Ulcerative ColitisEFFECT-1LATNCT07177209
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
An observational study of Ulcerative Colitis, run by Pfizer at 1 site in United Kingdom.
Trial summary
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Non-Interventional Study
- How many people
- 4,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Non-Interventional Study
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyDrug
Also called etrasimod, ozanimod, upadicitinib, filgotinib
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 months
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline, study period is up to 1st August 2025 (2008 - 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Apr 2026
- Primary completion30 Oct 2026
- Study completion30 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177209
- Sponsor's protocol ID
- C5041058
- Acronym
- EFFECT-1LAT
- Status last verified
- Nov 2026
- First submitted
- 1 Aug 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESCRIBING PRESCRIPTION PATTERNS IN AN ULCERATIVE COLITIS POPULATION AND GENERATING AN UPDATED ULCERATIVE COLITIS TREATMENT PARADIGM
- ClinicalTrials.gov ID
- NCT07177209
- Acronym / sponsor ID
- EFFECT-1LAT / C5041058
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Non-Interventional StudyPatients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. |
| Cohort B | – | Drug: Non-Interventional StudyPatients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis. |
| Cohort C | – | Drug: Non-Interventional StudyPatients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months. |
| Cohort D | – | Drug: Non-Interventional StudyPatients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: etrasimod, ozanimod, upadicitinib, filgotinibAs provided in real world practice | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
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).
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).
10 secondary outcomes
Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
Time frame: 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).
Change from Baseline in Faecal Calprotectin (Fcal).
Time frame: 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).
Proportion of patients with colectomies from baseline.
Time frame: 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).
Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
Time frame: 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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Pfizer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.