NCT04340895: OPTIMISE

Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Faecal Calprotectin Home Test in Mild-to-moderate Ulcerative Colitis in 250 participants. Completed in 20 October 2023.

Timeline

14 October 2019

Primary endpoint
20 October 2023

20 October 2023

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	250
Start date	14 October 2019
Primary completion	20 October 2023
Estimated completion	20 October 2023
Sites	42 locations across Italy, Netherlands, Slovakia, Poland, Hungary, Czechia

Drugs / interventions tested

• Faecal Calprotectin Home Test
• PRO-2 Scoring

Conditions studied

• Mild-to-moderate Ulcerative Colitis — all drugs for Mild-to-moderate Ulcerative Colitis →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Mild-to-moderate Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical Trial: A Pragmatic Randomised Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis-The OPTIMISE Study.
   Danese S, Fiorino G, Vicaut E, Paridaens K, et al · · 2024 · cited 4× · PMID 39274360 · DOI 10.3390/jcm13175147
2. iSTART-II: An Update on the i Support Therapy-Access to Rapid Treatment (iSTART) Approach for Patient-Centered Therapy in Mild-to-Moderate Ulcerative Colitis.
   D'Amico F, Magro F, Caron B, Dignass A, et al · · 2023 · cited 3× · PMID 36769791 · DOI 10.3390/jcm12031142
3. Drug Optimization in Patients with Mild-to-Moderate Ulcerative Colitis: A Global Survey.
   D'Amico F, Jairath V, Paridaens K, Peyrin-Biroulet L, et al · · 2024 · cited 2× · PMID 38731039 · DOI 10.3390/jcm13092510