Impact of an Active Drug on Patient-reported Outcomes in Ulcerative Colitis

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

Ulcerative Colitis
100 patients
Protocol ID:
Observational model:
Time perspective:

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Eligibility criteria

Participant attributes:
Male and Female


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

- Patient must have been prescribed adalimumab as part of his treatment by his treating

- 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

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