Who is sponsoring CORE Practice?

CORE Practice is sponsored by Ferring Pharmaceuticals.

What condition does CORE Practice study?

CORE Practice studies Ulcerative Colitis.

What drugs are being tested in CORE Practice?

Interventions: budesonide MMX®.

What is the status of CORE Practice?

CORE Practice is currently COMPLETED.

Last reviewed 2019-11-18 · How we verify

A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice (CORE Practice)

NCT02586259 COMPLETED

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.

Details

Lead sponsor	Ferring Pharmaceuticals
Status	COMPLETED
Enrolment	378
Start date	2015-12
Completion	2018-04-05

Conditions

Ulcerative Colitis

Interventions

budesonide MMX®

Primary outcomes

Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score — From Day 1 to end of induction treatment (recommended duration up to 8 weeks)

Countries

Canada, Germany, Ireland, Italy, Netherlands, Poland, Sweden, United Kingdom