An interventional study of Faecal Calprotectin Home Test and PRO-2 Scoring in Mild-to-moderate Ulcerative Colitis, sponsored by Ferring Pharmaceuticals. Completed at 42 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ferring Pharmaceuticals · Not applicable, Interventional, and Other
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 250 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Other: Faecal Calprotectin Home Test · Other: PRO-2 Scoring
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.
Other: PRO-2 Scoring
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.
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.
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.
Time frame: At 12 months
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
Time frame: At 12 months
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
Time frame: At 12 months
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
Time frame: At 12 months
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).
Time frame: From Baseline over 12 Months
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.
Time frame: From Baseline over 12 Months
Percentage of Participants Escalated to Rescue Therapy
Rescue therapy included systemic corticosteroids/ immunosuppressants /biologics.
Time frame: Over 12 months
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.
Time frame: From Baseline over 12 Months
Number of Hospitalization Days
Number of hospitalization days will be determined by UC related medical resources.
Time frame: Over 12 months
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.
Time frame: Over 12 months
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.
Time frame: Over 12 months
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.
Time frame: Over 12 months
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Ferring Pharmaceuticals