Ulcerative Colitis
Conditions
Brief summary
The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.
Interventions
None listed
Sponsors
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
* 18 years old or above * Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis) * Having received the information sheet
Exclusion criteria
* Participating, at the time of inclusion, in another study using an investigational drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score) | From baseline (inclusion visit) and at 1 year interval after baseline |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index) | From baseline (inclusion visit) and at 1 year interval after baseline |
| Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale) | From baseline (inclusion visit) and at 1 year interval after baseline |
| Occurence/number of adverse events | From baseline (inclusion visit) to year 3 after baseline |
| Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis | From baseline (inclusion visit) to 3 year after baseline |
Countries
France
Outcome results
None listed