Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis (UCanADA)

AbbVie

Status: Completed

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02506179

P15-325

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Open-label cohort

Description:

Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).