Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249555
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-01-24
Brief Title:
VOICE-Early Response to Vedolizumab and Ustekinumab in Participants With Crohns Disease A Prospective Observational Study
Sponsor:
Alimentiv Inc
Organization:
Alimentiv Inc
Study Overview
Official Title:
VOICE-Characterization of Early Response to Vedolizumab and Ustekinumab in Participants With Crohns Disease Using Patient-Reported Outcome Measures A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VOICE
Brief 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
Detailed Description:
Vedolizumab VDZ a monoclonal antibody that selectively targets intestinal T-cell trafficking is an effective and safe treatment for moderately to severely active Crohns disease CD Recent evidence from open-label blinded endpoint studies such as VERSIFY and LOVE-CD provide further support for the efficacy of VDZ in achieving clinical endoscopic histologic and radiologic disease improvement in CD Despite these data VDZ is generally perceived to have a slower onset of action than other biologics including tumor necrosis factor TNF antagonists and ustekinumab UST This perception largely emanates from the results of the VDZ pivotal for CD GEMINI 2 where efficacy was assessed at Week 6 after only 2 doses in a largely refractory population However in clinical practice VDZ induction consists of 3 doses of VDZ 300 mg administered intravenously at weeks 0 2 and 6 instead of the 2 doses used in the pivotal trials In recent clinical trials induction endpoints for therapeutics in CD are now typically measured at least after Week 12 Accordingly it is uncertain whether the generally held perception of a relatively slow onset of action for VDZ is accurate Moreover it should also be noted that the perception of a slow onset of action has also been conflated to infer that VDZ is a relatively less effective induction therapy in CD than TNF antagonists or UST Further data to evaluate these issues are needed
Rapidity of symptom resolution which is commonly used as a surrogate for speed of onset is a priority for patients and clinicians It is therefore important to better understand the kinetics of symptom improvement captured using patient-reported outcomes PROs in patients initiating VDZ for treatment of CD
Rapidity of symptom resolution which is commonly used as a surrogate for speed of onset is a priority for patients and clinicians It is therefore important to better understand the kinetics of symptom improvement captured using patient-reported outcomes PROs in patients initiating VDZ for treatment of CD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None