Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Intensive monitoring schemes
Study drug and medical condition

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

INFLIXIMAB

Medical condition to be studied

Crohn's disease
Colitis ulcerative
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

150
Study design details

Main study objective

Data on the safety and efficacy of biosimilar infliximab in clinical practice in IBD is limited so far. Therefore the aim of the present study is to conduct a prospective, nationwide, multicentre, observational cohort to examine the efficacy and safety of CT-P13 infliximab biosimilar in the induction and maintenance treatment of Crohn’s disease and ulcerative colitis.

Outcomes

The primary outcome of the study is early clinical remission at week 14. Clinical remission in CD was defined as a CDAI of less than 150 points or no fistula drainage according to the fistula drainage assessment. Clinical remission in UC was defined as a partial Mayo score of less than 3 points. Secondary outcomes include early clinical response at week 14, steroid-free clinical remission at week 30, sustained clinical remission and response at week 54, early and sustained biochemical response at week 14 and week 54, mucosal healing at week 54 and safety. Clinical response in CD was defined as a CDAI decrease >70 points or ≥50% reduction in the number of draining fistulas.

Data analysis plan

Data appraisal and statistical analysis will be performed using the SPSS 20.0 software package. Statistical tests include calculating tests of normality, T and D tests, Chi2 test, Chi2 test with Yates' continuity correction and logistic regression.