Status:
COMPLETED
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Mild-to-moderate Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to provide evidence that a therapy of Ulcerative Colitis (UC) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprot...
Eligibility Criteria
Inclusion
- Adult Participants (≥ 18 years old)
- Participants with active mild-to-moderate UC (with RB and bowel inflammation confirmed by endoscopy)
- Participants with treatment with 5-aminosalicylic acid (5-ASA) ≤ 2.4 g/day or with no treatment regimen at Baseline
- Participants who agree to use FC home test (to dose FC in faeces as a marker of inflammation)
- Participants with internet access and smartphone with camera
Exclusion
- Participants currently enrolled in another interventional study
- Participants not willing to undergo an endoscopy at the end of study
- Participants with contraindications to treatment with 5-ASA and/or 2nd generation corticosteroids
- Participants not willing to perform FC self-testing in faeces at home
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04340895
Start Date
October 14 2019
End Date
October 20 2023
Last Update
September 19 2024
Active Locations (42)
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1
Vojenska nemocnice Brno p.o.
Brno, Czechia, 63600
2
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia, 50012
3
EGK s.r.o. - Sanatorium sv. Anny
Prague, Czechia, 13000
4
ISCARE IVF a.s.
Prague, Czechia, 17000