PROxIMO: Efficacy of proactive therapeutic drug monitoring and dose adjustment of infliximab based on point of care testing for inflammatory bowel disease

Phase 4

Active, not recruiting

• Conditions: lcerative Colitis; Crohn's Disease; Ulcerative Colitis; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12616001031459
• Lead Sponsor: Alfred Health Pharmacy Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adults over 18 years.
Diagnosis of moderate to severe Crohn's disease or Ulcerative Colitis
Currently receiving maintenance infliximab therapy (ie have commenced infliximab therapy at least 14 weeks prior to recruitment)
Receiving their infliximab therapy and disease monitoring through Alfred Health

Exclusion Criteria

Unable or unwilling to provide informed consent
Patients with detectable anti-drug antibodies (ADAs) and undetectable trough levels
Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients that obtain a therapeutic (3-7ug/mL) infliximab trough concentration using an individualised mg/kg weight based dose adjustment according to an algorithm directed by a novel POC infliximab trough assay[Infliximab trough levels will be assessed every 6-8 weeks based on the patient's infliximab dosing schedule, for 12 months post commencement of the intervention]