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

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ClinicalTrials.gov Identifier: NCT02506179
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : December 14, 2018
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
AbbVie

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 (UC)

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

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



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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506179


Contacts
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Contact: Kevin Mchugh +1 514-832-7438 kevin.mchugh@abbvie.com
Contact: Melanie Labelle melanie.labelle@abbvie.com

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

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02506179     History of Changes
Other Study ID Numbers: P15-325
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents