A Collaborative Study to Evaluate the Efficacy of Prospective Post-Induction Infliximab Dosing Based on Trough Levels at week 12 and 28 in Subjects with Crohn’s Disease (CD) and Ulcerative Colitis (UC)

Project: Research project

Project Details

Description

Inflammatory bowel diseases (IBD) are debilitating, relapsing chronic conditions affecting several millions of people in the US and around the world. Crohn’s disease (CD) and ulcerative colitis (UC) are the two major spectra of this disease (1). Anti-tumor necrosis factor (TNF) agents, e.g. adalimumab and infliximab, have been used in the treatment of these conditions, and nowadays, are one of the most effective drugs to treat moderate to severe CD and UC. We hypothesize that adjusting the infliximab dose based on trough levels at weeks 12 and 28 after initiation of therapy will improve rates of steroid-free clinical, and endoscopic remissions at week 52 in UC and CD patients. Primary Outcome Measures: 1. Achievement of steroid-free clinical remission (binary outcome) at week 52 and 2. Mucosal healing (binary outcome) at week 52. Subjects will undergo the screening visit. Eligible subjects will receive standard infliximab loading doses of 5 mg/kg at weeks 0, 2, and 6. At weeks 12 and 28, subjects will have 3 infliximab level checked. The primary endpoint assessment is at week 52. At weeks 12, 28, and 52, all subjects will undergo physical examination and study personnel will record each subject’s interval medical history, assess adverse events and disease activity. Subjects will also have CBC, CMP, CRP and fecal calprotectin checked at each visit. The total study follow-up will be 52 weeks. At week 52, subjects will undergo a repeat colonoscopy to reassess disease activity. SES-CD and Mayo score for UC subjects will be again calculated.
StatusFinished
Effective start/end date9/1/178/31/19

Funding

  • Northwestern Memorial Hospital (Agmt 12 Sgnd 10/9/17)
  • Digestive Health Foundation (Agmt 12 Sgnd 10/9/17)

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