INSIGHT-IBD Pragmatic Study
INSIGHT-IBD Pragmatic Study: Investigation of Mirikizumab in Real World Settings for Mirikizumab
The goal of this study is to evaluate the real-world effectiveness of treatments for inflammatory bowel disease (IBD) within routine clinical practice.
The study population includes adult patients (≥21 years) with ulcerative colitis (UC) or Crohn's disease (CD) receiving care in community gastroenterology practices in the United States.
The main questions it aims to answer are:
- Does treatment with mirikizumab reduce the proportion of patients requiring an increase in IBD disease management (e.g., unplanned visits, dose escalation, therapy switch, emergency department visits, or hospitalization)?
- Does treatment with mirikizumab improve clinical outcomes, including disease activity, clinical remission, and patient-reported outcomes, compared to standard biologic therapy?
- Researchers will compare patients treated with mirikizumab within the IBD Clinical Care Pathway versus patients receiving standard biologic therapies to see if mirikizumab leads to improved disease control and reduced healthcare utilization.
Participants will:
- Receive either mirikizumab or standard biologic therapy as part of routine clinical care
- Attend follow-up visits at approximately 3, 6, 12, and 18 months
- Have clinical data collected from electronic health records and healthcare utilization sources
- Complete patient-reported outcome questionnaires assessing symptoms, quality of life, and daily functioning
- Undergo routine laboratory tests and clinical assessments as part of standard care
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Lorraine O'Donnell
- Número de telefone: 914-388-4907
- E-mail: lorraine.odonnell@cardinalhealth.com
Estude backup de contato
- Nome: Jessica Manzyuk
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ≥21 years at the time of enrollment
- Confirmed diagnosis of ulcerative colitis (UC) or Crohn's disease (CD)
- Eligible for treatment with biologic therapy for IBD, defined as failure of prior conventional therapy and/or prior biologic therapy (excluding IL-23p19 antagonists)
- No prior exposure to mirikizumab and no contraindications to mirikizumab
- Ability to provide informed consent
- Willingness to comply with study procedures and follow-up requirements
Exclusion Criteria:
- Prior exposure to IL-23p19 antagonists (e.g., mirikizumab, risankizumab, guselkumab)
- Prior exposure to small molecule targeted therapies for IBD (e.g., JAK inhibitors or S1P receptor modulators)
- Participation in an interventional clinical trial within 90 days prior to enrollment
- History of extensive colorectal resection, including:
- Total proctocolectomy (for UC), or
- Surgical removal of two or more intestinal segments (for CD)
- Any condition that, in the investigator's judgment, may compromise patient safety, data integrity, or ability to participate in the study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Mirikizumab Clinical Care Pathway
Participants receive mirikizumab as part of the IBD Clinical Care Pathway in routine clinical practice.
Dosing and administration follow the approved prescribing information for ulcerative colitis or Crohn's disease, with treatment and monitoring per standard of care.
|
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
|
|
Comparador Ativo: Standard Biologic Therapy Clinical Care Pathway
Participants receive standard biologic therapies for IBD as part of the IBD Clinical Care Pathway according to physician discretion and routine clinical practice.
Therapies may include anti-TNF agents, anti-integrins, IL-12/23 antagonists, or IL-23p19 antagonists.
|
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of Patients Requiring an Increase in IBD Disease Management
Prazo: Up to 18 months following initiation of therapy
|
The proportion of patients requiring an increase in inflammatory bowel disease (IBD) disease management, defined as a composite of treatment and healthcare resource use, while receiving index therapy.
|
Up to 18 months following initiation of therapy
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in disease activity assessed using validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (CD PRO2), composed of: Abdominal pain score (range 0-3) Stool frequency (number of bowel movements per day; higher values indicate worse disease activity) Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity. |
Baseline, 6 months, 12 months, and 18 months
|
|
Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in disease activity assessed using validated patient-reported outcome measures: Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Total possible combined score range: 0-6, with higher scores indicating worse disease activity Changes in PRO2 component scores and composite disease activity will be evaluated over time, with decreases from baseline indicating improvement in disease activity. |
Baseline, 6 months, 12 months, and 18 months
|
|
Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD)
Prazo: Up to 18 months (as available from routine clinical care)
|
Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring system: Simple Endoscopic Score for Crohn's Disease (SES-CD) (range 0-56), where lower scores indicate less endoscopic disease activity and endoscopic remission is defined as a score ≤2 Endoscopic findings are collected as part of routine clinical care, when available. |
Up to 18 months (as available from routine clinical care)
|
|
Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score.
Prazo: Up to 18 months (as available from routine clinical care)
|
Proportion of participants achieving endoscopic remission assessed using validated endoscopic scoring systems: Modified Baron Score (ulcerative colitis) (range 0-4), where lower scores indicate less mucosal inflammation and endoscopic remission is defined as a score of 0 (normal mucosa with no visible inflammation) Endoscopic findings are collected as part of routine clinical care, when available. |
Up to 18 months (as available from routine clinical care)
|
|
Treatment Persistence
Prazo: Up to 18 months
|
Duration of time from treatment initiation to discontinuation of index therapy for any reason, including continued use at pre-specified timepoints.
|
Up to 18 months
|
|
Proportion of Patients with Dose Escalation
Prazo: Up to 18 months
|
Proportion of patients who discontinue index therapy and/or initiate a subsequent IBD therapy during the study period.
|
Up to 18 months
|
|
Time to Next Treatment
Prazo: Up to 18 months
|
Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy.
|
Up to 18 months
|
|
Concomitant Medication Use
Prazo: Baseline through 18 months
|
Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns.
|
Baseline through 18 months
|
|
Corticosteroid-Free Time
Prazo: Up to 18 months
|
Duration of time patients remain free from corticosteroid use while receiving index therapy.
|
Up to 18 months
|
|
Healthcare Resource Utilization
Prazo: Up to 18 months
|
Frequency and rate of IBD-related healthcare utilization
|
Up to 18 months
|
|
Change in Patient-Reported Outcomes Measured by SIBDQ
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in patient-reported outcomes assessed using validated instrument: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (range 10-70), where higher scores indicate better health-related quality of life Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes. |
Baseline, 6 months, 12 months, and 18 months
|
|
Change in Patient-Reported Outcomes Measured by UNRS
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in patient-reported outcomes assessed using validated instrument: Bowel Urgency Numeric Rating Scale (UNRS) (range 0-10), where higher scores indicate worse bowel urgency Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes. |
Baseline, 6 months, 12 months, and 18 months
|
|
Change in Patient-Reported Outcomes Measured by PROMIS Global Health
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in patient-reported outcomes assessed using validated instrument: PROMIS Global Health (PROMIS-GH) (T-score standardized, mean 50), where higher scores indicate better overall health status Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes. |
Baseline, 6 months, 12 months, and 18 months
|
|
Change in Patient-Reported Outcomes Measured by SAA
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in patient-reported outcomes assessed using validated instrument: Sexual Activity Avoidance (SAA), where higher scores indicate greater avoidance of sexual activity Changes in scores over time will be evaluated to assess symptom burden, quality of life, and functional outcomes. |
Baseline, 6 months, 12 months, and 18 months
|
|
Change in Patient-Reported Outcomes Measured by WPAI:SHP
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Change from baseline in patient-reported outcomes assessed using validated instrumens: Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) (0-100%), where higher percentages indicate greater impairment Changes in score over time will be evaluated to assess symptom burden, quality of life, and functional outcomes. |
Baseline, 6 months, 12 months, and 18 months
|
|
Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2.
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Ulcerative Colitis Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission. |
Baseline, 6 months, 12 months, and 18 months
|
|
Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2.
Prazo: Baseline, 6 months, 12 months, and 18 months
|
Proportion of participants achieving clinical remission based on validated patient-reported outcome measures: Crohn's Disease Patient-Reported Outcome 2 (UC PRO2), composed of: Stool frequency score (range 0-3) Rectal bleeding score (range 0-3) Lower scores indicate less disease activity; clinical remission is defined as rectal bleeding score = 0 and stool frequency score ≤1 These thresholds represent minimal or no symptoms consistent with clinical remission.
|
Baseline, 6 months, 12 months, and 18 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Casey Chapman, MD, GIA
- Investigador principal: Nicholas Lazarou, MPH, MBA, Cardinal Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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 Intestinais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Gastroenterite
- Doenças Inflamatórias Intestinais
- Colite
- Colite ulcerativa
- Doença de Crohn
- Peptídeos
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Fatores biológicos
- Peptídeos e proteínas de sinalização intercelular
- Citocinas
- Interleukins
- Interleucina-12
- Interleucina-23
- Mirikizumab
Outros números de identificação do estudo
- 103899
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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