Fecal Calprotectin Levels, Quality of Life, and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Study Overview
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Brief Summary
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The objectives of this study are to explore the fecal calprotectin (fC) levels of UC patients under adalimumab therapy and the correlation with their general wellbeing (Quality of Life [QoL]), workability, and disease activity.

Detailed Description
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This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a adalimumab containing regimen has to be decided in advance and has to be current practice. The prescription of adalimumab is clearly separated from the decision to include the participant in this study.

Official Title
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Fecal Calprotectin Levels, Quality of Life and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Conditions
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Moderate to Severe Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (AZA/6-MP); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC Patients who are able to complete patients questionnaires (e.g., WPAI:UC and sIBDQ questionnaire) Patients must fulfill national and international guidelines for the use of biologic therapies in UC (Chest X-ray and Interferon-Gamma-Release Assay (IGRA) or tuberculin purified protein derivative (PPD)-skin test negative for tuberculosis). Patients who have been prescribed adalimumab in line with the European SmPC (Summary of Product Characteristics) Exclusion Criteria: Previous therapy with TNF-alpha (Tumor necrosis factor alpha) blocker No signed written authorization to use data Contraindication to adalimumab therapy according to the SmPC Patients with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or planned bowel surgery. Patients received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period. Pregnant patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate to Severe Ulcerative Colitis<br>Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire | The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity. | Baseline (Day 0) to Month 12 | 
| Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ) | The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients 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 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL. | Baseline (Day 0) to Month 12 | 
| Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score | A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]). | Baseline (Day 0) to Month 12 | 
| Correlation Between fC and Disease Activity Determined by Partial Mayo Score | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA). | Baseline (Day 0) to Month 12 | 
| Correlation Between fC and Patient's QoL Determined by the sIBDQ | fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients 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 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). | Baseline (Day 0) to Month 12 | 
| Correlation Between fC and Workability Determined by WPAI:UC Questionnaire | Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Baseline (Day 0) to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Inflammatory Bowel Syndrome, Adalimumab, Tumor necrosis factor (TNF) alpha Antibody, Calprotectin