Defining Predictors of RT Response to Vedolizumab in IBD

The Washington University

Status and phase: Completed; Phase 4

Conditions: Crohn Disease of Small Intestine

Treatments: Drug: Vedolizumab 300 MG Injection [Entyvio]

Study type: Interventional

Funder types: Other

Identifiers

NCT03142321

201705043 -17-001

Details and patient eligibility

About

The overall goal of the study is to develop data that can convincingly guide clinicians on the use and efficacy of vedolizumab in patients with small bowel CD. There is an unmet need to identify response to vedolizumab in small bowel CD using objective endpoints. Current data suggest that MR enterography may meet this unmet need. There is an additional unmet need to develop predictive models incorporating both clinical and baseline radiological and endoscopic variables with higher discriminatory performance in identifying longer term clinical remission with vedolizumab. Finally, this proposal is strengthened by the exploratory studies which may identify new proteomic biomarkers that correlate with longer term radiological response with vedolizumab reflecting its latency of response. If successful, these serum biomarkers may guide a personalized approach to the treatment of small bowel CD with vedolizumab, allowing early identification of PNR, monitoring disease activity and the pharmacodynamics of vedolizumab.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe disease activity small bowel CD (small bowel only or ileocecal only) visible on MRE
• Initiated on Vedolizumab with/without thiopurines or methotrexate
• ≥18 years old

Exclusion criteria

• Pregnancy
• Age <18
• Planned surgery prior to the first follow-up MRE
• Inability to provide informed consent.
• Perianal CD will be excluded since assessment requires performance of additional MRI of the pelvis.
• Individuals with colonic involvement other than involvement of the ascending colon and cecum.
• Inpatient scans will only be included if this is a MRE and adequate small bowel distension with appropriate contrast has been achieved
• If unable to provide informed consent
• Contraindications for MRE including chronic kidney disease that precludes contrast administration, implanted medical devices that are contraindicated for MRE.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Vedolizumab 300 MG Injection [Entyvio]

Experimental group

Description:

Vedolizumab will be initiated at 300 mg intravenous (IV) dosing at 0, 2 and 6 weeks followed by the 1st maintenance with 300 mg IV at week 14. Patients who have not achieved clinical response at week 14 will be eligible to undergo dose escalation to 4 weekly dosing of vedolizumab depending on the judgement of the treating gastroenterologist.

Treatment:

Drug: Vedolizumab 300 MG Injection [Entyvio]