Une étude visant à étudier l'efficacité du tirzépatide après l'initiation de l'ixékizumab chez les participants souffrant d'arthrite psoriasique active et de surpoids ou d'obésité dans la pratique clinique
Une étude de phase 4, prospective, ouverte et à bras unique pour évaluer l'efficacité du tirzépatide après le début de l'ixékizumab chez les participants adultes souffrant d'arthrite psoriasique active et de surpoids ou d'obésité dans la pratique clinique.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Guaynabo, Porto Rico, 00968
- Reuviva Research Center
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San Juan, Porto Rico, 00918
- CMRC Headlands, LLC
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Arizona
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Avondale, Arizona, États-Unis, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, États-Unis, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, États-Unis, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, États-Unis, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, États-Unis, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, États-Unis, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, États-Unis, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, États-Unis, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, États-Unis, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, États-Unis, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, États-Unis, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, États-Unis, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, États-Unis, 92648
- Newport Huntington Medical Group
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La Mesa, California, États-Unis, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, États-Unis, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, États-Unis, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, États-Unis, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, États-Unis, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, États-Unis, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, États-Unis, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, États-Unis, 34741
- Vida Clinical Research
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Margate, Florida, États-Unis, 33063
- Life Clinical Trials
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Miami Beach, Florida, États-Unis, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, États-Unis, 33410
- Vitalia Medical Research
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Tampa, Florida, États-Unis, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, États-Unis, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, États-Unis, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, États-Unis, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, États-Unis, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, États-Unis, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, États-Unis, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, États-Unis, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, États-Unis, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, États-Unis, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, États-Unis, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, États-Unis, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, États-Unis, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, États-Unis, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, États-Unis, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, États-Unis, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, États-Unis, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, États-Unis, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, États-Unis, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, États-Unis, 77089
- Research Physicians Network, LLC
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Houston, Texas, États-Unis, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, États-Unis, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, États-Unis, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, États-Unis, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, États-Unis, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, États-Unis, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, États-Unis, 99216
- Arthritis Northwest, PLLC
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Délai: 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
Délai: 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%
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Month 6
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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
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Percentage of Participants with ≥10% Weight Loss at Month 6
Délai: 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
Délai: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: 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
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies osseuses
- Maladies musculo-squelettiques
- Troubles nutritionnels
- Arthrite
- Maladies articulaires
- Suralimentation
- Poids
- Maladies de la colonne vertébrale
- Spondylarthropathies
- Maladies de la peau, papulosquameuses
- Maladies de la peau
- Spondylarthrite
- Spondylarthrite
- Psoriasis
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Maladies de la peau et du tissu conjonctif
- Signes et symptômes
- En surpoids
- Obésité
- Arthrite, Psoriasique
- Acides aminés, peptides et protéines
- Protéines
- Récepteur du peptide-1 de type glucagon
- Récepteurs peptidiques de type glucagon
- Récepteurs, G-protéines G
- Récepteurs, surface cellulaire
- Protéines membranaires
- Récepteurs, hormones gastro-intestinales
- Récepteurs, peptide
- Tirzépatide
Autres numéros d'identification d'étude
- 27350
- I1F-MC-RHDE (Autre identifiant: Eli Lilly and Company)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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