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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab Clinical Care Pathway | Active Comparator | 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. |
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| Standard Biologic Therapy Clinical Care Pathway | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Mirikizumab administered according to approved dosing regimens for ulcerative colitis and Crohn's disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Requiring an Increase in IBD Disease Management | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Measured by Crohn's Disease PRO2 Scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorraine O'Donnell | Contact | 914-388-4907 | lorraine.odonnell@cardinalhealth.com | |
| Jessica Manzyuk | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Casey Chapman, MD | GIA | Principal Investigator |
| Nicholas Lazarou, MPH, MBA | Cardinal Health | Principal Investigator |
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This study does not plan to share Individual Participant Data (IPD)
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
| D018664 | Interleukin-12 |
| D053759 | Interleukin-23 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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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.
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| Anti-TNF agents | Drug | Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. |
|
| anti-integrin antibodies | Drug | Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. |
|
| IL-12 | Drug | Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. |
|
| IL-23 | Drug | Biologic therapies administered per routine clinical care, including anti-TNF agents, anti-integrins, IL-12/23 antagonists, and IL-23p19 antagonists. |
|
| Baseline, 6 months, 12 months, and 18 months |
| Change in Disease Activity Measured by Ulcerative Colitis PRO2 Scores | 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) | 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. | 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 | 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 | 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 | Time from initiation of index therapy to initiation of a subsequent therapy or discontinuation of index therapy. | Up to 18 months |
| Concomitant Medication Use | 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 | Duration of time patients remain free from corticosteroid use while receiving index therapy. | Up to 18 months |
| Healthcare Resource Utilization | Frequency and rate of IBD-related healthcare utilization | Up to 18 months |
| Change in Patient-Reported Outcomes Measured by SIBDQ | 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 | 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 | 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 | 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 | 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. | 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. | 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |