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

NACompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 14, 2019

Primary Completion Date

October 20, 2023

Study Completion Date

October 20, 2023

Conditions
Mild-to-moderate Ulcerative Colitis
Interventions
OTHER

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."

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.

Trial Locations (42)

1088

Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika, Budapest

1136

Pannonia Mgánorvosi Centrum Kft, Budapest

2600

Javorszky Odon Hospital, Vác

3200

Bugat Pal Hospital, Gyöngyös

4013

ENDOMED s.r.o., Košice

6000

Bacs-Kiskun Megyei Oktatokorhaz, Kecskemét

6725

Szegedi Tudomnyegyetem, Szeged

7624

University of Pecs, Pécs

8001

Gastro LM s.r.o., Prešov

10126

A.O.Città della salute e della scienza diTorino, Torino

13000

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

17000

ISCARE IVF a.s., Prague

18600

Mediendo s.r.o., Prague

20132

Ospedale San Raffaele S.R.L, Milan

20157

ASST-FBF Luigi Sacco Hospital, Milan

40113

KZ a.s. - Masaryk Hospital, Ústí nad Labem

50012

Hepato-Gastroenterologie HK, s.r.o., Hradec Králové

56124

Azienda Ospedaliero - Universitaria Pisana, Pisa

60126

AOU Ospedali Riuniti di Ancona, Ancona

63600

Vojenska nemocnice Brno p.o., Brno

85168

Szpital Uniwersytecki, Bydgoszcz

90146

Ospedali Riuniti Villa Sofia-Cervello, Palermo

90302

SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia, Lodz

94901

Fakuktna Nemocnica Nitra, Nitra

5223GZ

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

5623EJ

Catharina Ziekenhuis, Eindhoven

3045 BM

Franciscus Gasthuis & Vlietland, Rotterdam

85-079

NZOZ Vitamed, Bydgoszcz

Unknown

Osrodek Sadan Klinicznych CLINSANTE, Bydgoszcz

89-600

Centrum Medyczne LukaMed, Chojnice

58-500

Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O, Jelenia Góra

31-513

Centrum Medyczne Promed, Krakow

34-400

Orodek Bada Klinicznych Allmedica, Nowy Targ

35-236

Centrum Medyczne Medyk, Rzeszów

35-302

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

43-110

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

02-507

Centralny Szpital Kliniczny Ministerstwa Spraw, Warsaw

44-300

NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim, Wodzisław Śląski

50-529

Melita Medical, Wroclaw

87-806

Centrum Diagnostyczno Lecznicze Barska, Włocławek

41-807

Clinhouse Centrum Medyczne, Zabrze

03601

Pigeas s.r.o., Martin

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT04340895 - Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study) | Biotech Hunter | Biotech Hunter