Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.
Conditions
Interventions
Trade Name: Asacol®
Pharmaceutical Form: Tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89-57-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1600-4800
Sponsors
Copenhagen University Hospital Hvidovre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent • Age between 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. • Endoscopic remission defined as Mayo Clinic Endoscopic Score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether a simplified treatment regimen for Mesalazine (5- ASA) (1600 mg as one tablet per day [intervention]) improves adherence compared to conventional therapy. ;Secondary Objective: •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. •Compare levels of endoscopic, mucosal and histological inflammation between the intervention group and the conventional therapy group. •Investigate whether a simplified treatment regimen improves the disease course (defined by number of days of remission and number of flare) compared to the conventional therapy. •To assess the correlation of mucosal healing and the disease courses (defined by number of days of remission and number of flare), with the 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 UC for identification of future biomarkers. ;Primary end point(s): The primary outcome measure is drug accountability =80 %. Patients having taken =80 % are categorised as adherent. ;Timepoint(s) of evaluation of this end point: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of days of remission and number of flare Disease activity Endoscopic and histological index scores Patient reported outcomes index scores Microbiom profiling ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Denmark
Contacts
Public ContactThe Gastro Unit, medical section
Copenhagen University Hospital Hvidovre
Outcome results
None listed