Crohn Disease (CD), Ulcerative Colitis (UC)
Conditions
Brief summary
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
Interventions
DRUGMirikizumab
Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease.
DRUGAnti-TNF agents
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.
DRUGIL-12
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
DRUGIL-23
Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists.
Sponsors
Specialty Networks Research.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a cluster randomized, parallel-group study in which participating community gastroenterology practices are randomized to either a mirikizumab treatment pathway or a standard biologic therapy pathway. All eligible patients enrolled at a given site receive the treatment assigned to that site. Patients are followed prospectively under routine clinical care without crossover between treatment groups.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Requiring an Increase in IBD Disease Management | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Measured by Crohn's Disease PRO2 Scores | 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. |
| Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores | 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. |
| Proportion of Participants Achieving Endoscopic Remission Measured by Simple Endoscopic Score for Crohn's Disease (SES-CD) | 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. |
| Proportion of Participants Achieving Endoscopic Remission Measured by Modified Baron Score. | 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. |
| Treatment Persistence | 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. |
| Proportion of Patients with Dose Escalation | Up to 18 months | Proportion of patients who discontinue index therapy and/or initiate a subsequent IBD therapy during the study period. |
| Time to Next Treatment | Up to 18 months | Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy. |
| Concomitant Medication Use | Baseline through 18 months | Proportion of patients receiving concomitant corticosteroids, immunomodulators, or aminosalicylates at baseline and during follow-up, including initiation and discontinuation patterns. |
| Corticosteroid-Free Time | Up to 18 months | Duration of time patients remain free from corticosteroid use while receiving index therapy. |
| Healthcare Resource Utilization | Up to 18 months | Frequency and rate of IBD-related healthcare utilization |
| Change in Patient-Reported Outcomes Measured by SIBDQ | 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. |
| Change in Patient-Reported Outcomes Measured by UNRS | 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. |
| Change in Patient-Reported Outcomes Measured by PROMIS Global Health | 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. |
| Change in Patient-Reported Outcomes Measured by SAA | 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. |
| Change in Patient-Reported Outcomes Measured by WPAI:SHP | 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. |
| Proportion of Participants Achieving Clinical Remission Based on Ulcerative Colitis PRO2. | 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. |
| Proportion of Participants Achieving Clinical Remission Based on Crohn's Disease PRO2. | 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. |
Contacts
CONTACTLorraine O'Donnell
CONTACTJessica Manzyuk
PRINCIPAL_INVESTIGATORCasey Chapman, MD
GIA
PRINCIPAL_INVESTIGATORNicholas Lazarou, MPH, MBA
Cardinal Health
Outcome results
None listed