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

• ClinicalTrials.gov Identifier: NCT02506179
• Recruitment Status: Completed
• First Posted: July 23, 2015
• Last Update Posted: January 25, 2021
• Sponsor: AbbVie
• Collaborator: Cato Research
• Information provided by (Responsible Party): AbbVie

Study Description

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.

Condition or disease
Ulcerative Colitis

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: August 18, 2015
• Actual Primary Completion Date: February 10, 2020
• Actual Study Completion Date: February 10, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

Canada, Alberta

University of Calgary /ID# 144032

Calgary, Alberta, Canada, T2N 4Z6

Zeidler Ledcor Centre /ID# 145973

Edmonton, Alberta, Canada, T6G 2X8

Canada, British Columbia

Columbia Gastro Mgmnt Ltd /ID# 136820

New Westminster, British Columbia, Canada, V3L 3W5

GIRI Gastrointestinal Research Institute /ID# 141107

Vancouver, British Columbia, Canada, V6Z 2K5

Discovery Clinical Services /ID# 144102

Victoria, British Columbia, Canada, V8T 5G4

Percuro Clinical Research, Ltd /ID# 136533

Victoria, British Columbia, Canada, V8V 3M9

Canada, New Brunswick

Dr. Everett Chalmers Reg Hosp. /ID# 136534

Fredericton, New Brunswick, Canada, E3B 5N5

Dr Chadwick Ian Williams Professional Corporation /ID# 144802

St. John, New Brunswick, Canada, E2K 1J5

Canada, Ontario

Bellini Medicine Professional /ID# 144241

Brampton, Ontario, Canada, L6S 0C1

Oshawa Clinic /ID# 144364

Oshawa, Ontario, Canada, L1H 1B9

The Ottawa Hospital /ID# 139392

Ottawa, Ontario, Canada, K1H 8L6

Kensington Screening Clinic /ID# 141106

Toronto, Ontario, Canada, M53 TA9

Mount Sinai Hosp.-Toronto /ID# 141108

Toronto, Ontario, Canada, M5G 1X5

Dr O Tarabain Medicine Prof Corp /ID# 144034

Windsor, Ontario, Canada, N8W 1E6

Dr. Rahman Bacchus Med. Corp. /ID# 141780

Windsor, Ontario, Canada, N8Y 4C9

Canada, Quebec

Hopital Hotel-Dieu de Levis /ID# 137099

Levis, Quebec, Canada, G6V 3Z1

Hospital Maisonneuve-Rosemont /ID# 137336

Montreal, Quebec, Canada, H1T 2M4

CHUM - Hopital Saint-Luc /ID# 139393

Montreal, Quebec, Canada, H2X 3J4

McGill Univ HC /ID# 136821

Montreal, Quebec, Canada, H3G 1A4

Clinique MEDI-CLE /ID# 153690

Montreal, Quebec, Canada, H3P 3E5

CHU de Quebec-Universite Laval /ID# 147557

Quebec City, Quebec, Canada, G1R 2J6

CHUS - Hopital Fleurimont /ID# 137840

Sherbrooke, Quebec, Canada, J1H 5N4

Canada, Saskatchewan

Royal Univ. Hosp, Saskatoon,CA /ID# 137838

Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

AbbVie

Cato Research

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

Additional Information:

clinical study report synopsis 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02506179
• Other Study ID Numbers: P15-325
• First Posted: July 23, 2015
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Keywords provided by AbbVie:

Real-life effect; Adalimumab; Patient reported outcomes (PRO); Moderate to severe ulcerative colitis (UC); Ulcerative colitis (UC)

Additional relevant MeSH terms:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases