Mild-to-moderate Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis, Management strategies, Pragmatic trial
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.
Interventions
OTHERFaecal 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.
OTHERPRO-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.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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). |
| 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. |
| Percentage of Participants Escalated to Rescue Therapy | Over 12 months | Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics. |
| 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 |
| Number of Hospitalization Days | Over 12 months | Number of hospitalization days will be determined by UC related medical resources. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Czechia, Hungary, Italy, Netherlands, Poland, Slovakia
Outcome results
None listed