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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
300 mg mirikizumab at Weeks 0, 4, and 8
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
UCLA Vatche & Tamar Manoukian Division of Digestive Diseases
Los Angeles, California, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGNYU Langone Health
New York, New York, United States
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.
Time frame: Weeks 0, 24, and 52
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.
Time frame: 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.
Time frame: 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.
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University of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGAllegheny Health Network
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGTime frame: 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.
Time frame: 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.
Time frame: Weeks 0, 4, 8, 12, 24, 38, and 52