E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis (UC) causes long-lasting inflammation and sores in your digestive tract. UC affects large intestine. UC can sometimes lead to life-threatening complications. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 2 • Have had a relapse within the last 2 years |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is drug accountability ≥80 %. Patients having taken ≥80 % are categorised as adherent. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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If serious safety concerns arise, the primary investigator can terminate or interrupt the study. If new scientific information becomes available during the study on the desired outcomes with no difference to the study, the principal investigator reserves the right to interrupt or terminate the study. Premature termination is also possible if the principal investigator notice and agree upon that patient recruitment is insufficient and that this cannot be expedited by appropriate measures. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |