Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
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

Short description of the study population

Patients with Crohn's disease (CD) or Ulcerative Colitis (UC), who are being treated with, or initiating treatment with, CT-P13 (or Remicade for the SOC cohort) at the time of study enrolment.

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)

Special population of interest

Other

Special population of interest, other

Crohn’s Disease (CD), Ulcerative Colitis (UC)

Estimated number of subjects

2500
Study design details

Main study objective

1) To characterise the population and drug utilisation patterns of patients treated with CT-P13 for Crohn's disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade2) To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

Outcomes

•Patients’ demo characteristics •Clin and diagnostic characteristics: Relevant med history of CD or UC including prior treatments •CT-P13 treatment: 1)CT-P13 & Remicade switches and reasons for switch, 2) Dose and freq, augmentation/reduction & reasons of changes•Co-therapies related to management of CD or UC•All AEs, SAEs, AESIs and special situation events (e.g. pregnancy) during study, •Clinical assessment of disease activity, data relating to: Harvey Bradshaw Index (HBI) for patients with CD, Partial Mayo Scoring System for Assessment of UC Activity, Montreal classification index for CD, Montreal classification index for UC, and fistula drainage assessment index for CD• Laboratory and imaging results related to the treatment or assessment of CD or UC

Data analysis plan

The statistical analysis for this observational study will be descriptive in nature. Given the expected heterogeneity of patients commonly seen in observational studies, patients will be stratified (eg, UC vs. CD, by subgroup, by country) based on final data available for analysis. Data permitting, post hoc inferential analysis may be used to examine the impact of risk factors or predictors on outcomes of interest, as appropriate.
Documents
Study results
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