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

May 11, 2026 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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).
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.
Time Frame: 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).
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
Time Frame: 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).
Baseline demography.
Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
Time Frame: 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).
Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in Faecal Calprotectin (Fcal).
Time Frame: 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).
Study period is up to 1st August 2025 (2008 - 2025).
Change from Baseline in C-Reactive Protein (CRP).
Time Frame: 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).
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with colectomies from baseline.
Time Frame: 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.
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with hospitalisations from baseline.
Time Frame: 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.
Study period is up to 1st August 2025 (2008 - 2025).
Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
Time Frame: Study period is up to 1st August 2025 (2008 - 2025).
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.
Time Frame: Study period is up to 1st August 2025 (2008 - 2025).
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.
Time Frame: 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).
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.
Time Frame: 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).
From baseline, study period is up to 1st August 2025 (2008 - 2025).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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