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

January 22, 2021 updated by: AbbVie

A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary /ID# 144032
      • Edmonton, Alberta, Canada, T6G 2X8
        • Zeidler Ledcor Centre /ID# 145973
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Columbia Gastro Mgmnt Ltd /ID# 136820
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI Gastrointestinal Research Institute /ID# 141107
      • Victoria, British Columbia, Canada, V8T 5G4
        • Discovery Clinical Services /ID# 144102
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 136533
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5N5
        • Dr. Everett Chalmers Reg Hosp. /ID# 136534
      • St. John, New Brunswick, Canada, E2K 1J5
        • Dr Chadwick Ian Williams Professional Corporation /ID# 144802
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C1
        • Bellini Medicine Professional /ID# 144241
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic /ID# 144364
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital /ID# 139392
      • Toronto, Ontario, Canada, M53 TA9
        • Kensington Screening Clinic /ID# 141106
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hosp.-Toronto /ID# 141108
      • Windsor, Ontario, Canada, N8W 1E6
        • Dr O Tarabain Medicine Prof Corp /ID# 144034
      • Windsor, Ontario, Canada, N8Y 4C9
        • Dr. Rahman Bacchus Med. Corp. /ID# 141780
    • Quebec
      • Levis, Quebec, Canada, G6V 3Z1
        • Hopital Hotel-Dieu de Levis /ID# 137099
      • Montreal, Quebec, Canada, H1T 2M4
        • Hospital Maisonneuve-Rosemont /ID# 137336
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - Hopital Saint-Luc /ID# 139393
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill Univ HC /ID# 136821
      • Montreal, Quebec, Canada, H3P 3E5
        • Clinique MEDI-CLE /ID# 153690
      • Quebec City, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval /ID# 147557
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS - Hopital Fleurimont /ID# 137840
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal Univ. Hosp, Saskatoon,CA /ID# 137838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in depressive symptoms at Week 52
Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in depressive symptoms at Week 8
Time Frame: From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in the proportion of patients with PHQ-9 >= 10
Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Disability
Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Overall quality of life
Time Frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Ulcerative Colitis (UC)-specific quality of life
Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fatigue
Time Frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Sleep impairment,
Time Frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Work productivity
Time Frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in work productivity is assessed at week 8 and 52.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Assessing Simple Clinical Colitis Activity Index (SCCAI)
Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
SCCAI is used to access response and remission rates.
Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Fecal Calprotectin levels
Time Frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in Fecal Calprotectin levels will be assessed.
From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score
Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score will be assessed.
Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients with Complications including hospitalization and surgery
Time Frame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The proportion of patients with complications including hospitalization and surgery will be assessed.
At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients on steroids
Time Frame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The proportion of patients on steroids will be assessed.
At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in Physician's Global Assessment (PGA)
Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
The change from baseline in Physician's Global Assessment (PGA) will be assessed.
From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2015

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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