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

N/AActive Not RecruitingNCT07177209

Pfizer4,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Ulcerative Colitis

Interventions

Non-Interventional StudyDRUG

As provided in real world practice

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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)

Locations (1)

Pfizer

Tadworth, United Kingdom

Outcomes

Primary Outcomes

Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.

Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).

Time frame: 6-24 months from UC diagnosis.

Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.

Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR).

Time frame: 24 months

Secondary Outcomes

Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.

Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR).

Time frame: Baseline demography.

Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.

Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR).