Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT02506179
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in depressive symptoms at Week 52 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
Name Time Method 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 It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.
Change from baseline in Sleep impairment, 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.
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 The change from baseline in the proportion of patients with PHQ-9 \>= 10 is assessed at week 8 and 52.
Change from baseline in Physician's Global Assessment (PGA) 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.
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 It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.
Assessing Simple Clinical Colitis Activity Index (SCCAI) 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.
Proportion of patients with Complications including hospitalization and surgery 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.
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 It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).
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 It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.
Change from baseline in Fatigue 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.
Change from baseline in Work productivity 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.
Change from baseline in Fecal Calprotectin levels 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.
Proportion of patients on steroids 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.
Mayo endoscopic sub-score 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.
Trial Locations
- Locations (23)
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
CHUM - Hopital Saint-Luc /ID# 139393
🇨🇦Montreal, Quebec, Canada
CHUS - Hopital Fleurimont /ID# 137840
🇨🇦Sherbrooke, Quebec, Canada
Columbia Gastro Mgmnt Ltd /ID# 136820
🇨🇦New Westminster, British Columbia, Canada
McGill Univ HC /ID# 136821
🇨🇦Montreal, Quebec, Canada
GIRI Gastrointestinal Research Institute /ID# 141107
🇨🇦Vancouver, British Columbia, Canada
University of Calgary /ID# 144032
🇨🇦Calgary, Alberta, Canada
Dr. Everett Chalmers Reg Hosp. /ID# 136534
🇨🇦Fredericton, New Brunswick, Canada
Dr Chadwick Ian Williams Professional Corporation /ID# 144802
🇨🇦St. John, New Brunswick, Canada
CHU de Quebec-Universite Laval /ID# 147557
🇨🇦Quebec City, Quebec, Canada
Zeidler Ledcor Centre /ID# 145973
🇨🇦Edmonton, Alberta, Canada
Royal Univ. Hosp, Saskatoon,CA /ID# 137838
🇨🇦Saskatoon, Saskatchewan, Canada
Discovery Clinical Services /ID# 144102
🇨🇦Victoria, British Columbia, Canada
Hopital Hotel-Dieu de Levis /ID# 137099
🇨🇦Levis, Quebec, Canada
Hospital Maisonneuve-Rosemont /ID# 137336
🇨🇦Montreal, Quebec, Canada
Clinique MEDI-CLE /ID# 153690
🇨🇦Montreal, Quebec, Canada
Percuro Clinical Research, Ltd /ID# 136533
🇨🇦Victoria, British Columbia, Canada