Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

NCT02506179 | Completed

• 1 other identifier: P15-325
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 23

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.

Conditions

Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in depressive symptoms at Week 52

  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 Outcomes (14)

• Change from baseline in depressive symptoms at Week 8

  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

  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

  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

  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

  From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Study Arms (1)

Open-label cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead
• Cato Research: collaborator

Study Sites (23)

University of Calgary /ID# 144032

Calgary, Alberta, T2N 4Z6, Canada

Location

Zeidler Ledcor Centre /ID# 145973

Edmonton, Alberta, T6G 2X8, Canada

Location

Columbia Gastro Mgmnt Ltd /ID# 136820

New Westminster, British Columbia, V3L 3W5, Canada

Location

GIRI Gastrointestinal Research Institute /ID# 141107

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Discovery Clinical Services /ID# 144102

Victoria, British Columbia, V8T 5G4, Canada

Location

Percuro Clinical Research, Ltd /ID# 136533

Victoria, British Columbia, V8V 3M9, Canada

Location

Dr. Everett Chalmers Reg Hosp. /ID# 136534

Fredericton, New Brunswick, E3B 5N5, Canada

Location

Dr Chadwick Ian Williams Professional Corporation /ID# 144802

Saint John, New Brunswick, E2K 1J5, Canada

Location

Bellini Medicine Professional /ID# 144241

Brampton, Ontario, L6S 0C1, Canada

Location

Oshawa Clinic /ID# 144364

Oshawa, Ontario, L1H 1B9, Canada

Location

The Ottawa Hospital /ID# 139392

Ottawa, Ontario, K1H 8L6, Canada

Location

Kensington Screening Clinic /ID# 141106

Toronto, Ontario, M53 TA9, Canada

Location

Mount Sinai Hosp.-Toronto /ID# 141108

Toronto, Ontario, M5G 1X5, Canada

Location

Dr O Tarabain Medicine Prof Corp /ID# 144034

Windsor, Ontario, N8W 1E6, Canada

Location

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

Windsor, Ontario, N8Y 4C9, Canada

Location

Hopital Hotel-Dieu de Levis /ID# 137099

Lévis, Quebec, G6V 3Z1, Canada

Location

Hospital Maisonneuve-Rosemont /ID# 137336

Montreal, Quebec, H1T 2M4, Canada

Location

CHUM - Hopital Saint-Luc /ID# 139393

Montreal, Quebec, H2X 3J4, Canada

Location

McGill Univ HC /ID# 136821

Montreal, Quebec, H3G 1A4, Canada

Location

Clinique MEDI-CLE /ID# 153690

Montreal, Quebec, H3P 3E5, Canada

Location

CHU de Quebec-Universite Laval /ID# 147557

Québec, Quebec, G1R 2J6, Canada

Location

CHUS - Hopital Fleurimont /ID# 137840

Sherbrooke, Quebec, J1H 5N4, Canada

Location

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

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 23, 2015
• Study Start: August 18, 2015
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

CA (23)