An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis
ConditionColitis, Ulcerative
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorPfizer
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and < 65 years at baseline
Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC
Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study
Disqualifiers
The presence of clinical findings suggestive of Crohn's disease
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
Current evidence of acute severe UC, fulminant colitis, or toxic megacolon
Patients with a stoma or planned UC surgical intervention requiring hospitalization
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Etrasimod
DrugAs provided in real world practice
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Adult patients with ulcerative colitis taking etrasimod1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with symptomatic remission
Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Time frame
Week 12Secondary outcomes
1
Proportion of patients with symptomatic remission
Symptomatic remission is defined as partial Modified Mayo Score (pMMS) stool frequency subscore (SFS) = 0 (or = 1 with a ≥ 1-point decrease from baseline) and (RBS) rectal bleeding subscore = 0
Time frame
Weeks 24, 36, 522
Proportion of patients with symptomatic response
Symptomatic response defined as a decrease from baseline ≥ 30% in pMMS composite RBS and SFS
Time frame
Weeks 12, 24, 36, 523
Proportion of patients with symptomatic response
Symptomatic response defined as a decrease from baseline ≥ 20% in pMMS composite RBS and SFS
Time frame
Weeks 12, 24, 36, 524
Proportion of patients with clinical remission
Clinical remission is defined as a pMMS ≤ 2 points, with no individual subscores \> 1 point.
Time frame
Weeks 12, 24, 36, 52 Source ClinicalTrials.gov