Ulcerative ColitisUCanADANCT02506179
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by AbbVie at 23 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 100 participants
- Where
- 23 sitesCanada
- Study dates
- 18 Aug 2015to 10 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Canada23 sites
Bellini Medicine Professional /ID# 144241
Brampton, Ontario, L6S 0C1
University of Calgary /ID# 144032
Calgary, Alberta, T2N 4Z6
Zeidler Ledcor Centre /ID# 145973
Edmonton, Alberta, T6G 2X8
Dr. Everett Chalmers Reg Hosp. /ID# 136534
Fredericton, New Brunswick, E3B 5N5
Hopital Hotel-Dieu de Levis /ID# 137099
Lévis, Quebec, G6V 3Z1
Hospital Maisonneuve-Rosemont /ID# 137336
Montreal, Quebec, H1T 2M4
CHUM - Hopital Saint-Luc /ID# 139393
Montreal, Quebec, H2X 3J4
McGill Univ HC /ID# 136821
Montreal, Quebec, H3G 1A4
Clinique MEDI-CLE /ID# 153690
Montreal, Quebec, H3P 3E5
Columbia Gastro Mgmnt Ltd /ID# 136820
New Westminster, British Columbia, V3L 3W5
Oshawa Clinic /ID# 144364
Oshawa, Ontario, L1H 1B9
The Ottawa Hospital /ID# 139392
Ottawa, Ontario, K1H 8L6
CHU de Quebec-Universite Laval /ID# 147557
Québec, Quebec, G1R 2J6
Dr Chadwick Ian Williams Professional Corporation /ID# 144802
Saint John, New Brunswick, E2K 1J5
Royal Univ. Hosp, Saskatoon,CA /ID# 137838
Saskatoon, Saskatchewan, S7N 0W8
CHUS - Hopital Fleurimont /ID# 137840
Sherbrooke, Quebec, J1H 5N4
Kensington Screening Clinic /ID# 141106
Toronto, Ontario, M53 TA9
Mount Sinai Hosp.-Toronto /ID# 141108
Toronto, Ontario, M5G 1X5
GIRI Gastrointestinal Research Institute /ID# 141107
Vancouver, British Columbia, V6Z 2K5
Discovery Clinical Services /ID# 144102
Victoria, British Columbia, V8T 5G4
Percuro Clinical Research, Ltd /ID# 136533
Victoria, British Columbia, V8V 3M9
Dr O Tarabain Medicine Prof Corp /ID# 144034
Windsor, Ontario, N8W 1E6
Dr. Rahman Bacchus Med. Corp. /ID# 141780
Windsor, Ontario, N8Y 4C9
About this study
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)
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)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open-label cohort | Patients will be followed for 52 weeks post initiation of adalimumab (Week 0). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms at Week 52
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
Measured: 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
It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
Measured: 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
The change from baseline in the proportion of patients with PHQ-9 >= 10 is assessed at week 8 and 52.
Measured: 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
It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
Measured: 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
It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
Measured: 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
It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
Measured: 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
It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.
Measured: 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,
It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.
Measured: 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
The change from baseline in work productivity is assessed at week 8 and 52.
Measured: 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)
SCCAI is used to access response and remission rates.
Measured: 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
The change from baseline in Fecal Calprotectin levels will be assessed.
Measured: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Mayo endoscopic sub-score
Mayo endoscopic sub-score will be assessed.
Measured: 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
The proportion of patients with complications including hospitalization and surgery will be assessed.
Measured: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Proportion of patients on steroids
The proportion of patients on steroids will be assessed.
Measured: 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)
The change from baseline in Physician's Global Assessment (PGA) will be assessed.
Measured: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study start18 Aug 2015
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506179
- Sponsor's protocol ID
- P15-325
- Acronym
- UCanADA
- Status last verified
- Jan 2021
- First submitted
- 26 Jun 2015
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02506179
- Acronym / sponsor ID
- UCanADA / P15-325
- Conditions
- Ulcerative Colitis
- Keywords
- Real-life effect, Adalimumab, Patient reported outcomes (PRO), Moderate to severe ulcerative colitis (UC), Ulcerative colitis (UC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label cohort | – | –Patients will be followed for 52 weeks post initiation of adalimumab (Week 0). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
14 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Mayo endoscopic sub-score
Time frame: 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
Proportion of patients on steroids
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by AbbVie at 23 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.