Ulcerative Colitis
Conditions
Brief summary
This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.
Interventions
OTHERMesalazine
Patient's treated with oral Mesalazine
Sponsors
Ferring Arzneimittel GmbH
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are treated for the first time with oral PENTASA®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or * Following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral PENTASA®, * The patients (≥ 18 years) have been informed about the NIS and have given their written consent for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient compliance: Measured by patient response to a questionnaire | Month 0 - Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire | Month 0 - Month 12 | — |
| Reasons for the therapeutic decision of the physician: Measured by physician responses | Month 0 | — |
| Patient's level of information: Measured by patient response to a questionnaire | Month 0 - Month 12 | — |
| Ulcerative Colitis Disease Activity Index (UCDAI) | Month 0 - Month 12 | UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional) |
| Adverse drug reactions: measured by number of patients and event severity | Month 0 - Month 12 | — |
| Laboratory parameters of predefined blood measurements | Month 0- Month 12 | Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT) |
Countries
Germany
Outcome results
None listed