Colitis, UlcerativeEFFECT-UCNCT06294925
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
An observational study of Colitis, Ulcerative, run by Pfizer at 41 sites in 3 countries.
Trial summary
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Etrasimod
- How many people
- 360 participants
- Where
- 41 sitesin 3 countries
- Study dates
- 8 May 2024to 13 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study.
Who may be able to join
- Male and female patients ≥18 and <65 years of age at baseline
- Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Who cannot join
- Presence of clinical findings suggestive of Crohn's disease.
- Severe extensive colitis evidenced by:
- Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (eg, colectomy) within 12 weeks.
- Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.
- 4. Prior/Concomitant Therapy:
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- any previous exposure to etrasimod including participation in the etrasimod clinical program.
- any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.
- Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
Trial locations and contacts
41 sites in 3 countries.
41 sites in 3 countries
Germany16 sites
MVZ Gastroenterologie Aachen
Aachen, 52064
Praxis Heil und Müller
Andernach, 56626
MVZ für Gastroenterologie am Bayerischen Platz
Berlin, 10825
Evangelisches Krankenhaus Kalk
Cologne, 51103
MVZ Dachau
Dachau, 85221
Interdisziplinares Crohn Colitis Centrum
Frankfurt am Main, 60594
Gastrofreiburg
Freiburg im Breisgau, Breisgau, 79102
Facharztpraxis für Gastroenterologie
Grevenbroich, 41515
Studiengesellschaft BSF UG.
Halle, 06108
Praxis für Gasteroenterologie
Heidelberg, 69115
Gastroenterologie OpernstraBe
Kassel, Hesse, 34117
Praxis für Gasteroenterologie Lübeck
Lübeck, 23560
Klinikum Lüneburg
Lüneburg, 21339
Internistische Praxengemeinschaft Oldenburg
Oldenburg, 10115
Magen-Darm-Zentrum Remscheid
Remscheid, 42859
CED am Rhein
Wesseling, 50389
United Kingdom15 sites
Northern Care Alliance NHS Foundation Trust, Greater Manchester
Crumpsall, M8 5RB
Western General Hospital
Edinburgh, Scotland, EH4 2XU
NHS Greater Glasgow and Clyde
Glasgow, Lanarkshire, G4 0SF
Tunbridge Wells Hospital
Kent, TN2 4QJ
Barts Health NHS Trust, The Royal London Hospital
London, E1 1BB
St. Mark's Hospital
London, HA1 3UJ
University College London Hospital
London, NW1 2PG
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH
Kings College Hospital
London, SE59RS
St George's Hospital - St George's Healthcare Nhs Trust
London, SW17 0QT
Imperial College Healthcare NHS
London, W2 1PG
Royal Gwent Hospital
Newport, NP20 2UB
Nottingham University Hospitals NHS Trust, Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Southampton University Hospitals NHS Trust
Southampton, SO16 6YD
Canada10 sites
Kelowna Gastroenterology Associates
Kelowna, British Columbia, V1Y 6J6
London Health Sciences Centre
London, Ontario, N6A5A5
CHUM
Montreal, Quebec, H2X 3E4
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C4
Columbia Medical Building
New Westminster, British Columbia, V3L 3E3
Ottawa Hospital
Ottawa, Ontario, K1H8L6
Richmond Hospital
Richmond, British Columbia, V7C 5L9
Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9
Providence Health Care (PHC)
Vancouver, British Columbia, V6Z 2K5
About this study
Official title: EFFECTIVENESS OF ETRASIMOD ON DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN ULCERATIVE COLITIS - EFFECT-UC
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
Read more
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.
- Conditions
- Colitis, Ulcerative
- Being tested
- Etrasimod
- Keywords
- patient related outcomes, real world data, S1P modulator, Symptomatic Remission, Corticosteroid free symptomatic remission
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtrasimodDrug
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving etrasimod for ulcerative colitis | Not described Receives: Drug: Etrasimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Measured: Week 12
Proportion of patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Measured: Week 52
Secondary outcomes (3)
Proportion of patients with clinical response
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Measured: Week 12
Proportion of patients with clinical response.
Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission.
Measured: Week 52
Proportion of corticosteroid-free patients with symptomatic remission
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start8 May 2024
- Primary completion13 May 2027 (estimated)
- Study completion13 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies 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
- Prospective
- Enrolment
- 360 participants (estimated)
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
- NCT06294925
- Sponsor's protocol ID
- C5041041
- Other IDs
- EFFECT-UC
- Acronym
- EFFECT-UC
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Publications
Moran GW, Radford SJ, Walsh A, Battat R, McLean M, Kudela M, Binder E, Kulchytska N, Sahin B, Helwig U, Irving PM. Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol. BMJ Open. 2025 Dec 24;15(12):e106141. doi: 10.1136/bmjopen-2025-106141.
PubMed 41448713
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF ETRASIMOD ON DISEASE ACTIVITY AND PATIENT-REPORTED OUTCOMES IN ULCERATIVE COLITIS - EFFECT-UC
- ClinicalTrials.gov ID
- NCT06294925
- Acronym / sponsor ID
- EFFECT-UC / C5041041
- Conditions
- Colitis, Ulcerative
- Keywords
- patient related outcomes, real world data, S1P modulator, Symptomatic Remission, Corticosteroid free symptomatic remission
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 13 May 2027 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 6 Mar 2024 (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.
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving etrasimod for ulcerative colitis | – | Drug: Etrasimod |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study.
Key inclusion criteria (3 listed)
- Male and female patients ≥18 and <65 years of age at baseline
- Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Key exclusion criteria (10 listed)
- Presence of clinical findings suggestive of Crohn's disease.
- Severe extensive colitis evidenced by:
- <!-- -->
- Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.
- Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
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 |
|---|---|---|
| EtrasimodAs provided in real world practice | Drug | Patients receiving etrasimod for ulcerative colitis |
Primary outcome
Proportion of patients with symptomatic remission
Time frame: Week 12
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
Proportion of patients with symptomatic remission
Time frame: Week 52
Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease.
3 secondary outcomes
Proportion of patients with clinical response
Time frame: Week 12
Proportion of patients with clinical response.
Time frame: Week 52
Proportion of corticosteroid-free patients with symptomatic remission
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 41448713Moran GW, Radford SJ, Walsh A, Battat R, McLean M, Kudela M, Binder E, Kulchytska N, Sahin B, Helwig U, Irving PM. Effectiveness of etrasimod on disease activity and patient-reported outcomes in ulcerative colitis-EFFECT-UC: a non-interventional, multinational, prospective cohort study protocol. BMJ Open. 2025 Dec 24;15(12):e106141. doi: 10.1136/bmjopen-2025-106141.
- 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
41 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colitis, Ulcerative, run by Pfizer at 41 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, United Kingdom, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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 with symptomatic remission (time frame: Week 12). 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?
On the ClinicalTrials.gov record for NCT06294925, which also lists 1 linked publication.
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 30 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.