Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population (EFFECT-1LAT)

Pfizer

Status: Not yet enrolling

Conditions: Ulcerative Colitis

Treatments: Drug: Non-Interventional Study

Study type: Observational

Funder types: Industry

Identifiers

NCT07177209

C5041058

Details and patient eligibility

About

Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population

Full description

Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patient enrolled in IBD registry from 2009
2. >18 years at time of diagnosis.
3. Diagnosis of Ulcerative Colitis.
4. Patient data entered during the study period.
5. Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)

Trial design

4,000 participants in 4 patient groups

Cohort A

Description:

Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy.

Treatment:

Drug: Non-Interventional Study

Cohort B

Description:

Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis.

Treatment:

Drug: Non-Interventional Study

Cohort C

Description:

Patients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months.

Treatment:

Drug: Non-Interventional Study

Cohort D

Description:

Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis

Treatment:

Drug: Non-Interventional Study