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

NCT ID: NCT04340895

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2023-10-20

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 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.

Conditions

Mild-to-moderate Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention arm

Treatment optimization (escalation/de-escalation) performed by the investigator based on participant self-monitoring of FC values and/or clinical symptoms (patient-reported outcome-2 [PRO-2] scoring).

The FC Test and/or PRO-2 scoring will be done by the participant at home every month during active disease, every 3 months in remission, or when a participant feels the need/presents clinical symptoms.

Group Type: EXPERIMENTAL

Faecal Calprotectin Home Test

Intervention Type: OTHER

A non-invasive, in vitro diagnostic test for the determination of FC levels in human stool samples in combination with the dedicated 'CalproSmart' smartphone application.

This test helps participants to self-monitor their FC levels at their own homes, ensuring an adequate and effective medical treatment regimen performed by the investigator.

PRO-2 Scoring

Intervention Type: OTHER

Monitoring of clinical symptoms will be performed by PRO-2 scoring, which includes rectal bleeding (RB) and stool frequency (SF) assessment obtained within the last 3-days.

Reference arm

Treatment optimization (escalation/de-escalation) performed by the investigator based on clinical symptoms (PRO-2 scoring) only.

The PRO-2 scoring will be assessed during clinic visits every 3-months during active disease, every 6 months during remission, or when a participant feels the need; as per recommended standard practice.

Group Type: ACTIVE_COMPARATOR

PRO-2 Scoring

Intervention Type: OTHER

Monitoring of clinical symptoms will be performed by PRO-2 scoring, which includes rectal bleeding (RB) and stool frequency (SF) assessment obtained within the last 3-days.

Interventions

Faecal Calprotectin Home Test

A non-invasive, in vitro diagnostic test for the determination of FC levels in human stool samples in combination with the dedicated 'CalproSmart' smartphone application.

This test helps participants to self-monitor their FC levels at their own homes, ensuring an adequate and effective medical treatment regimen performed by the investigator.

Intervention Type: OTHER

PRO-2 Scoring

Monitoring of clinical symptoms will be performed by PRO-2 scoring, which includes rectal bleeding (RB) and stool frequency (SF) assessment obtained within the last 3-days.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Vojenska nemocnice Brno p.o.

Brno, , Czechia

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, , Czechia

EGK s.r.o. - Sanatorium sv. Anny

Prague, , Czechia

ISCARE IVF a.s.

Prague, , Czechia

Mediendo s.r.o.

Prague, , Czechia

KZ a.s. - Masaryk Hospital

Ústí nad Labem, , Czechia

Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika

Budapest, , Hungary

Pannonia Mgánorvosi Centrum Kft

Budapest, , Hungary

Bugat Pal Hospital

Gyöngyös, , Hungary

Bacs-Kiskun Megyei Oktatokorhaz

Kecskemét, , Hungary

University of Pecs

Pécs, , Hungary

Szegedi Tudomnyegyetem

Szeged, , Hungary

Javorszky Odon Hospital

Vác, , Hungary

AOU Ospedali Riuniti di Ancona

Ancona, , Italy

ASST-FBF Luigi Sacco Hospital

Milan, , Italy

Ospedale San Raffaele S.R.L

Milan, , Italy

Ospedali Riuniti Villa Sofia-Cervello

Palermo, , Italy

Azienda Ospedaliero - Universitaria Pisana

Pisa, , Italy

A.O.Città della salute e della scienza diTorino

Torino, , Italy

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Franciscus Gasthuis & Vlietland

Rotterdam, , Netherlands

NZOZ Vitamed

Bydgoszcz, , Poland

Szpital Uniwersytecki

Bydgoszcz, , Poland

Osrodek Sadan Klinicznych CLINSANTE

Bydgoszcz, , Poland

Centrum Medyczne LukaMed

Chojnice, , Poland

Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O

Jelenia Góra, , Poland

Centrum Medyczne Promed

Krakow, , Poland

SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia

Lodz, , Poland

Orodek Bada Klinicznych Allmedica

Nowy Targ, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

H-T. Centrum Medyczne sp. z o.o.

Tychy, , Poland

Centralny Szpital Kliniczny Ministerstwa Spraw

Warsaw, , Poland

NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim

Wodzisław Śląski, , Poland

Melita Medical

Wroclaw, , Poland

Centrum Diagnostyczno Lecznicze Barska

Włocławek, , Poland

Clinhouse Centrum Medyczne

Zabrze, , Poland

ENDOMED s.r.o.

Košice, , Slovakia

Pigeas s.r.o.

Martin, , Slovakia

Fakuktna Nemocnica Nitra

Nitra, , Slovakia

Gastro LM s.r.o.

Prešov, , Slovakia

Countries

Czechia; Hungary; Italy; Netherlands; Poland; Slovakia

References

Danese S, Fiorino G, Vicaut E, Paridaens K, Ugur A, Clark B, Vanasek T, Stepek D, D'Amico F, West R, Gilissen LPL, Wisniewska Jarosinka M, Drobinski P, Fronik G, Fic M, Walczak M, Kowalski M, Korczowski B, Wiatr M, Peyrin-Biroulet L. 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. J Clin Med. 2024 Aug 30;13(17):5147. doi: 10.3390/jcm13175147.

Reference Type: RESULT

PMID: 39274360 (View on PubMed)

Dal Buono A, Roda G, Argollo M, Paridaens K, Peyrin-Biroulet L, Danese S. 'Treat to Target' in Mild to Moderate Ulcerative Colitis: Evidence to Support this Strategy. Curr Drug Targets. 2021;22(1):117-125. doi: 10.2174/1389450121666200727120305.

Reference Type: DERIVED

PMID: 32718289 (View on PubMed)

Other Identifiers

7002661

Identifier Type: -

Identifier Source: org_study_id