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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Other | Open Label Mirikizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab - Intravenous (IV) | Drug | 300 mg mirikizumab at Weeks 0, 4, and 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI) | The Pouchitis Disease Activity Index (PDAI) was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The PDAI includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever, endoscopic criteria, and histologic criteria through biopsies. The PDAI was modified to omit the biopsy and histology costs. The mPDAI includes the clinical portion and the endoscopic subscore of the PDAI. Score range is 0-12. The higher the score, the worse the disease activity. mPDAI remission is defined as an mPDAI score of 4 or lower and a reduction from baseline of 2 or more points in the mPDAI total score. | Weeks 0, 24, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Median change in the Endoscopic Pouch Score (EPS) | The endoscopic pouch score (EPS) is a standardized assessment of inflammation in the pouch of patients with an ileal pouch anal anastomosis (IPAA), including those with inflammation outside the pouch body. The EPS is a novel method of endoscopic scoring that has been developed to offer more granular longitudinal assessments of response to advanced therapies in patients with inflammatory conditions of the pouch. Score range is 0-45. The higher the score, the worse the disease activity. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikki Sandridge | Contact | 919-843-3873 | mikki_sandridge@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edward Barnes, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Vatche & Tamar Manoukian Division of Digestive Diseases | Recruiting | Los Angeles | California | 90024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30295784 | Background | Weaver KN, Gregory M, Syal G, Hoversten P, Hicks SB, Patel D, Christophi G, Beniwal-Patel P, Isaacs KL, Raffals L, Deepak P, Herfarth HH, Barnes EL. Ustekinumab Is Effective for the Treatment of Crohn's Disease of the Pouch in a Multicenter Cohort. Inflamm Bowel Dis. 2019 Mar 14;25(4):767-774. doi: 10.1093/ibd/izy302. | |
| 30810748 |
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Deidentified individual data that supports the results will be shared beginning 9 to 12 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
beginning 9 and continuing for 12 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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Interventional Study, open-label real-world observational study
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| Mirikizumab - Subcutaneous (SC) | Drug | Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. |
|
|
| Weeks 0, 24, and 52 |
| Median change in the endoscopic subscore of the mPDAI | The endoscopic subscore of the PDAI is a component of the PDAI that assesses endoscopic findings of pouchitis. Score range is 0-6. The higher the score, the worse the disease activity. | Weeks 0, 24, and 52 |
| Change in Cleveland Clinic Global Quality of Life (QoL) scale | The Cleveland Clinic Global Quality of Life scale asks the patient to rate their current QoL, current quality of health, and current energy level using a 1-10 rating (where 10 is best). The score on each of these 3 components is added and the final Cleveland Clinic Global Quality of Life utility score can be obtained by dividing this result by 30. A higher score means improved quality of life. | Weeks 0, 4, 8, 12, 24, 38, and 52 |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measures | The PROMIS measure for incontinence includes 4 items that assess the frequency of bowel incontinence, soiling, stool leakage, and stool leakage while passing gas over the past 7 days. Score range is 0-20, where a higher score means increased incontinence. | Weeks 0, 4, 8, 12, 24, 38, and 52 |
| Change in Urgency Numeric Rating Scale (NRS) | Urgency will be measured by the 11-point Likert scale urgency question as validated in the mirikizumab clinical trials. Score range is 0-10. The higher the score, the worse the urgency. | Weeks 0, 4, 8, 12, 24, 38, and 52 |
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
|
| University of North Carolina | Recruiting | Chapel Hill | North Carolina | 27599-7080 | United States |
|
| Allegheny Health Network | Not yet recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Gregory M, Weaver KN, Hoversten P, Hicks SB, Patel D, Ciorba MA, Gutierrez AM, Beniwal-Patel P, Palam S, Syal G, Herfarth HH, Christophi G, Raffals L, Barnes EL, Deepak P. Efficacy of Vedolizumab for Refractory Pouchitis of the Ileo-anal Pouch: Results From a Multicenter US Cohort. Inflamm Bowel Dis. 2019 Aug 20;25(9):1569-1576. doi: 10.1093/ibd/izz030. |
| 31187322 | Background | Ollech JE, Rubin DT, Glick L, Weisshof R, El Jurdi K, Israel A, Krugliak Cleveland N, Hyman N, Sakuraba A, Pekow J, Cohen RD, Dalal SR. Ustekinumab Is Effective for the Treatment of Chronic Antibiotic-Refractory Pouchitis. Dig Dis Sci. 2019 Dec;64(12):3596-3601. doi: 10.1007/s10620-019-05697-1. Epub 2019 Jun 11. |
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| 37975591 | Background | Kayal M, Deepak P, Beniwal-Patel P, Raffals L, Dubinsky M, Chang S, Higgins PDR, Jiang Y, Cross RK, Long MD, Herfarth HH, Barnes EL. Changes in Therapy Are Not Associated With Increased Remission in Patients With Crohn's Disease of the Pouch. Am J Gastroenterol. 2024 Mar 1;119(3):584-587. doi: 10.14309/ajg.0000000000002599. Epub 2023 Nov 17. |
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| 38125203 | Background | Barnes EL, Boynton MH, DeWalt DA, Herfarth HH, Kappelman MD. Patient Reported Outcome Assessments Used in the Evaluation of Patients after Ileal Pouch-Anal Anastomosis: A Systematic Review. Gastro Hep Adv. 2023;2(8):1044-1049. doi: 10.1016/j.gastha.2023.07.010. Epub 2023 Jul 29. |
| 3393032 | Background | Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available. |
| 36777426 | Background | Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul. |
| 37782274 | Background | Barnes EL. A Practical Guide to the Use of Mirikizumab. Am J Gastroenterol. 2024 Mar 1;119(3):400-403. doi: 10.14309/ajg.0000000000002531. Epub 2023 Oct 2. No abstract available. |
| Background | European Medicines Agency: Vedolizumab. |
| ID | Term |
|---|---|
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |
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