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

NCT07177209 | Recruiting FDA Drug

• 1 other identifier: C5041058
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

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

  Baseline demography.

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

  Study period is up to 1st August 2025 (2008 - 2025).

• Change from Baseline in Faecal Calprotectin (Fcal).

  Study period is up to 1st August 2025 (2008 - 2025).

• Change from Baseline in C-Reactive Protein (CRP).

  Study period is up to 1st August 2025 (2008 - 2025).

• Proportion of patients with colectomies from baseline.

  Study period is up to 1st August 2025 (2008 - 2025).

Study Arms (4)

Cohort A

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

Drug: Non-Interventional Study

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

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

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

Interventions

Non-Interventional Study DRUG

As provided in real world practice

Also known as: etrasimod, ozanimod, upadicitinib, filgotinib, tofacitinib, vedolizumab, guselkumab, ustekinumab, risankizumab, adalimumab, infliximab, golimumab

Cohort A; Cohort B; Cohort C; Cohort D

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

Tadworth, KT207NS, United Kingdom

RECRUITING

Related Links

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

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

etrasimod; ozanimod; GLPG0634; tofacitinib; vedolizumab; guselkumab; Ustekinumab; risankizumab; Adalimumab; Infliximab; golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 16, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)