Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Duke Clinical Research Institute COMPARE Call Center
CONTACT
Lead
University of North Carolina, Chapel Hill
With
COMPARE is a multi-center, observational cohort study that includes both prospective and retrospective components and two patient population cohorts-Crohn's disease (CD) and ulcerative colitis (UC). The study will recruit pediatric IBD patients initiating non-anti-TNF biologics and small molecules that are FDA-approved for adult populations. The primary analyses in each cohort will compare the two most frequently used classes, with all IL-23 agents analyzed as a single class. Secondary comparisons will be conducted for any classes initiated by at least 50 participants. The investigators will also perform a retrospective cohort study using EHR data extracted from participating sites. IL-23 agents could be any of the following medications: * Vedolizumab (trade name Entyvio™) * Ustekinumab (trade name Stelara™) * Risankizumab (trade name Skyrizi™) * Guselkumab (trade name Tremfya™) * Mirikizumab (trade name Omvoh™) * Tofacitinib (trade name Xeljanz™) * Upadacitinib (trade name Rinvoq™) While taking these medications, participants (or parent/caregiver proxies) will complete patient-reported outcome surveys (PROS) at baseline, every 2 months for the first 12 months, and every 6 months during the 2nd and 3rd years of follow-up. The surveys will collect information about the participants' general health and well-being while taking these medications. Clinical follow-up will occur in the context of routine care (e.g., clinic visits, telehealth encounters) for a minimum of 1-year and up to 3 years after the index date, regardless of whether the participant remains on the index treatment. The study anticipates relatively standard follow-up for each participant, based on best clinical practice, while allowing for natural variation. The study will collect data abstracted from the medical charts of enrolled participants. Baseline data, including potential confounders described in the statistical analysis plan, will be collected by sites upon participant enrollment or shortly thereafter. Follow-up data will be collected with each outpatient gastrointestinal (GI) visit, hospitalization, surgery, colonoscopy, imaging test (MRI, CT, intestinal ultrasound), laboratory test (unless electronically captured), IBD medication change, and adverse events. In addition, structured electronic health record (EHR) data on enrolled participants will be extracted using automated queries utilizing the PCORnet® PCORnet Common Data Model (CDM) to supplement case report forms. EHR data extraction will include laboratory values, anthropometrics, emergency department (ED) visits (and diagnosis codes), hospitalizations (and diagnosis codes), antibiotic/antiviral prescriptions, encounter dates, and diagnosis codes for events of special interest (e.g., infections, malignancy, blood clots). The study will collect and record adverse events from participants and their caregivers, as well as via regular EHR queries using the PCORnet® CDM. Prospective enrollment is expected to take approximately 36 months with a minimum follow-up of 12 months for each participant (maximum of 36 months).
Age
1–18
Sex
ALL
Healthy volunteers
Not accepted
