None listed
Conditions
Brief summary
Biologic agents have improved disease outcome for many patients with the inflammatory bowel diseases Crohn's disease and ulcerative colitis. However, about 50% patients fail to respond or lose response to treatment. There is some evidence that treatment failure correlates with low biologic drug trough concentrations and/or the presence of anti-drug antibodies. This study aims to examine this correlation in IBD patients in New Zealand with a view to using measurement of drug concentrations and anti-drug antibodies in those who are failing treatment to guide treatment decisions.
Interventions
This is an observational study. Patients receiving biologic therapy for treatment of inflammatory bowel disease will be recruited. Disease activity will be recorded prior to therapy and during therapy. Blood samples will be collected just prior to a dose to measure concentrations of biologic drug and anti-drug antibodies, and both will be correlated with disease activity. This includes CDAI, HBI and SCCAI. Patients will be seen for blood samples and to record disease activity on between 1 or 3 o
This is an observational study. Patients receiving biologic therapy for treatment of inflammatory bowel disease will be recruited. Disease activity will be recorded prior to therapy and during therapy. Blood samples will be collected just prior to a dose to measure concentrations of biologic drug and anti-drug antibodies, and both will be correlated with disease activity. This includes CDAI, HBI and SCCAI. Patients will be seen for blood samples and to record disease activity on between 1 or 3 occasions after starting therapy, after at least 12 weeks of therapy, when they are failing therapy and again if they change to a second biologic drug, after at least 12 weeks.
Sponsors
University of Otago Christchurch
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with inflammatory bowel disease as determined by standard clinical and endoscopic criteria
Exclusion criteria
Unwilling to provide informed consent
Outcome results
None listed