Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Study drug and medical condition

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

VEDOLIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(L04AA33) vedolizumab
vedolizumab

Medical condition to be studied

Colitis ulcerative
Crohn's disease
Population studied

Short description of the study population

Patients with ulcerative colitis (UC) and Crohn's disease (CD) who were on vedolizumab treatment initiated 10 to 14 weeks prior to start of data collection were selected from a total of 6 NHS study across the United Kingdom.

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

Patients with Crohn's disease, Colitis ulcerative

Estimated number of subjects

200
Study design details

Main study objective

The primary objective of this study is to describe the early real world use of vedolizumab in the treatment of UC and CD.

Outcomes

Primary outcome measure will assess the median time upon treatment with vedolizumab. The secondary outcome will assess effectiveness, safety, tolerability and patient characteristics upon treatment of vedolizumab. Previous treatment history of patients will also be evaluated.

Data analysis plan

Descriptive statistical analyses are planned to be reported due to the retrospective observational nature of the study. Kaplan-Meier curve will be used to report the primary outcome measure.
Documents
Study publications
https://pubmed.ncbi.nlm.nih.gov/30817598/