NCT06249555

VOICE-Early Response to Vedolizumab and Ustekinumab in Participants With Crohn's Disease: A Prospective Observational Study

Name: Clinical Trial NCT06249555
Creator: Alimentiv Inc.
Keywords: Crohn's Disease, Vedolizumab (VDZ), drug, clinical trial

VOICE-Characterization of Early Response to Vedolizumab and Ustekinumab in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study

Alimentiv Inc.·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Crohn's Disease
Drug/Device/Intervention: Vedolizumab (VDZ)
Study type: Observational
Intervention type: drug

Sponsor & location

Primary sponsor: Alimentiv Inc.

Timeline & enrollment

Phase: N/A
Start date: Mar 31, 2024
End date: Sep 30, 2026
Enrollment: 300 participants

Primary outcome

To assess time of onset of biologic therapy in pain interference

Summary

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

ICD-10 classifications

Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06249555
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06249555 through Pure Global AI's free database. This phase not specified trial is sponsored by Alimentiv Inc. and is currently Not yet recruiting. The study focuses on Crohn's Disease. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.