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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02506179
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
Cato Research
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date June 26, 2015
First Posted Date July 23, 2015
Last Update Posted Date January 25, 2021
Actual Study Start Date August 18, 2015
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2018)
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).
Original Primary Outcome Measures
 (submitted: July 21, 2015)
Change in Psychological Distress assessed using Patient Health Questionnaire 9 Questions (PHQ-9) [ Time Frame: From Week 0 to Week 52 or at the time of Premature Discontinuation ]
This instrument self-administered version of the depression scale from the PRIME-MD (Primary Care Evaluation of Mental Disorders) instrument and is used to assess the level of depression severity (for initial treatment decisions) as well as an outcome tool (to determine treatment response). The PHQ-9 contains 9 items, each of which is scored 0 to 3, providing a 0 to 27 severity score. Cutpoints of 5, 10, and 15 represent mild, moderate, and severe levels of depressive symptoms, respectively. The final question on the PHQ-9 allow obtaining the patient's global impression of symptom-related impairment.
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2018)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: July 21, 2015)
  • Change in Health Related-QOL (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 ]
    Validated instruments filled both by the patient and the treating physician.
  • Clinical Endpoints 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 ]
    Used to access response and remission rates
  • Change in productivity [ Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Validated instruments filled both by the patient and the treating physician
  • Change in functionality [ Time Frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Validated instruments filled both by the patient and the treating physician.
  • Mayo endoscopic sub-score [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation. ]
    Used to access response and remission rates
  • Lab parameters: C-reactive protein (CRP) milligram/ liter (mg/L) [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
  • Lab parameters: Hemoglobin (Hb) gram/ liter (g/L) [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
  • Lab parameters: Albumin (Ab) gram/ liter (g/L) [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
  • Lab parameters: White Blood Count (WBC) 10^9/Liter [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
  • Lab parameters: Platelets 10^9/Liter [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
  • Lab parameters: Calprotectin microgram/ gram (µg/g) [ Time Frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation ]
    Used to access response and remission rates
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
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)
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ulcerative Colitis
Intervention Not Provided
Study Groups/Cohorts Open-label cohort
Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2018)
100
Original Estimated Enrollment
 (submitted: July 21, 2015)
200
Actual Study Completion Date February 10, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02506179
Other Study ID Numbers P15-325
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor AbbVie
Original Study Sponsor Same as current
Collaborators Cato Research
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date January 2021