Clinical trial NCT04340895: Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
Official title: Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild-to-moderate Ulcerative Colitis
Keywords: Ulcerative Colitis
Management strategies
Pragmatic trial
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-04-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percentage of Participants with Mayo Endoscopic Sub-score = 0
timeFrame: At 12 months
Secondary outcomes:
measure: Percentage of Participants with Rectal Bleeding = 0
timeFrame: At 12 months
measure: Percentage of Participants with Stool Frequency <=1
timeFrame: At 12 months
measure: Percentage of Participants with Mayo Endoscopic Sub-score <=1
timeFrame: At 12 months
measure: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
timeFrame: From Baseline over 12 Months
measure: Change in Short Form Questionnaire-36 (SF-36)
timeFrame: From Baseline over 12 Months
measure: Percentage of Participants Escalated to Rescue Therapy
timeFrame: Over 12 months
measure: Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire
timeFrame: From Baseline over 12 Months
measure: Number of Hospitalization Days
timeFrame: Over 12 months
measure: Number of Outpatients Visits and Calls (Outside of Study Schedule)
timeFrame: Over 12 months
measure: Number of Ulcerative Colitis Related Procedures and/or Surgeries
timeFrame: Over 12 months
measure: Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only)
timeFrame: Over 12 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Vojenska nemocnice Brno p.o.
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Praha
country: Czechia
facility: EGK s.r.o. - Sanatorium sv. Anny
city: Praha
country: Czechia
facility: ISCARE IVF a.s.
city: Praha
country: Czechia
facility: Mediendo s.r.o.
city: Usti nad Labem
country: Czechia
facility: KZ a.s. - Masaryk Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika
city: Budapest
country: Hungary
facility: Pannonia Mgánorvosi Centrum Kft
city: Gyongyos
country: Hungary
facility: Bugat Pal Hospital
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Oktatokorhaz
city: Pécs
country: Hungary
facility: University of Pecs
city: Szeged
country: Hungary
facility: Szegedi Tudomnyegyetem
city: Vac
country: Hungary
facility: Javorszky Odon Hospital
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti di Ancona
city: Milano
country: Italy
facility: Ospedale San Raffaele S.R.L
city: Milan
country: Italy
facility: ASST-FBF Luigi Sacco Hospital
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia-Cervello
city: Pisa
country: Italy
facility: Azienda Ospedaliero - Universitaria Pisana
city: Torino
country: Italy
facility: A.O.Città della salute e della scienza diTorino
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki
city: Bydgoszcz
country: Poland
facility: Osrodek Sadan Klinicznych CLINSANTE
city: Chojnice
country: Poland
facility: Centrum Medyczne LukaMed
city: Jelenia Góra
country: Poland
facility: Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O
city: Krakow
country: Poland
facility: Centrum Medyczne Promed
city: Nowy Targ
country: Poland
facility: Orodek Bada Klinicznych Allmedica
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Tychy
country: Poland
facility: H-T. Centrum Medyczne sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno Lecznicze Barska
city: Wodzislaw Slaski
country: Poland
facility: NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim
city: Wrocław
country: Poland
facility: Melita Medical
city: Zabrze
country: Poland
facility: Clinhouse Centrum Medyczne
city: Łódź
country: Poland
facility: SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
city: Kosice
country: Slovakia
facility: ENDOMED s.r.o.
city: Martin
country: Slovakia
facility: Pigeas s.r.o.
city: Nitra
country: Slovakia
facility: Fakuktna Nemocnica Nitra
city: Presov
country: Slovakia
facility: Gastro LM s.r.o.
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.