Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis (OPTIMISE)

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    240
  • sponsor
    Ferring Pharmaceuticals
Updated on 24 October 2022

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 calprotectin (FC) (substance that is released when intestines are inflamed and that can be measured in faeces), can provide significantly higher benefit for the participants in terms of disease control and quality of life (QoL) improvement, compared to a symptom-based approach only.

Details
Condition Mild-to-moderate Ulcerative Colitis
Treatment Faecal Calprotectin Home Test, PRO-2 Scoring
Clinical Study IdentifierNCT04340895
SponsorFerring Pharmaceuticals
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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