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Completed

NCT Number: NCT04340895

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

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.

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Key information

Conditions

Mild-to-moderate Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vojenska nemocnice Brno p.o., Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faecal Calprotectin Home Test

Other

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.

PRO-2 Scoring

Other

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 outcomes

  1. Percentage of Participants with Mayo Endoscopic Sub-score = 0

    Time frame: 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 outcomes

  1. Percentage of Participants with Rectal Bleeding = 0

    Time frame: 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

  2. Percentage of Participants with Stool Frequency <=1

    Time frame: 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

  3. Percentage of Participants with Mayo Endoscopic Sub-score <=1

    Time frame: 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

  4. Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Time frame: 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).

  5. Change in Short Form Questionnaire-36 (SF-36)

    Time frame: 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.

  6. Percentage of Participants Escalated to Rescue Therapy

    Time frame: Over 12 months

    Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics.

  7. Change in Work Productivity and Activity Impairment: Ulcerative Colitis (WPAI: UC) Questionnaire

    Time frame: 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.

  8. Number of Hospitalization Days

    Time frame: Over 12 months

    Number of hospitalization days will be determined by UC related medical resources.

  9. Number of Outpatients Visits and Calls (Outside of Study Schedule)

    Time frame: Over 12 months

    Number of outpatients visits and calls (outside of study schedule) will be determined by UC related medical resources.

  10. Number of Ulcerative Colitis Related Procedures and/or Surgeries

    Time frame: Over 12 months

    Number of UC related procedures and/or surgeries will be determined by UC related medical resources.

  11. Faecal Calprotectin Value Changes at the Defined Study Time Points (Interventional Arm Only)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Pragmatic Randomized Controlled Study to Assess the Effectiveness of Two Patient Management Strategies in Mild to Moderate Ulcerative Colitis

Acronym: OPTIMISE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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