Clinical trial NCT06398626: An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
Official title: A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colitis, Ulcerative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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 United States etrasimod prescribing information and independent from the decision to enroll the patient in this study.

Brief summary: The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult 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 of choice according to the physician and they have not previously taken etrasimod.

All patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.

The study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and \< 65 years at baseline
2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
3. Evidence of a personally signed and dated ICD indicating that the patient has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. The presence of clinical findings suggestive of Crohn's disease
2. Severe extensive colitis evidenced by:

   1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks
   2. 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:

   1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program
   2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)
   3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \[filgotinib, tofacitinib, or upadacitinib\]) or with any other S1P receptor modulator
5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool
6. 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

Primary outcomes:
measure: Proportion of patients with symptomatic remission
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of patients with symptomatic remission
timeFrame: Weeks 24, 36, 52
measure: Proportion of patients with symptomatic response
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with symptomatic response
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with clinical remission
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with steroid-free symptomatic remission
timeFrame: Weeks 24, 36, 52
measure: Proportion of patients with steroid-free clinical remission
timeFrame: Weeks 24, 36, 52
measure: Change from baseline in fatigue
timeFrame: Weeks 12, 24, 36, 52
measure: Change from baseline of bowel urgency
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with a clinically meaningful improvement in bowel urgency
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients in bowel urgency remission
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with complete bowel urgency remission
timeFrame: Weeks 12, 24, 36, 52
measure: Change from baseline in abdominal pain
timeFrame: Weeks 12, 24, 36, 52
measure: Proportion of patients with abdominal pain remission
timeFrame: Weeks 12, 24, 36, 52
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Reddy GI Associates
state: Arizona
city: Valencia
country: United States
facility: Amicis Research Center
state: California
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Lutz
country: United States
facility: Gastro Florida
state: Florida
city: Pembroke Pines
country: United States
facility: Best Choice Medical Research Service
state: Florida
city: Snellville
country: United States
facility: EBGS Clinical Research Center
state: Georgia
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates PA
state: Maryland
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Division of Gastroenterology and Hepatology
state: North Carolina
city: Oklahoma City
country: United States
facility: Hightower Clinical Trial Services
state: Oklahoma
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: Tacoma
country: United States
facility: Washington Gastroenterology
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: