An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

— ENDEAVOUR-UC  

Official title:

A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398626
• Other study ID #: C5041047
• Secondary ID: ENDEAVOUR-UC
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: February 28, 2028

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 28, 2028
• Est. primary completion date: May 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Etrasimod
As provided in real world practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 12
Secondary	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	Weeks 24, 36, 52
Secondary	Proportion of patients with symptomatic response	Symptomatic response defined as a decrease from baseline = 30% in pMMS composite RBS and SFS	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with symptomatic response	Symptomatic response defined as a decrease from baseline = 20% in pMMS composite RBS and SFS	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with clinical remission	Clinical remission is defined as a pMMS = 2 points, with no individual subscores > 1 point.	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with steroid-free symptomatic remission	Steroid-free symptomatic remission is defined as patients in symptomatic remission who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with steroid-free clinical remission	Steroid-free clinical remission is defined as patients in clinical remission (using a pMMS) who did not take any corticosteroid treatment for 8 weeks prior to the visit/timepoint	Weeks 12, 24, 36, 52
Secondary	Change from baseline in fatigue	Change from baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score; Normalization of fatigue is defined as a FACIT Fatigue score = 40.1	Weeks 12, 24, 36, 52
Secondary	Change from baseline of bowel urgency	Change from baseline in bowel urgency on a 0 (no urgency) - 10 (worst possible urgency) numeric rating scale	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with a clinically meaningful improvement in bowel urgency	Clinically meaningful improvement in bowel urgency is defined as = 3-point decrease from baseline among patients with baseline bowel urgency score = 3	Weeks 12, 24, 36, 52
Secondary	Proportion of patients in bowel urgency remission	Bowel urgency remission is defined as a bowel urgency score = 1 among patients with a baseline bowel urgency score = 3 and the overall population	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with complete bowel urgency remission	Complete bowel urgency remission is defined as a bowel urgency Numeric Rating Scale score = 0	Weeks 12, 24, 36, 52
Secondary	Change from baseline in abdominal pain	Change from baseline in abdominal pain on a 0 (no pain) - 10 (pain as bad as can imagine) numeric rating scale	Weeks 12, 24, 36, 52
Secondary	Proportion of patients with abdominal pain remission	Abdominal pain remission is defined as an abdominal pain Numeric Rating Scale score = 0	Weeks 12, 24, 36, 52