Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
- Registration Number
- NCT04133194
- Lead Sponsor
- Flemming Bendtsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
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Signed informed consent
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Age between and including 18 and 60
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Diagnosed with UC according to the Copenhagen Diagnostic Criteria
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Length of disease of max. 10 years
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Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
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Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2
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Have had a relapse within the last 2 years
- Defined as the need of escalation of treatment or change medical treatment.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1600 mg Asacol (mesalazine) Mesalazine 1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year 800 mg Asacol (mesalazine) Mesalazine 800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year
- Primary Outcome Measures
Name Time Method Medical Adherence through study completion, an average of 2 year 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
Name Time Method Remission - days through study completion, an average of 2 year Differences in number of days in remission during the trial
Assessment of disease activity by the Simple clinical colitis activity index (SCCAI) through study completion, an average of 2 year 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 Mayo endoscopic score through study completion, an average of 2 year 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 through study completion, an average of 2 year The Geboes score is interpreted as such: a higher score means higher disease activity.
Changes in disease specific quality of life through study completion, an average of 2 year 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 through study completion, an average of 2 year 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.Assessment of disease activity by Mayo Score through study completion, an average of 2 year The Mayo Score is composed of 4 items. A score from 0-2 is categorised as remission and 11-12 as severe.
Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) through study completion, an average of 2 year The UCEIS endoscopic severity on a scale of 1-4. Higher score mean worse disease severity.
Assessment of histological severity by the Nancy Index through study completion, an average of 2 year 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) through study completion, an average of 2 year 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 through study completion, an average of 2 year 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).Relapse - days through study completion, an average of 2 year Differences in number of days in relapse during the trial
Changes in resilience through study completion, an average of 2 year 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.Remission and relapse - episodes through study completion, an average of 2 year Differences episodes of relapses during the trial
Changes in quality of life through study completion, an average of 2 year 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 sleep quality through study completion, an average of 2 year 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.
Trial Locations
- Locations (1)
Copenhagen University Hospital Hvidovre
🇩🇰Hvidovre, Denmark