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Completed

NCT Number: NCT02506179

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary /ID# 144032, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Cato Research

Registry information

Official study title

A Study of the Impact of Adalimumab on Patient-reported Outcomes (PROs) in Canadian Patients Suffering From Moderate-to-severe Ulcerative Colitis (UCanADA)

Acronym: UCanADA

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 23, 2015
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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