Mild-to-moderate Ulcerative Colitis Clinical Trial
— OPTIMISEOfficial title:
Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis
| Verified date | May 2024 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | October 20, 2023 |
| Est. primary completion date | October 20, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Vojenska nemocnice Brno p.o. | Brno | |
| Czechia | Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | |
| Czechia | EGK s.r.o. - Sanatorium sv. Anny | Praha | |
| Czechia | ISCARE IVF a.s. | Praha | |
| Czechia | Mediendo s.r.o. | Praha | |
| Czechia | KZ a.s. - Masaryk Hospital | Usti nad Labem | |
| Hungary | Pannonia Mgánorvosi Centrum Kft | Budapest | |
| Hungary | Semmelweis Egyetem, Isz. Sebeszeti es Intervencios Gasztroenterologiai Klinika | Budapest | |
| Hungary | Bugat Pal Hospital | Gyongyos | |
| Hungary | Bacs-Kiskun Megyei Oktatokorhaz | Kecskemet | |
| Hungary | University of Pecs | Pécs | |
| Hungary | Szegedi Tudomnyegyetem | Szeged | |
| Hungary | Javorszky Odon Hospital | Vac | |
| Italy | AOU Ospedali Riuniti di Ancona | Ancona | |
| Italy | ASST-FBF Luigi Sacco Hospital | Milan | |
| Italy | Ospedale San Raffaele S.R.L | Milano | |
| Italy | Ospedali Riuniti Villa Sofia-Cervello | Palermo | |
| Italy | Azienda Ospedaliero - Universitaria Pisana | Pisa | |
| Italy | A.O.Città della salute e della scienza diTorino | Torino | |
| Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
| Netherlands | Catharina Ziekenhuis | Eindhoven | |
| Netherlands | Franciscus Gasthuis & Vlietland | Rotterdam | |
| Poland | NZOZ Vitamed | Bydgoszcz | |
| Poland | Osrodek Sadan Klinicznych CLINSANTE | Bydgoszcz | |
| Poland | Szpital Uniwersytecki | 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 | Lódz | |
| Poland | Orodek Bada Klinicznych Allmedica | Nowy Targ | |
| Poland | Centrum Medyczne Medyk | Rzeszow | |
| Poland | Korczowski Bartosz, Gabinet Lekarski | Rzeszow | |
| Poland | H-T. Centrum Medyczne sp. z o.o. | Tychy | |
| Poland | Centralny Szpital Kliniczny Ministerstwa Spraw | Warszawa | |
| Poland | Centrum Diagnostyczno Lecznicze Barska | Wloclawek | |
| Poland | NZOZ Centrum Gastroenterologii w Wodzislawiu Slaskim | Wodzislaw Slaski | |
| Poland | Melita Medical | Wroclaw | |
| Poland | Clinhouse Centrum Medyczne | Zabrze | |
| Slovakia | ENDOMED s.r.o. | Kosice | |
| Slovakia | Pigeas s.r.o. | Martin | |
| Slovakia | Fakuktna Nemocnica Nitra | Nitra | |
| Slovakia | Gastro LM s.r.o. | Presov |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Czechia, Hungary, Italy, Netherlands, Poland, Slovakia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At 12 months | |
| Secondary | 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 | At 12 months | |
| Secondary | 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 | At 12 months | |
| Secondary | 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 | At 12 months | |
| Secondary | 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). | From Baseline over 12 Months | |
| Secondary | 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. | From Baseline over 12 Months | |
| Secondary | Percentage of Participants Escalated to Rescue Therapy | Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics. | Over 12 months | |
| Secondary | 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. | From Baseline over 12 Months | |
| Secondary | Number of Hospitalization Days | Number of hospitalization days will be determined by UC related medical resources. | Over 12 months | |
| Secondary | 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. | Over 12 months | |
| Secondary | 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. | Over 12 months | |
| Secondary | 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. | Over 12 months |