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Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Mesalazine
Mesalazine
Sponsored by
Flemming Bendtsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Age between and including 18 and 60
  • Diagnosed with UC according to the Copenhagen Diagnostic Criteria
  • Length of disease of max. 10 years
  • Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
  • Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2

  • Have had a relapse within the last 2 years

    • Defined as the need of escalation of treatment or change medical treatment.

Exclusion Criteria:

  • Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
  • On immunomodulators, including methotrexate
  • On any biological therapy
  • Any previous abdominal surgery related to UC
  • Any chronic infections (e.g. HBV, HCV, HIV)
  • Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
  • Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
  • Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
  • Any previous documented allergic reaction to tested the medical drugs

Sites / Locations

  • Copenhagen University Hospital HvidovreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1600 mg Asacol (mesalazine)

800 mg Asacol (mesalazine)

Arm Description

1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year

800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year

Outcomes

Primary Outcome Measures

Medical Adherence
Measured by drug accountability log Patients having taken ≥80 % are categorised as adherent
Medical Adherence
Measured by "Medical adherence rating scale" (MARS) Medical adherence rating scale is a self-reported medical adherence tool consisting of 5 items scored on a 5 point Likert scale (ranging from 5-25). The scale has been used in several IBD studies and a global score > 20 indicates a good adherence.
Medical Adherence
Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women. Further detail see outcome 1 and 2

Secondary Outcome Measures

Assessment of disease activity by Mayo Score
The Mayo Score is composed of 4 items. A score from 0-2 is categorised as remission and 11-12 as severe.
Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)
The SCCAI rely solely on clinical assessments. Clinical remission are defined as SCCAI < 1 and clinical response as a change of at least 1 point.
Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
The UCEIS endoscopic severity on a scale of 1-4. Higher score mean worse disease severity.
Assessment of endoscopic severity by the Mayo endoscopic score
The Mayo endoscopic score is scored on a scale of 0-3. Higher score mean worse disease severity.
Assessment of histological severity by the Geboes score
The Geboes score is interpreted as such: a higher score means higher disease activity.
Assessment of histological severity by the Nancy Index
The Nancy Index are interpreted as such: The grade 4 correspond to severe disease, grade 0 as " absence of significant histological disease".
Assessment of histological severity by the Robarts Histopathology Index (RHI)
The RHI are interpreted as such: The score are ranging between 0 (no disease activity) to 33 (severe disease activity).
Correlation between the different clinical scores
Comparison, correlation and association between the different endoscopic, histological and disease activity indices. Included will be: Mayo score, Simple clinical colitis activity index (SCCAI), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), Nancy Index, Robarts Histopathology Index (RHI) and the Geboes score (see outcome 4-10).
Remission - days
Differences in number of days in remission during the trial
Relapse - days
Differences in number of days in relapse during the trial
Remission and relapse - episodes
Differences episodes of relapses during the trial
Changes in quality of life
Prospective analyses of quality of life using 12-Item Short Form Survey (SF12). The SF12 is measured on a global score from 12-56. Beside a global score, a mental and physical dimension will also be calculated.
Changes in disease specific quality of life
Prospective analyses quality of life using the Short inflammatory bowel disease questionnaire (SIBDQ) The SIBDQ is a quality of life (QOL) questionnaire ranging from 10-70. Higher score means better QOL.
Changes in disability among ulcerative colitis patients
Prospective analyses of disability using the Inflammatory bowel disease disability index (IBD-DI) The IBD-DI measures the disability among patients with inflammatory bowel disease. Higher scores means worse disability.
Changes in sleep quality
Prospective analyses of sleep using the Pittsburgh Sleep Quality Index (PSQI), The PSQI was designed to measure sleep quality and disturbance. A global score > 5 is considered poor sleep quality.
Changes in resilience
Prospective analyses of resilience using the Brief Resilience Scale (BRS) The BRS is designed to measure the ability to bounce back or recover from stressful events. Higher scores means higher resilience.

Full Information

First Posted
October 10, 2019
Last Updated
September 25, 2023
Sponsor
Flemming Bendtsen
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1. Study Identification

Unique Protocol Identification Number
NCT04133194
Brief Title
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
Acronym
EASI
Official Title
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Flemming Bendtsen

4. Oversight

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

5. Study Description

Brief Summary
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day. Primary purpose: • To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day [intervention]) improves adherence with preserved remission rates compared to conventional therapy. Secondary purposes: Compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group. Investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy. To assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers. Improve, correlate and assess patient-reported outcomes in a prospective manner. To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for identification of future biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1600 mg Asacol (mesalazine)
Arm Type
Experimental
Arm Description
1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year
Arm Title
800 mg Asacol (mesalazine)
Arm Type
Active Comparator
Arm Description
800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
1600 mg Asacol [mesalazine]
Intervention Type
Drug
Intervention Name(s)
Mesalazine
Intervention Description
800 mg Asacol [mesalazine]
Primary Outcome Measure Information:
Title
Medical Adherence
Description
Measured by drug accountability log Patients having taken ≥80 % are categorised as adherent
Time Frame
through study completion, an average of 2 year
Title
Medical Adherence
Description
Measured by "Medical adherence rating scale" (MARS) Medical adherence rating scale is a self-reported medical adherence tool consisting of 5 items scored on a 5 point Likert scale (ranging from 5-25). The scale has been used in several IBD studies and a global score > 20 indicates a good adherence.
Time Frame
through study completion, an average of 2 year
Title
Medical Adherence
Description
Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women. Further detail see outcome 1 and 2
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Assessment of disease activity by Mayo Score
Description
The Mayo Score is composed of 4 items. A score from 0-2 is categorised as remission and 11-12 as severe.
Time Frame
through study completion, an average of 2 year
Title
Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)
Description
The SCCAI rely solely on clinical assessments. Clinical remission are defined as SCCAI < 1 and clinical response as a change of at least 1 point.
Time Frame
through study completion, an average of 2 year
Title
Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Description
The UCEIS endoscopic severity on a scale of 1-4. Higher score mean worse disease severity.
Time Frame
through study completion, an average of 2 year
Title
Assessment of endoscopic severity by the Mayo endoscopic score
Description
The Mayo endoscopic score is scored on a scale of 0-3. Higher score mean worse disease severity.
Time Frame
through study completion, an average of 2 year
Title
Assessment of histological severity by the Geboes score
Description
The Geboes score is interpreted as such: a higher score means higher disease activity.
Time Frame
through study completion, an average of 2 year
Title
Assessment of histological severity by the Nancy Index
Description
The Nancy Index are interpreted as such: The grade 4 correspond to severe disease, grade 0 as " absence of significant histological disease".
Time Frame
through study completion, an average of 2 year
Title
Assessment of histological severity by the Robarts Histopathology Index (RHI)
Description
The RHI are interpreted as such: The score are ranging between 0 (no disease activity) to 33 (severe disease activity).
Time Frame
through study completion, an average of 2 year
Title
Correlation between the different clinical scores
Description
Comparison, correlation and association between the different endoscopic, histological and disease activity indices. Included will be: Mayo score, Simple clinical colitis activity index (SCCAI), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), Nancy Index, Robarts Histopathology Index (RHI) and the Geboes score (see outcome 4-10).
Time Frame
through study completion, an average of 2 year
Title
Remission - days
Description
Differences in number of days in remission during the trial
Time Frame
through study completion, an average of 2 year
Title
Relapse - days
Description
Differences in number of days in relapse during the trial
Time Frame
through study completion, an average of 2 year
Title
Remission and relapse - episodes
Description
Differences episodes of relapses during the trial
Time Frame
through study completion, an average of 2 year
Title
Changes in quality of life
Description
Prospective analyses of quality of life using 12-Item Short Form Survey (SF12). The SF12 is measured on a global score from 12-56. Beside a global score, a mental and physical dimension will also be calculated.
Time Frame
through study completion, an average of 2 year
Title
Changes in disease specific quality of life
Description
Prospective analyses quality of life using the Short inflammatory bowel disease questionnaire (SIBDQ) The SIBDQ is a quality of life (QOL) questionnaire ranging from 10-70. Higher score means better QOL.
Time Frame
through study completion, an average of 2 year
Title
Changes in disability among ulcerative colitis patients
Description
Prospective analyses of disability using the Inflammatory bowel disease disability index (IBD-DI) The IBD-DI measures the disability among patients with inflammatory bowel disease. Higher scores means worse disability.
Time Frame
through study completion, an average of 2 year
Title
Changes in sleep quality
Description
Prospective analyses of sleep using the Pittsburgh Sleep Quality Index (PSQI), The PSQI was designed to measure sleep quality and disturbance. A global score > 5 is considered poor sleep quality.
Time Frame
through study completion, an average of 2 year
Title
Changes in resilience
Description
Prospective analyses of resilience using the Brief Resilience Scale (BRS) The BRS is designed to measure the ability to bounce back or recover from stressful events. Higher scores means higher resilience.
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age between and including 18 and 60 Diagnosed with UC according to the Copenhagen Diagnostic Criteria Length of disease of max. 10 years Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion. Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2 Have had a relapse within the last 2 years Defined as the need of escalation of treatment or change medical treatment. Exclusion Criteria: Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month On immunomodulators, including methotrexate On any biological therapy Any previous abdominal surgery related to UC Any chronic infections (e.g. HBV, HCV, HIV) Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators. Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial. Any previous documented allergic reaction to tested the medical drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flemming Bendtsen, MDSci
Phone
+45 38623273
Email
Flemming.Bendtsen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Bobby Lo, MD
Email
bobby.lo@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Bendtsen, MDSci
Organizational Affiliation
Copenhagen University Hospital, Hvidovre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flemming Bendtsen
Email
Flemming.bendtsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Bobby Lo
Phone
+4528580410
Email
bobby.lo@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis

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