Clinical trial NCT02506179: Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
Official title: A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Real-life effect
Adalimumab
Patient reported outcomes (PRO)
Moderate to severe ulcerative colitis (UC)
Ulcerative colitis (UC)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Cato Research
First posted: 2015-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms at Week 52
timeFrame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Secondary outcomes:
measure: Change from baseline in depressive symptoms at Week 8
timeFrame: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in the proportion of patients with PHQ-9 >= 10
timeFrame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Disability
timeFrame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Overall quality of life
timeFrame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Ulcerative Colitis (UC)-specific quality of life
timeFrame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Fatigue
timeFrame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Sleep impairment,
timeFrame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Work productivity
timeFrame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Assessing Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Fecal Calprotectin levels
timeFrame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Mayo endoscopic sub-score
timeFrame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Proportion of patients with Complications including hospitalization and surgery
timeFrame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Proportion of patients on steroids
timeFrame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
measure: Change from baseline in Physician's Global Assessment (PGA)
timeFrame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary /ID# 144032
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre /ID# 145973
state: Alberta
city: New Westminster
country: Canada
facility: Columbia Gastro Mgmnt Ltd /ID# 136820
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute /ID# 141107
state: British Columbia
city: Victoria
country: Canada
facility: Discovery Clinical Services /ID# 144102
state: British Columbia
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 136533
state: British Columbia
city: Fredericton
country: Canada
facility: Dr. Everett Chalmers Reg Hosp. /ID# 136534
state: New Brunswick
city: St. John
country: Canada
facility: Dr Chadwick Ian Williams Professional Corporation /ID# 144802
state: New Brunswick
city: Brampton
country: Canada
facility: Bellini Medicine Professional /ID# 144241
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Clinic /ID# 144364
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital /ID# 139392
state: Ontario
city: Toronto
country: Canada
facility: Kensington Screening Clinic /ID# 141106
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosp.-Toronto /ID# 141108
state: Ontario
city: Windsor
country: Canada
facility: Dr O Tarabain Medicine Prof Corp /ID# 144034
state: Ontario
city: Windsor
country: Canada
facility: Dr. Rahman Bacchus Med. Corp. /ID# 141780
state: Ontario
city: Levis
country: Canada
facility: Hopital Hotel-Dieu de Levis /ID# 137099
state: Quebec
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont /ID# 137336
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital Saint-Luc /ID# 139393
state: Quebec
city: Montreal
country: Canada
facility: McGill Univ HC /ID# 136821
state: Quebec
city: Montreal
country: Canada
facility: Clinique MEDI-CLE /ID# 153690
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Quebec-Universite Laval /ID# 147557
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont /ID# 137840
state: Quebec
city: Saskatoon
country: Canada
facility: Royal Univ. Hosp, Saskatoon,CA /ID# 137838
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: