Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

INSIGHT-IBD Pragmatic Study

29 czerwca 2026 zaktualizowane przez: Specialty Networks Research.

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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

400

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

  • Nazwa: Jessica Manzyuk

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Lek: Mirikizumab
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
Aktywny komparator: 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.
Lek: Anti-TNF agents
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Lek: anti-integrin antibodies
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Lek: IL-12
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Lek: IL-23
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Patients Requiring an Increase in IBD Disease Management
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Disease Activity Measured by Crohn's Disease PRO2 Scores
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Up to 18 months
Duration of time patients remain free from corticosteroid use while receiving index therapy.
Up to 18 months
Healthcare Resource Utilization
Ramy czasowe: Up to 18 months
Frequency and rate of IBD-related healthcare utilization
Up to 18 months
Change in Patient-Reported Outcomes Measured by SIBDQ
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Specialty Networks Research.

Współpracownicy

Eli Lilly and Company

Śledczy

  • Główny śledczy: Casey Chapman, MD, GIA
  • Główny śledczy: Nicholas Lazarou, MPH, MBA, Cardinal Health

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

7 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

7 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 103899

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

This study does not plan to share Individual Participant Data (IPD)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Choroba Leśniowskiego-Crohna (CD)

Badania kliniczne na Mirikizumab

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in China

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj