Observing the effects of etrasimod in adults with moderate to severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effects of etrasimod in adult patients diagnosed with moderate to severe ulcerative colitis. Participants will receive etrasimod as part of their standard care, and their disease activity will be monitored through health questionnaires completed via mobile devices at various timepoints. The study will last for 52 weeks, followed by a 28-day safety follow-up period, allowing researchers to analyze the impact of etrasimod on patients' symptoms compared to their condition before treatment. Inclusion in the study requires that etrasimod is deemed the best treatment option by the physician and that patients have not previously received this medication.

Why it matters

Who can join: the full rules

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 (or a legally acceptable representative)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

Where it's running

• Reddy GI Associates
  Mesa, Arizona, United States Recruiting
• Scripps Clinic Torrey Pines
  La Jolla, California, United States Recruiting
• United Medical Doctors
  Los Alamitos, California, United States Recruiting
• Rocky Mountain Gastroenterology
  Littleton, Colorado, United States Recruiting
• Digestive and Liver Center of Florida Kissimmee
  Kissimmee, Florida, United States Recruiting
• Feinberg School of Medicine Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.