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Vedolizumab for Crohn's Disease (VOICE Trial)

N/A
Recruiting
Research Sponsored by Alimentiv Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 2, 6, 14, 22, 30, 38, 46, and 52
Awards & highlights

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.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 2, 6, 14, 22, 30, 38, 46, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 6, 14, 22, 30, 38, 46, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess time of onset of biologic therapy in pain interference
Secondary outcome measures
To assess early change in patient-reported symptoms within the PRO-2 through Week 14.
To assess early change in patient-reported symptoms within the PROMIS - Ability to Participate in Social Roles and Activities - Short Form through Week 14
To assess early change in patient-reported symptoms within the PROMIS - Anxiety - Short Form through Week 14
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: VedolizumabExperimental Treatment1 Intervention
Group one will include participants who will be starting Vedolizumab as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.
Group II: UstekinumabExperimental Treatment1 Intervention
Group two will include participants who will be starting Ustekinumab as part of routine care. Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.

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Who is running the clinical trial?

Alimentiv Inc.Lead Sponsor
13 Previous Clinical Trials
2,904 Total Patients Enrolled
TakedaIndustry Sponsor
1,227 Previous Clinical Trials
4,222,205 Total Patients Enrolled
~200 spots leftby Mar 2026
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