Pragmatic randomised controlled study to assess the effectiveness of two patient management strategies in mild-to-moderate Ulcerative Colitis

Pragmatic randomised controlled study to assess the effectiveness of two patient management strategies in mild-to-moderate Ulcerative Colitis - Ferring Optimise

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52790

Enrollment

Registered

2019-10-08

Start date

2020-03-26

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

irritatable bowel disease (IBD) proctocolitis

Interventions

The monitoring of Mild-to-Moderate Ulcerative Colitis at home with the CalproSmart*-home-test will be compared against monitoring Mild-to-Moderate Ulcerative Colitis at the hospital.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Adult Patients ( >= 18 years old at Baseline) 2) Active Mild-to-moderate Ulcerative Colitis patients defined with: a. Rectal bleeding (RB) subscore >= 1 at Baseline, and b. Mayo endoscopic subscore >= 1, and c. Total of [RB + SF + Mayo endoscopic subscore] between 2 and 6. 3) Patients who were on 5-ASA

Exclusion criteria

Exclusion criteria: 1) Patients with contra-indications to 5-ASA and/or 2nd generation corticosteroids as per SmPC 2) Patients currently on Nonsteroidal anti-inflammatory drug (NSAID) and Proton-pump inhibitor (PPI) treatment as they affect FC levels 3) Patients exposed to immunosuppressants and/or biologics within 6 months prior to Baseline 4) Patients with positive stool culture up to 2-weeks prior Baseline (bacterial pathogens - SSYC, Clostridium Difficile, toxinC, ova and parasites) having received no specific treatment to treat infection 5) Patients not willing to perform FC self-monitoring at home 6) Patients not willing to undergo a flexible sigmoidoscopy/colonoscopy at the end of study 7) Patients currently enrolled in another interventional study 8) Pregnant/breastfeeding woman 9) Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the study activities 10) Inability by the judgement of the investigator to participate in the study for other reasons.

Design outcomes

Primary

Measure	Time frame
Primary study parameters/outcome of the study Percentage of patients with Mayo endoscopic subscore = 0 at 12 months post-randomisation.	—

Secondary

Measure	Time frame
• Percentage of patients with RB = 0 at 12 months post-randomisation • Percentage of patients with SF	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)