Ulcerative Colitis
Conditions
Keywords
Real-life effect, Adalimumab, Patient reported outcomes (PRO), Moderate to severe ulcerative colitis (UC), Ulcerative colitis (UC)
Brief summary
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.
Interventions
None listed
Sponsors
Cato Research
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in depressive symptoms at Week 52 | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the proportion of patients with PHQ-9 >= 10 | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The change from baseline in the proportion of patients with PHQ-9 \>= 10 is assessed at week 8 and 52. |
| Change from baseline in Disability | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52. |
| Change from baseline in Overall quality of life | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52. |
| Change from baseline in Ulcerative Colitis (UC)-specific quality of life | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52. |
| Change from baseline in Fatigue | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52. |
| Change from baseline in Sleep impairment, | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52. |
| Change from baseline in depressive symptoms at Week 8 | From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9). |
| Assessing Simple Clinical Colitis Activity Index (SCCAI) | Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | SCCAI is used to access response and remission rates. |
| Change from baseline in Fecal Calprotectin levels | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The change from baseline in Fecal Calprotectin levels will be assessed. |
| Mayo endoscopic sub-score | Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | Mayo endoscopic sub-score will be assessed. |
| Proportion of patients with Complications including hospitalization and surgery | At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The proportion of patients with complications including hospitalization and surgery will be assessed. |
| Proportion of patients on steroids | At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The proportion of patients on steroids will be assessed. |
| Change from baseline in Physician's Global Assessment (PGA) | From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The change from baseline in Physician's Global Assessment (PGA) will be assessed. |
| Change from baseline in Work productivity | From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation | The change from baseline in work productivity is assessed at week 8 and 52. |
Countries
Canada
Outcome results
None listed