Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Pharmacokinetic study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

AZATHIOPRINE
INFLIXIMAB
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)

Estimated number of subjects

63
Study design details

Main study objective

We prospectively observed a group of pediatric patients with Crohn’s disease on combination therapy (infliximab and azathioprine) in order to find suitable 6-thioguanine (as active metabolite of thiopurine therapy) cutoff levels in erythrocytes. In children, the target 6-thioguanine levels in combination therapy are not yet known.

Outcomes

Evaluation of the relationship between 6-thioguanine levels and infliximab through levels, - Investigation of thiopurine metabolites as potential predictors of relapse - Revealing non-adherence to thiopurine therapy and ‘shunters’ - Evaluation of possible relationship between infliximab and thiopurine metabolites levels and markers of disease activity

Data analysis plan

For data analysis R statistical software is used. Since we collected data from repeated measurements (from each patient), linear mixed model analysis was performed. When searching for optimal cutoffs cross-validated ROC analysis were used. To assess the risk of loss of response to infliximab survival analysis was performed.