Ulcerative Colitis
Conditions
Brief summary
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
Detailed 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.
Interventions
DRUGNon-Interventional Study
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 months | 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). |
| Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis. | 6-24 months from 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with hospitalisations from baseline. | Study period is up to 1st August 2025 (2008 - 2025). | Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
| Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis. | Study period is up to 1st August 2025 (2008 - 2025). | Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR). |
| Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice. | Study period is up to 1st August 2025 (2008 - 2025). | Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
| Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation. | Study period is up to 1st August 2025 (2008 - 2025). | Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR). |
| Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis. | From baseline, study period is up to 1st August 2025 (2008 - 2025). | Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR). |
| Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest. | Baseline demography. | 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). |
| Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis. | Study period is up to 1st August 2025 (2008 - 2025). | Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
| Change from Baseline in C-Reactive Protein (CRP). | Study period is up to 1st August 2025 (2008 - 2025). | Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
| Change from Baseline in Faecal Calprotectin (Fcal). | Study period is up to 1st August 2025 (2008 - 2025). | Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
| Proportion of patients with colectomies from baseline. | Study period is up to 1st August 2025 (2008 - 2025). | Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Countries
United Kingdom
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed