Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée

Ferring Pharmaceuticals80 sites in 1 country812 target enrollmentJune 2011

ConditionsUlcerative Colitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Ferring Pharmaceuticals
Enrollment: 812
Locations: 80
Primary Endpoint: Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

October 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ferring Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)

Time Frame: From baseline (inclusion visit) and at 3 year interval after baseline

Secondary Outcomes

Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis(From baseline (inclusion visit) to 3 year after baseline)
Occurence/number of adverse events(From baseline (inclusion visit) to year 3 after baseline)
Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale)(From baseline (inclusion visit) and at 3 year interval after baseline)
Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)(From baseline (inclusion visit) and at 3 year interval after baseline)