UCanADA
Brief summary
To evaluate the real-life effect after 1 year of an active drug treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.
Observational study
Age:
18 Years and older.
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