Optimizing Infliximab Treatment for Inflammatory Bowel Disease
Multicentric Evaluation of a Strategy for Early Infliximab Optimization Among Adult Inflammatory Bowel Disease Patients
This study is testing a new way to give infliximab to adults with moderate-to-severe inflammatory bowel disease who haven't improved with steroids, to see if personalized dosing can help them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Santiago) |
| Trial ID | NCT06758024 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the treatment of inflammatory bowel disease (IBD) by using infliximab, a monoclonal antibody that targets tumor necrosis factor. It aims to monitor and optimize infliximab dosing through a dashboard-guided approach, which considers individual patient factors and laboratory parameters. The study will involve adult inpatients with moderate-to-severe IBD who have not responded to intravenous corticosteroids and require infliximab therapy. By tailoring the treatment based on therapeutic drug monitoring, the researchers hope to enhance patient outcomes and reduce the incidence of treatment failure.
Who should consider this trial
Good fit: Ideal candidates are adult inpatients with Crohn's disease or ulcerative colitis experiencing moderate-to-severe flares who have failed intravenous corticosteroids.
Not a fit: Patients with non-controlled infectious diseases, those under 18 years, or those who cannot comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of IBD, improving symptoms and reducing the need for more aggressive treatments.
How similar studies have performed: Previous studies have shown that therapeutic drug monitoring can significantly improve treatment outcomes in similar patient populations, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult inpatients with Crohn's disease, ulcerative colitis or inflammatory bowel disease-unclassified. * Moderate-to-severe flare who fail to iv steroids and require infliximab as per standard of care by treating gastroenterologist Exclusion Criteria: * Participant younger than 18 years * Non-controlled infectious diseases * Permanent ileostomy or Ileal pouch-anal anastomosis * Pregnancy * Patients do not consent to participate in study * Patients unable to comply with protocol
Where this trial is running
Santiago
- Pontificia Universidad Catolica of Chile — Santiago, Chile (Recruiting)
Study contacts
- Study coordinator: Cristian Hernández-Rocha Cristian Hernández-Rocha, MD
- Email: caherna4@uc.cl
- Phone: 56-22-3543838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.