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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
1600 mg Asacol \[mesalazine\]
800 mg Asacol \[mesalazine\]
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark
RECRUITINGMedical Adherence
Measured by drug accountability log Patients having taken ≥80 % are categorised as adherent
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
Assessment of histological severity by the Geboes score
The Geboes score is interpreted as such: a higher score means higher disease activity.
Time frame: through study completion, an average of 2 year
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".
Time frame: through study completion, an average of 2 year
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).
Time frame: through study completion, an average of 2 year
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).
Time frame: through study completion, an average of 2 year
Remission - days
Differences in number of days in remission during the trial
Time frame: through study completion, an average of 2 year
Relapse - days
Differences in number of days in relapse during the trial
Time frame: through study completion, an average of 2 year
Remission and relapse - episodes
Differences episodes of relapses during the trial
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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.
Time frame: through study completion, an average of 2 year
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