandoeningen
- Tekenen en symptomen
- Overgewicht
- Obesitas
- Artritis, psoriatica
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Glucagon-achtige peptide-1-receptor
- Glucagon-achtige peptideceptoren
- Receptoren, G-eiwit gekoppeld
- Receptoren, celoppervlak
- Membraaneiwitten
- Receptoren, gastro -intestinaal hormoon
- Receptoren, peptide
- Tirzepatide
Andere studie-ID-nummers
- 27350
- I1F-MC-RHDE (Andere identificatie: Eli Lilly and Company)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
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-toegangscriteria voor delen
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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