Study to Assess Effectiveness of Therapy Timely Adjustment Based on Self-monitoring in Patients Suffering From Mild-to-moderate Ulcerative Colitis (OPTIMISE Study)
- Conditions
- Mild-to-moderate Ulcerative Colitis
- Interventions
- Other: PRO-2 ScoringOther: Faecal Calprotectin Home Test
- Registration Number
- NCT04340895
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference arm PRO-2 Scoring 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 arm Faecal Calprotectin Home Test 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. Intervention arm PRO-2 Scoring 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Mayo Endoscopic Sub-score = 0 At 12 months 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
Name Time Method Percentage of Participants with Stool Frequency <=1 At 12 months 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
Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire From Baseline over 12 Months 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.
Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only) Over 12 months 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.
Percentage of Participants with Mayo Endoscopic Sub-score <=1 At 12 months 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
Percentage of Participants Escalated to Rescue Therapy Over 12 months Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics.
Number of Ulcerative Colitis Related Procedures and/or Surgeries Over 12 months Number of UC related procedures and/or surgeries will be determined by UC related medical resources.
Percentage of Participants with Rectal Bleeding = 0 At 12 months 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
Change in Short Form Questionnaire-36 (SF-36) From Baseline over 12 Months 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.
Number of Outpatients Visits and Calls (Outside of Study Schedule) Over 12 months Number of outpatients visits and calls (outside of study schedule) will be determined by UC related medical resources.
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) From Baseline over 12 Months 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).
Number of Hospitalization Days Over 12 months Number of hospitalization days will be determined by UC related medical resources.
Trial Locations
- Locations (42)
Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Italy
University of Pecs
🇭🇺Pécs, Hungary
EGK s.r.o. - Sanatorium sv. Anny
🇨🇿Praha, Czechia
Vojenska nemocnice Brno p.o.
🇨🇿Brno, Czechia
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Králové, Czechia
Mediendo s.r.o.
🇨🇿Praha, Czechia
ISCARE IVF a.s.
🇨🇿Praha, Czechia
Bugat Pal Hospital
🇭🇺Gyongyos, Hungary
Javorszky Odon Hospital
🇭🇺Vac, Hungary
Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika
🇭🇺Budapest, Hungary
Pannonia Mgánorvosi Centrum Kft
🇭🇺Budapest, Hungary
Bacs-Kiskun Megyei Oktatokorhaz
🇭🇺Kecskemet, Hungary
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Netherlands
Szegedi Tudomnyegyetem
🇭🇺Szeged, Hungary
KZ a.s. - Masaryk Hospital
🇨🇿Usti nad Labem, Czechia
AOU Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Ospedale San Raffaele S.R.L
🇮🇹Milano, Italy
ASST-FBF Luigi Sacco Hospital
🇮🇹Milan, Italy
Azienda Ospedaliero - Universitaria Pisana
🇮🇹Pisa, Italy
A.O.Città della salute e della scienza diTorino
🇮🇹Torino, Italy
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 Medyk
🇵🇱Rzeszow, Poland
Centrum Medyczne Promed
🇵🇱Krakow, Poland
Orodek Bada Klinicznych Allmedica
🇵🇱Nowy Targ, Poland
H-T. Centrum Medyczne sp. z o.o.
🇵🇱Tychy, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszow, Poland
Melita Medical
🇵🇱Wrocław, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw
🇵🇱Warszawa, Poland
Centrum Diagnostyczno Lecznicze Barska
🇵🇱Wloclawek, Poland
NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim
🇵🇱Wodzislaw Slaski, Poland
Clinhouse Centrum Medyczne
🇵🇱Zabrze, Poland
ENDOMED s.r.o.
🇸🇰Kosice, Slovakia
Gastro LM s.r.o.
🇸🇰Presov, Slovakia
SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
🇵🇱Łódź, Poland
Pigeas s.r.o.
🇸🇰Martin, Slovakia
Fakuktna Nemocnica Nitra
🇸🇰Nitra, Slovakia