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.
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.
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.
Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a [V1.1]).
Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice).
Participant has CD-related surgery planned or anticipated during the study.
Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion.
Participant has an active infection at baseline requiring intravenous systemic antibiotics.
Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening.
This study will be conducted in US and Canadian participants with CD prescribed VDZ or IL-23 antagonists for the first time. Approximately 300 participants with CD who are initiating first-time treatment with VDZ or UIL-23 antagonists will be enrolled in this study.
Cohort
Prospective
Vedolizumab (VDZ)
DrugParticipants will receive VDZ as part of routine care.
Ustekinumab (UST)
DrugParticipants will receive UST as part of routine care.
Risankizumab (RISA)
DrugParticipants will receive RISA as part of routine care.
Guselkumab (GUS)
DrugParticipants will receive GUS as part of routine care.
Mirikizumab (MIR)
DrugParticipants will receive MIR as part of routine care.
To assess time of onset of biologic therapy in pain interference
Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score
To assess time of onset of biologic therapy in multiple QOL and functioning domains
Time to meaningful clinical improvement for each individual PROMIS domain, defined as a ≥ 2-point change in the direction of improvement in the respective PROMIS domain T-score (Note: A higher PROMIS domain T-score represents more of the concept being measured. For the Ability to Participate in Social Roles and Activities domain an increase in T-score
To assess the efficacy of therapy in inducing a meaningful clinical improvement in pain interference through Week 52 through a reduction in PROMIS - Pain Interference - Short Form Scores.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in fatigue through Week 52 through a reduction in PROMIS - Fatigue - Short Form Scores.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in anxiety through Week 52 through a reduction in PROMIS - Emotional Distress - Anxiety - Short Form Scores.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
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Alimentiv Inc.
Lead sponsor
Takeda
Collaborator
