Have you or your loved ones been diagnosed with ulcerative colitis?
You may be eligible to participate in a ulcerative colitis clinical trial.
Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Have you or your loved ones been diagnosed with ulcerative colitis?
You may be eligible to participate in a ulcerative colitis clinical trial.
Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.
Completed
Male & Female
18 Years +
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.
Details for the study
Population
Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.
Brief Title
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
Official Title
A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)
Brief Summary
To evaluate the real-life effect after 1 year of adalimumab treatment on psychological<br /> distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Change from baseline in depressive symptoms at Week 52
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
Secondary
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.
Secondary
Mayo endoscopic sub-score
Mayo endoscopic sub-score will be assessed.
Secondary
Change from baseline in Fatigue
It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
Secondary
Change from baseline in Sleep impairment,
It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
Secondary
Change from baseline in Work productivity
The change from baseline in work productivity is assessed at week 8 and 52.
Secondary
Change from baseline in depressive symptoms at Week 8
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
Secondary
Assessing Simple Clinical Colitis Activity Index (SCCAI)
SCCAI is used to access response and remission rates.
Secondary
Change from baseline in Fecal Calprotectin levels
The change from baseline in Fecal Calprotectin levels will be assessed.
Secondary
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.
Secondary
Proportion of patients with Complications including hospitalization and surgery
The proportion of patients with complications including hospitalization and surgery will be assessed.
Secondary
Change from baseline in Physician's Global Assessment (PGA)
The change from baseline in Physician's Global Assessment (PGA) will be assessed.
Secondary
Change from baseline in Disability
It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
Secondary
Proportion of patients on steroids
The proportion of patients on steroids will be assessed.
Secondary
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.
Study Criteria
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: 1. 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 2. 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