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

NCT ID: NCT07177209

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-30

Study Completion Date

2026-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort A

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

Non-Interventional Study

Intervention Type DRUG

As provided in real world practice

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.

Non-Interventional Study

Intervention Type DRUG

As provided in real world practice

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.

Non-Interventional Study

Intervention Type DRUG

As provided in real world practice

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

Non-Interventional Study

Intervention Type DRUG

As provided in real world practice

Interventions

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Non-Interventional Study

As provided in real world practice

Intervention Type DRUG

Other Intervention Names

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etrasimod ozanimod upadicitinib filgotinib tofacitinib vedolizumab guselkumab ustekinumab risankizumab adalimumab infliximab golimumab

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

Walton Oaks, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Other Identifiers

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C5041058

Identifier Type: -

Identifier Source: org_study_id

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