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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04340895
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ferring Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Global Clinical Compliance
Principal Investigator Affiliation Ferring Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Czechia, Netherlands, Poland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Mild-to-moderate Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Intervention arm

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.

Active Comparator: Reference arm

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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vojenska nemocnice Brno p.o., Brno, Czechia

Status

Recruiting

Address

Vojenska nemocnice Brno p.o.

Brno, ,

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

Status

Recruiting

Address

Hepato-Gastroenterologie HK, s.r.o.

Hradec Králové, ,

EGK s.r.o. - Sanatorium sv. Anny, Praha, Czechia

Status

Recruiting

Address

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

Praha, ,

ISCARE IVF a.s., Praha, Czechia

Status

Recruiting

Address

ISCARE IVF a.s.

Praha, ,

Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands

Status

Recruiting

Address

Jeroen Bosch Ziekenhuis

Den Bosch, ,

Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands

Status

Recruiting

Address

Franciscus Gasthuis & Vlietland

Rotterdam, ,

Centrum Medyczne LukaMed, Chojnice, Poland

Status

Recruiting

Address

Centrum Medyczne LukaMed

Chojnice, ,

Jelenia Góra, Poland

Status

Recruiting

Address

Karkonoskie Centrum Bada Klinicznych - Lexmedica SP Z O O

Jelenia Góra, ,

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

Status

Recruiting

Address

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

Tychy, ,

Centrum Diagnostyczno Lecznicze Barska, Wloclawek, Poland

Status

Recruiting

Address

Centrum Diagnostyczno Lecznicze Barska

Wloclawek, ,

Melita Medical, Wrocław, Poland

Status

Recruiting

Address

Melita Medical

Wrocław, ,

Łódź, Poland

Status

Recruiting

Address

SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia

Łódź, ,

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