Clinical trial NCT04133194: Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
Official title: Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Medical Adherence
timeFrame: through study completion, an average of 2 year
measure: Medical Adherence
timeFrame: through study completion, an average of 2 year
measure: Medical Adherence
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Assessment of disease activity by Mayo Score
timeFrame: through study completion, an average of 2 year
measure: Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)
timeFrame: through study completion, an average of 2 year
measure: Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
timeFrame: through study completion, an average of 2 year
measure: Assessment of endoscopic severity by the Mayo endoscopic score
timeFrame: through study completion, an average of 2 year
measure: Assessment of histological severity by the Geboes score
timeFrame: through study completion, an average of 2 year
measure: Assessment of histological severity by the Nancy Index
timeFrame: through study completion, an average of 2 year
measure: Assessment of histological severity by the Robarts Histopathology Index (RHI)
timeFrame: through study completion, an average of 2 year
measure: Correlation between the different clinical scores
timeFrame: through study completion, an average of 2 year
measure: Remission - days
timeFrame: through study completion, an average of 2 year
measure: Relapse - days
timeFrame: through study completion, an average of 2 year
measure: Remission and relapse - episodes
timeFrame: through study completion, an average of 2 year
measure: Changes in quality of life
timeFrame: through study completion, an average of 2 year
measure: Changes in disease specific quality of life
timeFrame: through study completion, an average of 2 year
measure: Changes in disability among ulcerative colitis patients
timeFrame: through study completion, an average of 2 year
measure: Changes in sleep quality
timeFrame: through study completion, an average of 2 year
measure: Changes in resilience
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital Hvidovre
Study officials:
affiliation: Copenhagen University Hospital, Hvidovre
name: Flemming Bendtsen, MDSci
role: PRINCIPAL_INVESTIGATOR
References: