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

Ferring

Status: Completed

Conditions: Mild-to-moderate Ulcerative Colitis

Treatments: Other: Faecal Calprotectin Home Test; Other: PRO-2 Scoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT04340895

7002661

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Intervention arm

Experimental group

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:

Other: PRO-2 Scoring

Other: Faecal Calprotectin Home Test

Reference arm

Active Comparator group

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.

Treatment:

Other: PRO-2 Scoring