Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ipsen
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or Female patient ≥ 18 years old and ≤ 65 years old
Patient has provided written informed consent to participate in the study after the purpose and nature have been clearly explained to him/her;
Patient with documented diagnosis of mild-moderate Ulcerative Colitis (UC). The "documented diagnosis" should include a typical histology observed at least once in the course of the disease;
Have a documented history of UC that has been successfully maintained in complete steroid-free remission for at least 1 month prior to study entry;
The modified mayo score ≤ 2, without subscore \>1, which is supported by a rectum-sigmoidoscopy or a colonoscopy;
Regimen of maintenance of remission contains Etiasa®
Patient mentally and physically able to answer the questionnaire.
You may not be if
Have a history of allergy or hypersensitivity to salicylates, 5-aminosalicylates, or any component of Etiasa®;
Pregnant and breastfeeding women, approaching childbirth female or unwilling to take birth control measures during the study;
A topical 5-aminosalicylate agent is included in the regimen;
Patients with infectious colitis (positive for germs, ovum or parasites causing bowel disease);
Treated with the other study drug at enrollment, or within past 3 months of enrollment;
Serious underlying disease other than UC which in the opinion of the investigator may interfere with the patient's ability to participate fully in the study;
Crohn's disease;
Pancreatitis;
Known bleeding disorders;
Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Clareo Health | Study of the Effectiveness of ETIASA® (Sustained Release 5-Aminosalicylate) in Maintenance Treatment of Ulcerative Colitis (UC)
