Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

Study Overview
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Brief Summary
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To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.

Official Title
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A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must voluntarily sign and date a patient authorization. Patient must be ≥ 18 years of age. Patient must have confirmed diagnosis of UC. Patient must have: a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr. Patient must have been prescribed adalimumab as part of his treatment by his treating physician. If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice. Exclusion Criteria: Patient has previously received adalimumab. Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time (primary non-responder) unless they experienced a treatment limiting reaction. Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery. Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease. Patient with other tumor necrosis factor (TNF) immune-modulated disease. Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. A female patient is pregnant or breast-feeding. Patient is currently participating in another prospective study including controlled clinical trials and observational studies

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 |
| --- | --- |
| Open-label cohort<br>Patients will be followed for 52 weeks post initiation of adalimumab (Week 0). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms at Week 52 | It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9). | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depressive symptoms at Week 8 | It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9). | From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in the proportion of patients with PHQ-9 >= 10 | The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52. | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Disability | It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52. | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Overall quality of life | It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52. | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Ulcerative Colitis (UC)-specific quality of life | It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52. | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Fatigue | It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52. | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Sleep impairment, | It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52. | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Work productivity | The change from baseline in work productivity is assessed at week 8 and 52. | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Assessing Simple Clinical Colitis Activity Index (SCCAI) | SCCAI is used to access response and remission rates. | Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Fecal Calprotectin levels | The change from baseline in Fecal Calprotectin levels will be assessed. | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Mayo endoscopic sub-score | Mayo endoscopic sub-score will be assessed. | Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Proportion of patients with Complications including hospitalization and surgery | The proportion of patients with complications including hospitalization and surgery will be assessed. | At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Proportion of patients on steroids | The proportion of patients on steroids will be assessed. | At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 
| Change from baseline in Physician's Global Assessment (PGA) | The change from baseline in Physician's Global Assessment (PGA) will be assessed. | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adalimumab, Real-life effect, Patient reported outcomes (PRO), Moderate to severe ulcerative colitis (UC), Ulcerative colitis (UC)