The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.
Study Type
OBSERVATIONAL
Enrollment
200
University of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGClinical remission as evaluated by the Simple Clinical Colitis Activity Index (SCCAI) for the patient-reported outcomes.
The SCCAI is a 6-item that describes the symptoms and disease activity of a patient with UC at the time of assessment. A score of 0-4 is considered a clinical range of remission (but with more refined definitions of clinical remission with SCCAI ≤2 and very mild symptoms with a score \>2 ≤4), 5-7 mild activity, 8-16 moderate activity and \> 16 severe activity. A response will be defined as a decrease of the SCCAI score \< 5 points in patients with a baseline SCCAI ≥5.
Time frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52.
Clinical remission as evaluated by the Simple Crohn's Disease Activity Index (sCDAI for the patient-reported outcomes.
The Short Crohn's Disease Activity Index (sCDAI) is a simplified version of the Crohn's Disease Activity Index (CDAI), used to assess disease severity in Crohn's disease patients. It reduces the number of variables required, making it easier and quicker to use in clinical practice. Recent data demonstrated, that collections of the parameters on a single day equally reflects reliable disease activity compared to a collection of data over 7 consecutive days, which is often hampered by missing data. A score of \< 150, 150-219, 220-450 and \>450 reflects remission, mild, moderate and severe Crohn's disease activity.
Time frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52
Response as measured by the Simple Endoscopic Score for Crohn's disease (SES-CD)
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is a tool used to objectively measure the severity of Crohn's disease based on the extent and severity of ulcers, affected surface area, and luminal narrowing during an endoscopy. The total score is the sum of scores for these four features, and it is categorized as follows: 0-2 for remission, 3-6 for mild activity, 7-15 for moderate activity, and greater than 15 for severe activity. Mucosal healing will be defined by an SES-CD \< 4
Time frame: Through study completion, an average of 1 year
Response as measured by the endoscopic Mayo score for ulcerative colitis
The Mayo endoscopic score is a four-point scale (1 to 3) used to assess the severity of ulcerative colitis (UC) based on a colonoscopy. It evaluates the severity of inflammation through findings like erythema, vascular pattern, friability, erosions, and spontaneous bleeding, with higher scores indicating more severe disease. Mucosal healing will be defined by an endoscopic Mayo score \<1.
Time frame: Through study completion, an average of 1 year
Mucosal healing will be assessed in the setting of standard-of-care calprotectin levels.
Calprotectin is a surrogate marker of intestinal inflammation, and levels ≥ 250 mcg/g stool are associated with active mucosal inflammation, whereas levels \<150 mcg are considered to represent mild or no mucosal inflammation
Time frame: Weeks 0, 14, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Depression
PROMIS measure of depression measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores mean more severe depression. Differences in PROMIS scores compared to baseline will be assessed.
Time frame: Weeks 0, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Anxiety Score
PROMIS measure of anxiety measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores indicate greater anxiety severity Differences in PROMIS scores compared to baseline will be assessed.
Time frame: Weeks 0, 24, and 52.
Response as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) -Social Satisfaction Score
PROMIS measure of satisfaction measures well-being. This is calculated as T scores. A clinically meaningful difference is considered to be a change in T score of ≥ 2.5 (scores are normalized at 50 with a standard deviation of 10). Higher scores indicate greater satisfaction. Differences in PROMIS scores compared to baseline will be assessed.
Time frame: Weeks 0, 24, and 52.
Response as measured by Likert scale urgency Score
Urgency will be measured by the 11-point Likert scale urgency question. Score range is 0-10. The higher the score, the worse the urgency.
Time frame: Weeks 0,1, 2, 4, 6,10, 14, 18, 24, 36, and 52
Response as measured by Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale Score
Fatigue will be determined by the validated FACIT-F questionnaire. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. Score range is 0-52. The higher the score, the better the quality of life.
Time frame: Weeks 0, 24, and 52
Response as measured by The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score
The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
Time frame: Weeks 0,4,10,14,18,24,36 and 52.
Response as measured by The Work Productivity and Activity Impairment questionnaire (WPAI)
The WPAI was designed to measure absenteeism, presenteeism and activity impairment attributable to ill-health over the preceding 7 days. The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment.
Time frame: Weeks 0, 24, and 52
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