Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
NCT ID: NCT02506179
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2015-08-18
2020-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Cato Research
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Calgary /ID# 144032
Calgary, Alberta, Canada
Zeidler Ledcor Centre /ID# 145973
Edmonton, Alberta, Canada
Columbia Gastro Mgmnt Ltd /ID# 136820
New Westminster, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 141107
Vancouver, British Columbia, Canada
Discovery Clinical Services /ID# 144102
Victoria, British Columbia, Canada
Percuro Clinical Research, Ltd /ID# 136533
Victoria, British Columbia, Canada
Dr. Everett Chalmers Reg Hosp. /ID# 136534
Fredericton, New Brunswick, Canada
Dr Chadwick Ian Williams Professional Corporation /ID# 144802
Saint John, New Brunswick, Canada
Bellini Medicine Professional /ID# 144241
Brampton, Ontario, Canada
Oshawa Clinic /ID# 144364
Oshawa, Ontario, Canada
The Ottawa Hospital /ID# 139392
Ottawa, Ontario, Canada
Kensington Screening Clinic /ID# 141106
Toronto, Ontario, Canada
Mount Sinai Hosp.-Toronto /ID# 141108
Toronto, Ontario, Canada
Dr O Tarabain Medicine Prof Corp /ID# 144034
Windsor, Ontario, Canada
Dr. Rahman Bacchus Med. Corp. /ID# 141780
Windsor, Ontario, Canada
Hopital Hotel-Dieu de Levis /ID# 137099
Lévis, Quebec, Canada
Hospital Maisonneuve-Rosemont /ID# 137336
Montreal, Quebec, Canada
CHUM - Hopital Saint-Luc /ID# 139393
Montreal, Quebec, Canada
McGill Univ HC /ID# 136821
Montreal, Quebec, Canada
Clinique MEDI-CLE /ID# 153690
Montreal, Quebec, Canada
CHU de Quebec-Universite Laval /ID# 147557
Québec, Quebec, Canada
CHUS - Hopital Fleurimont /ID# 137840
Sherbrooke, Quebec, Canada
Royal Univ. Hosp, Saskatoon,CA /ID# 137838
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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P15-325
Identifier Type: -
Identifier Source: org_study_id
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