Back to resultsStudy to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study) (OPTIMISE)
Primary Purpose
Mild-to-moderate Ulcerative Colitis
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Faecal Calprotectin Home Test
PRO-2 Scoring
Sponsored by
About this trial
This is an interventional other trial for Mild-to-moderate Ulcerative Colitis focused on measuring Ulcerative Colitis, Management strategies, Pragmatic trial
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
Sites / Locations
- Vojenska nemocnice Brno p.o.
- Hepato-Gastroenterologie HK, s.r.o.
- EGK s.r.o. - Sanatorium sv. Anny
- ISCARE IVF a.s.
- Mediendo s.r.o.
- KZ a.s. - Masaryk Hospital
- Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika
- Pannonia Mgánorvosi Centrum Kft
- Bugat Pal Hospital
- Bacs-Kiskun Megyei Oktatokorhaz
- University of Pecs
- Szegedi Tudomnyegyetem
- Javorszky Odon Hospital
- AOU Ospedali Riuniti di Ancona
- Ospedale San Raffaele S.R.L
- ASST-FBF Luigi Sacco Hospital
- Ospedali Riuniti Villa Sofia-Cervello
- Azienda Ospedaliero - Universitaria Pisana
- A.O.Città della salute e della scienza diTorino
- Jeroen Bosch Ziekenhuis
- Catharina Ziekenhuis
- Franciscus Gasthuis & Vlietland
- NZOZ Vitamed
- Szpital Uniwersytecki
- Osrodek Sadan Klinicznych CLINSANTE
- Centrum Medyczne LukaMed
- Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O
- Centrum Medyczne Promed
- Orodek Bada Klinicznych Allmedica
- Centrum Medyczne Medyk
- Korczowski Bartosz, Gabinet Lekarski
- H-T. Centrum Medyczne sp. z o.o.
- Centralny Szpital Kliniczny Ministerstwa Spraw
- Centrum Diagnostyczno Lecznicze Barska
- NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim
- Melita Medical
- Clinhouse Centrum Medyczne
- SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
- ENDOMED s.r.o.
- Pigeas s.r.o.
- Fakuktna Nemocnica Nitra
- Gastro LM s.r.o.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Reference arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants with Mayo Endoscopic Sub-score = 0
Defined as the percentage of participants achieved mucosal healing (Mayo endoscopic sub-score of 0 [normal friability]). The Mayo endoscopic scoring ranges from 0-3 with higher scores indicating greater disease severity. The score is defined as 0-3: 0= Normal; 1=Mild friability; 2 = Moderate friability; 3 = Exudation, spontaneous hemorrhage.
Secondary Outcome Measures
Percentage of Participants with Rectal Bleeding = 0
Defined as the percentage of participants with no RB (RB=0). The RB score ranges from 0-3 with higher scores indicating greater disease severity. The score was defined as 0-3: 0 = None; 1 = Streak of blood; 2 = Obvious blood; 3 = Mostly blood
Percentage of Participants with Stool Frequency <=1
Defined as the percentage of participants with SF<=1. The SF score ranges from 0-3 with higher scores indicating greater disease severity. The score was defined as 0-3: 0 = None; 1 = 1-2 stools/day > normal; 2 = 3-4 stools/day > normal; 3 = >4 stools/day > normal
Percentage of Participants with Mayo Endoscopic Sub-score <=1
Defined as the percentage of participants achieved endoscopic remission (Mayo endoscopic sub-score <=1 [normal or mild friability]). The Mayo endoscopic scoring ranges from 0-3 with higher scores indicating greater disease severity. The sub-score was defined as 0-3: 0 = Normal friability; 1 = Mild friability; 2 = Moderate friability; 3 = Exudation, spontaneous hemorrhage
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Defined as a change in the QoL using SIBDQ over 12 months. The SIBDQ consists of 10 questions, measuring systemic, social, Bowel, and emotional status; each question is scored on a scale from 1 (poor QoL) to 7 (optimum QoL). A higher score indicates a better QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
Change in Short Form Questionnaire-36 (SF-36)
The SF-36 is a health-related survey that assesses participant's QoL and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental component score and physical component score). Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Percentage of Participants Escalated to Rescue Therapy
Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics.
Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire
The WPAI-UC is a questionnaire with 6 questions used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages.
Number of Hospitalization Days
Number of hospitalization days will be determined by UC related medical resources.
Number of Outpatients Visits and Calls (Outside of Study Schedule)
Number of outpatients visits and calls (outside of study schedule) will be determined by UC related medical resources.
Number of Ulcerative Colitis Related Procedures and/or Surgeries
Number of UC related procedures and/or surgeries will be determined by UC related medical resources.
Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only)
The FC Test will be done by the participant at home every month during active disease, every 3 months in remission, or when participant feels the need/presents clinical symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04340895
Brief Title
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
Acronym
OPTIMISE
Official Title
Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-to-moderate Ulcerative Colitis
Keywords
Ulcerative Colitis, Management strategies, Pragmatic trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Reference arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Faecal Calprotectin Home Test
Intervention Description
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
Intervention Name(s)
PRO-2 Scoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants with Mayo Endoscopic Sub-score = 0
Description
Defined as the percentage of participants achieved mucosal healing (Mayo endoscopic sub-score of 0 [normal friability]). The Mayo endoscopic scoring ranges from 0-3 with higher scores indicating greater disease severity. The score is defined as 0-3: 0= Normal; 1=Mild friability; 2 = Moderate friability; 3 = Exudation, spontaneous hemorrhage.
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants with Rectal Bleeding = 0
Description
Defined as the percentage of participants with no RB (RB=0). The RB score ranges from 0-3 with higher scores indicating greater disease severity. The score was defined as 0-3: 0 = None; 1 = Streak of blood; 2 = Obvious blood; 3 = Mostly blood
Time Frame
At 12 months
Title
Percentage of Participants with Stool Frequency <=1
Description
Defined as the percentage of participants with SF<=1. The SF score ranges from 0-3 with higher scores indicating greater disease severity. The score was defined as 0-3: 0 = None; 1 = 1-2 stools/day > normal; 2 = 3-4 stools/day > normal; 3 = >4 stools/day > normal
Time Frame
At 12 months
Title
Percentage of Participants with Mayo Endoscopic Sub-score <=1
Description
Defined as the percentage of participants achieved endoscopic remission (Mayo endoscopic sub-score <=1 [normal or mild friability]). The Mayo endoscopic scoring ranges from 0-3 with higher scores indicating greater disease severity. The sub-score was defined as 0-3: 0 = Normal friability; 1 = Mild friability; 2 = Moderate friability; 3 = Exudation, spontaneous hemorrhage
Time Frame
At 12 months
Title
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Description
Defined as a change in the QoL using SIBDQ over 12 months. The SIBDQ consists of 10 questions, measuring systemic, social, Bowel, and emotional status; each question is scored on a scale from 1 (poor QoL) to 7 (optimum QoL). A higher score indicates a better QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).
Time Frame
From Baseline over 12 Months
Title
Change in Short Form Questionnaire-36 (SF-36)
Description
The SF-36 is a health-related survey that assesses participant's QoL and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental component score and physical component score). Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
Time Frame
From Baseline over 12 Months
Title
Percentage of Participants Escalated to Rescue Therapy
Description
Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics.
Time Frame
Over 12 months
Title
Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire
Description
The WPAI-UC is a questionnaire with 6 questions used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages.
Time Frame
From Baseline over 12 Months
Title
Number of Hospitalization Days
Description
Number of hospitalization days will be determined by UC related medical resources.
Time Frame
Over 12 months
Title
Number of Outpatients Visits and Calls (Outside of Study Schedule)
Description
Number of outpatients visits and calls (outside of study schedule) will be determined by UC related medical resources.
Time Frame
Over 12 months
Title
Number of Ulcerative Colitis Related Procedures and/or Surgeries
Description
Number of UC related procedures and/or surgeries will be determined by UC related medical resources.
Time Frame
Over 12 months
Title
Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only)
Description
The FC Test will be done by the participant at home every month during active disease, every 3 months in remission, or when participant feels the need/presents clinical symptoms.
Time Frame
Over 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vojenska nemocnice Brno p.o.
City
Brno
ZIP/Postal Code
63600
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Králové
ZIP/Postal Code
50012
Country
Czechia
Facility Name
EGK s.r.o. - Sanatorium sv. Anny
City
Praha
ZIP/Postal Code
13000
Country
Czechia
Facility Name
ISCARE IVF a.s.
City
Praha
ZIP/Postal Code
17000
Country
Czechia
Facility Name
Mediendo s.r.o.
City
Praha
ZIP/Postal Code
18600
Country
Czechia
Facility Name
KZ a.s. - Masaryk Hospital
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Pannonia Mgánorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Bugat Pal Hospital
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Oktatokorhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
University of Pecs
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomnyegyetem
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Javorszky Odon Hospital
City
Vac
ZIP/Postal Code
2600
Country
Hungary
Facility Name
AOU Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedale San Raffaele S.R.L
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST-FBF Luigi Sacco Hospital
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedali Riuniti Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
A.O.Città della salute e della scienza diTorino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
ZIP/Postal Code
5223GZ
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623EJ
Country
Netherlands
Facility Name
Franciscus Gasthuis & Vlietland
City
Rotterdam
ZIP/Postal Code
3045 BM
Country
Netherlands
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Szpital Uniwersytecki
City
Bydgoszcz
ZIP/Postal Code
85168
Country
Poland
Facility Name
Osrodek Sadan Klinicznych CLINSANTE
City
Bydgoszcz
Country
Poland
Facility Name
Centrum Medyczne LukaMed
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O
City
Jelenia Góra
ZIP/Postal Code
58-500
Country
Poland
Facility Name
Centrum Medyczne Promed
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Facility Name
Orodek Bada Klinicznych Allmedica
City
Nowy Targ
ZIP/Postal Code
34-400
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
ZIP/Postal Code
35-236
Country
Poland
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Name
H-T. Centrum Medyczne sp. z o.o.
City
Tychy
ZIP/Postal Code
43-110
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Diagnostyczno Lecznicze Barska
City
Wloclawek
ZIP/Postal Code
87-806
Country
Poland
Facility Name
NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim
City
Wodzislaw Slaski
ZIP/Postal Code
44-300
Country
Poland
Facility Name
Melita Medical
City
Wrocław
ZIP/Postal Code
50-529
Country
Poland
Facility Name
Clinhouse Centrum Medyczne
City
Zabrze
ZIP/Postal Code
41-807
Country
Poland
Facility Name
SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
City
Łódź
ZIP/Postal Code
90302
Country
Poland
Facility Name
ENDOMED s.r.o.
City
Kosice
ZIP/Postal Code
4013
Country
Slovakia
Facility Name
Pigeas s.r.o.
City
Martin
ZIP/Postal Code
03601
Country
Slovakia
Facility Name
Fakuktna Nemocnica Nitra
City
Nitra
ZIP/Postal Code
94901
Country
Slovakia
Facility Name
Gastro LM s.r.o.
City
Presov
ZIP/Postal Code
8001
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32718289
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.
Results Reference
derived
Learn more about this trial
Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
We'll reach out to this number within 24 hrs