Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI)

Flemming Bendtsen

Status and phase: Enrolling; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: Mesalazine

Study type: Interventional

Funder types: Other

Identifiers

NCT04133194

1337-EASI-trial

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1600 mg Asacol (mesalazine)

Experimental group

Description:

1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year

Treatment:

Drug: Mesalazine

Drug: Mesalazine

800 mg Asacol (mesalazine)

Active Comparator group

Description:

800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year

Treatment:

Drug: Mesalazine

Drug: Mesalazine