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

DESCRIBING PRESCRIPTION PATTERNS IN AN ULCERATIVE COLITIS POPULATION AND GENERATING AN UPDATED ULCERATIVE COLITIS TREATMENT PARADIGM

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Non-Interventional Study

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.

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• United Kingdom
  • Tadworth, United Kingdom, KT207NS
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The Lothian IBD registry (LIBDR) was compiled through a capture-recapture methodology, describes the observed prevalence of IBD in Lothian between 2008 and 2018, and has been maintained as a prospective registry since 1 August 2018 and thus the study period is up to 1st August 2025 (2008 - 2025). The study size is expected to be a defined population of approximately 4000 UC patients, with more than 600 having commenced an advanced therapy. The study period will be from 2008 - 2025.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy.	Drug: Non-Interventional Study; As provided in real world practice; Other Names: adalimumab; tofacitinib; infliximab; risankizumab; vedolizumab; golimumab; etrasimod; ustekinumab; ozanimod; upadicitinib; filgotinib; guselkumab
Cohort B; Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis.	Drug: Non-Interventional Study; As provided in real world practice; Other Names: adalimumab; tofacitinib; infliximab; risankizumab; vedolizumab; golimumab; etrasimod; ustekinumab; ozanimod; upadicitinib; filgotinib; guselkumab
Cohort C; 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.	Drug: Non-Interventional Study; As provided in real world practice; Other Names: adalimumab; tofacitinib; infliximab; risankizumab; vedolizumab; golimumab; etrasimod; ustekinumab; ozanimod; upadicitinib; filgotinib; guselkumab
Cohort D; Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis	Drug: Non-Interventional Study; As provided in real world practice; Other Names: adalimumab; tofacitinib; infliximab; risankizumab; vedolizumab; golimumab; etrasimod; ustekinumab; ozanimod; upadicitinib; filgotinib; guselkumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in Faecal Calprotectin (Fcal).	Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).	Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in C-Reactive Protein (CRP).	Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR).	Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with colectomies from baseline.	Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.	Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with hospitalisations from baseline.	Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis.	Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.	Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR).	Study period is up to 1st August 2025 (2008 - 2025).
Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.	Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR).	Study period is up to 1st August 2025 (2008 - 2025).
Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.	Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR).	Study period is up to 1st August 2025 (2008 - 2025).
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.	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).	From baseline, study period is up to 1st August 2025 (2008 - 2025).

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 1, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Actual): September 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab; Infliximab; Ustekinumab; guselkumab; risankizumab; vedolizumab; ozanimod; tofacitinib; etrasimod; GLPG0634; golimumab
• Other Study ID Numbers: C5041058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No