Un estudio para investigar la efectividad del tirzepatido después del inicio de ixekizumab en participantes con artritis psoriásica activa y sobrepeso u obesidad en la práctica clínica
Un estudio de fase 4, prospectivo, abierto, de un solo brazo, para evaluar la efectividad del tirzepatido después del inicio de ixekizumab en participantes adultos con artritis psoriásica activa y sobrepeso u obesidad en la práctica clínica.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Avondale, Arizona, Estados Unidos, 85392
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
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Chandler, Arizona, Estados Unidos, 85225
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
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Flagstaff, Arizona, Estados Unidos, 86001
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
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Gilbert, Arizona, Estados Unidos, 85297
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
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Glendale, Arizona, Estados Unidos, 85306
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
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Mesa, Arizona, Estados Unidos, 85210
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
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Phoenix, Arizona, Estados Unidos, 85032
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
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Sun City, Arizona, Estados Unidos, 85351
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
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Tucson, Arizona, Estados Unidos, 85748
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
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Tucson, Arizona, Estados Unidos, 85704
- AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
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California
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Apple Valley, California, Estados Unidos, 92307
- Medvin Clinical Research - Apple Valley
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Covina, California, Estados Unidos, 91722
- Medvin Clinical Research - Covina
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Huntington Beach, California, Estados Unidos, 92648
- Newport Huntington Medical Group
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La Mesa, California, Estados Unidos, 91942
- Purushotham & Akther Kotha MD, Inc
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Riverside, California, Estados Unidos, 92508
- Medvin Clinical Research - Riverside
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San Diego, California, Estados Unidos, 92128
- Rheumatology Center of San Diego
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Santa Monica, California, Estados Unidos, 90404
- Providence Saint John's Medical Foundation
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Temecula, California, Estados Unidos, 92592
- Medvin Clinical Research - Temecula
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Tujunga, California, Estados Unidos, 91042
- Medvin Clinical Research - Tujunga
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Whittier, California, Estados Unidos, 90602
- Medvin Clinical Research - Whittier
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Florida
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Kissimmee, Florida, Estados Unidos, 34741
- Vida Clinical Research
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Margate, Florida, Estados Unidos, 33063
- Life Clinical Trials
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Miami Beach, Florida, Estados Unidos, 33140
- CZ Rheumatology
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Palm Beach Gardens, Florida, Estados Unidos, 33410
- Vitalia Medical Research
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Tampa, Florida, Estados Unidos, 33614
- International Center for Research
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Atlanta Research Center for Rheumatology
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Waycross, Georgia, Estados Unidos, 31501
- Satilla Rheumatology & Internal Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60640
- Great Lakes Clinical Trials - Ravenswood
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Schaumburg, Illinois, Estados Unidos, 60195
- Greater Chicago Specialty Physicians
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Skokie, Illinois, Estados Unidos, 60076
- Arnold Arthritis & Rheumatology
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Willowbrook, Illinois, Estados Unidos, 60527
- Willow Rheumatology and Wellness PLLC
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Indiana
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New Albany, Indiana, Estados Unidos, 47150
- Lake Cumberland Rheumatology
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Louisiana
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Lake Charles, Louisiana, Estados Unidos, 70605
- Accurate Clinical Research, Inc
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Maryland
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Cumberland, Maryland, Estados Unidos, 21502
- Klein & Associates, M.D., P.A.
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Hagerstown, Maryland, Estados Unidos, 21740
- Klein & Associates, M.D., P.A.
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Michigan
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Saint Clair Shores, Michigan, Estados Unidos, 48081
- Clinical Research Institute of Michigan, LLC
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Montana
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Kalispell, Montana, Estados Unidos, 59901
- Logan Health Rheumatology
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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North Carolina
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Salisbury, North Carolina, Estados Unidos, 28144
- Onsite Clinical Solutions, LLC - Brenner Ave
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Ohio
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Middleburg Heights, Ohio, Estados Unidos, 44130
- Paramount Medical Research & Consulting, LLC
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos, 74137
- Essential Medical Research
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
- West Tennessee Research Institute
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Murfreesboro, Tennessee, Estados Unidos, 37128
- AARA Clinical Research - Murfreesboro Medical Clinic
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Texas
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Colleyville, Texas, Estados Unidos, 76034
- Precision Comprehensive Clinical Research Solutions - Colleyville
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Fort Worth, Texas, Estados Unidos, 76109
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
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Houston, Texas, Estados Unidos, 77089
- Research Physicians Network, LLC
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Houston, Texas, Estados Unidos, 77089
- Accurate Clinical Research, Inc
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Irving, Texas, Estados Unidos, 75039
- AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
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Katy, Texas, Estados Unidos, 77494
- Biopharma Informatic, LLC
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The Woodlands, Texas, Estados Unidos, 77382
- Advanced Rheumatology of Houston - Woodlands
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Tomball, Texas, Estados Unidos, 77375
- DM Clinical Research - TRA
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Seattle Rheumatology Associates PLLC
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Spokane Valley, Washington, Estados Unidos, 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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Periodo de tiempo: 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
Periodo de tiempo: 12 Months
|
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Periodo de tiempo: 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
Periodo de tiempo: 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%
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Percentage of Participants Achieving Patient Pain Visual Analogue Scale (VAS) ≤15
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Month 6
|
Percentage of participants with ≥10% weight loss at month 6. |
Month 6
|
|
Mean Percent Change of Weight from Baseline
Periodo de tiempo: Baseline, Month 6 and Baseline, Month 12
|
Mean percent change of weight from baseline. |
Baseline, Month 6 and Baseline, Month 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: 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
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Trastornos Nutricionales
- Artritis
- Enfermedades Articulares
- Sobrenutrición
- Peso corporal
- Enfermedades de la columna
- Espondiloartropatías
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Espondiloartritis
- Espondilitis
- Soriasis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Exceso de peso
- Obesidad
- Artritis, Psoriásica
- Aminoácidos, péptidos y proteínas
- Proteínas
- Receptor de péptido-1 tipo glucagón
- Receptores de péptidos tipo glucagón
- Receptores, acoplados a la proteína G
- Receptores, superficie celular
- Proteínas de membrana
- Receptores, hormona gastrointestinal
- Receptores, péptido
- Tirzepatide
Otros números de identificación del estudio
- 27350
- I1F-MC-RHDE (Otro identificador: Eli Lilly and Company)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .