UCanADA

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

Status:
Completed
Conditions:
Ulcerative Colitis
Enrollment:
100 patients
Protocol ID:
P15-325
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

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

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 2X8
New Westminster - V3L 3W5
Vancouver - V6Z 2K5
Victoria - V8T 5G4
Victoria - V8V 3M9
Brampton - L6S 0C1
Oshawa - L1H 1B9
Ottawa - K1H 8L6
Toronto - M5G 1X5
Toronto - M53 TA9
Windsor - N8W 1E6
Windsor - N8Y 4C9
Levis - G6V 3Z1
Montreal - H1T 2M4
Montreal - H3G 1A4
Montreal - H3P 3E5
Montreal - H2X 3J4
Quebec City - G1R 2J6
Quebec City - G1R 2J6
Sherbrooke - J1H 5N4
Saskatoon - S7N 0W8
Fredericton - E3B 5N5
St. John - E2K 1J5