Um estudo para investigar a eficácia do Tirzepatide após o início do ixekizumab em participantes com artrite psoriática ativa e sobrepeso ou obesidade na prática clínica
Um estudo de fase 4, prospectivo, aberto e de braço único para avaliar a eficácia do Tirzepatida após o início do ixekizumab em participantes adultos com artrite psoriática ativa e sobrepeso ou obesidade na prática 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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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, Porto Rico, 00968
- Reuviva Research Center
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San Juan, Porto Rico, 00918
- CMRC Headlands, LLC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tirzepatide
Participants will continue on ixekizumab and take tirzepatide administered subcutaneously (SC) as per label. |
Administered SC
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy
Prazo: 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
Prazo: 12 Months
|
Percentage of participants achieving at least a 10% weight loss at 12 months of therapy. |
12 Months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving Tender Joint Count (TJC) ≤1
Prazo: Month 6 and Month 12
|
Percentage of participants achieving TJC ≤1. |
Month 6 and Month 12
|
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Percentage of Participants Achieving Swollen Joint Count (SJC) ≤1
Prazo: Month 6 and Month 12
|
Percentage of participants achieving SJC ≤1. |
Month 6 and Month 12
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Percentage of Participants Achieving Body Surface Area (BSA) ≤3%
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
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Percentage of Participants Achieving HAQ-DI Sore ≤0.5 and at Least a 10% Weight Loss
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: 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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças ósseas
- Doenças musculoesqueléticas
- Distúrbios Nutricionais
- Artrite
- Doenças articulares
- Supernutrição
- Peso corporal
- Doenças da coluna vertebral
- Espondilartropatias
- Doenças de Pele Papuloescamosas
- Doenças de pele
- Espondilartrite
- Espondilite
- Psoríase
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Doenças da Pele e do Tecido Conjuntivo
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Artrite, Psoriática
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Receptor peptídeo 1 do tipo glucagon
- Receptores peptídicos semelhantes a glucagon
- Receptores, acoplado à proteína G.
- Receptores, superfície celular
- Proteínas da membrana
- Receptores, hormônio gastrointestinal
- Receptores, peptídeo
- Tirzepatide
Outros números de identificação do estudo
- 27350
- I1F-MC-RHDE (Outro identificador: Eli Lilly and Company)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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