VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study
Alimentiv Inc.
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.
Description
Vedolizumab (VDZ), a monoclonal antibody that selectively targets intestinal T-cell trafficking, is an effective and safe treatment for moderately to severely active Crohn's 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 the interleukin (IL)-12/23 antagon…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging. 2. Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR \[if approved for the treatment of CD during the recruitment period for this study\]) for the first time in accordance with the product label, as determined by the treating physician. 3. Participant has a baseline PROMIS Pain Interference-SF sco…
Interventions
- DrugVedolizumab (VDZ)
Participants will receive VDZ as part of routine care.
- DrugUstekinumab (UST)
Participants will receive UST as part of routine care.
- DrugRisankizumab (RISA)
Participants will receive RISA as part of routine care.
- DrugGuselkumab (GUS)
Participants will receive GUS as part of routine care.
- DrugMirikizumab (MIR)
Participants will receive MIR as part of routine care.
Locations (25)
- GI Alliance - Sun CitySun City, Arizona
- Digestive and Liver Center of FloridaKissimmee, Florida
- Northwestern UniversityEvanston, Illinois
- University of IowaIowa City, Iowa
- University Medical Center New OrleansNew Orleans, Louisiana
- Brigham and Women's HospitalChestnut Hill, Massachusetts