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Real-World-Data describing the escalation and deescalation of the dosage of 1600 mg mezalazine tablets in the therapy of an acute flare in ulcerative colitis

Real-World-Data describing the escalation and deescalation of the dosage of 1600 mg mezalazine tablets in the therapy of an acute flare in ulcerative colitis - ROSEN

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025300
Enrollment
300
Registered
2021-05-11
Start date
2021-05-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Ulcerative colitis K51

Interventions

Group 1: Patients with mild to moderate ulcerative colitis (UC) and an acute UC-flare, as assessed by the physician, are included. Patients will start treatment with the mesalazine 1600 mg tablet (ASA

Sponsors

Tillotts Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients - Who are at least 18 years of age at study inclusion - with mild to moderate ulcerative colitis as assessed by the physician - with an acute ulcerative colitis flare as assessed by the physician - in whom treatment with mesalazine 1600 mg tablet is planned

Exclusion criteria

Exclusion criteria: Patients with severe ulcerative colitis as assessed by the physician

Design outcomes

Primary

MeasureTime frame
Collection of real-life data on the dosing behavior of mesalazine: description of the use of mesalazine in treatment reality in patients under therapy with the mesalazine tablet with the currently highest available active strength (1600 mg active ingredient per tablet).

Secondary

MeasureTime frame
Description of: - Adherence of patients with ulcerative colitis to the mesalazine 1600 mg tablet at week 8 and week 14 after an acute flare - Clinical remission/response at week 8 and week 14 - Association between degree of adherence and remission - Correlation between fecal calprotectin (optional for patients, collected only if part of routine care) and Partial Mayo Score - Adherence of patients to previous mesalazine-therapy (for patients who switched from another mesalazine preparation to the mesalazine 1600 mg tablet) - Patient preference for a particular mesalazine-therapy (in patients who have been switched from another oral mesalazine preparation to the mesalazine 1600 mg tablet).

Countries

Germany

Contacts

Public ContactMichelle Rothaug

CED Service GmbH

ROSEN-support@CED-Service.de+49 (0) 431 580 906 46

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026