Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Pa… (NCT04835506) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial
United States124 participantsStarted 2021-11-01
Plain-language summary
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive.
✓. Diagnosis of IBD prior to screening using standard endoscopic, histologic, or radiologic criteria. Participants with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD or UC. Enrollment of participants with UC will be capped at 49% of the planned study population (maximum 61 participants).
✓. Moderately to severely active IBD, defined by a total CDAI score between 220 and 450 points for CD or a partial Mayo Score (PMS) \> 4 for UC (including a rectal bleeding subscore \[RBS\] ≥ 1), and at least 1 of the following:
✓. Elevated CRP (\> upper limit of normal)
✓. Elevated FC (\> 250 μg/g)
✓. SES-CD \> 6 (SES-CD \> 3 for isolated ileal disease) for CD only and a Mayo endoscopic subscore (MES) ≥ 2 for UC only.
✓. Physician intends to prescribe IFX as part of the usual care of the subject.
✓. No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol
Exclusion criteria
✕. Participants with any of the following IBD-related complications:
✕. Abdominal or pelvic abscess, including perianal
✕. Presence of stoma, ileal pouch-anal anastomosis, or ostomy
✕. Isolated perianal disease
✕. Obstructive disease, such as obstructive stricture
✕. Short gut syndrome
✕. Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD for CD or PMS, PRO2, or MES for UC)