Study identification

EU PAS number

EUPAS34845

Study ID

42431

Official title and acronym

Treatment patterns and outcomes of Crohn’s disease and ulcerative colitis patients initiated with biologic therapies in Denmark (IBDBIODK)

DARWIN EU® study

No

Study countries

Denmark

Study description

Inflammatory bowel disease (IBD) is a chronic, autoimmune-mediated, inflammatory disorder, manifested by inflammation and tissue damage of the gastro-intestinal tract. IBD comprises two main sub-types, known as Crohn’s disease (CD), which can affect the entire digestive system and Ulcerative Colitis (UC), which mainly affects the large intestine. While biologics for CD and UC have demonstrated efficacy in clinical trials, data on their real-life use and performance remains limited. The objectives of the study are to characterize patients with CD and UC who initiate biologic therapy, and to assess outcomes and comparative effectiveness of specific biologics for CD and UC separately in a real-world setting using Danish national health registry data between 2015 and 2018. The following biologic therapies are investigated: infliximab, adalimumab, vedolizumab, ustekinumab and golimumab. The primary study outcomes are: • Discontinuation of biologic therapy. • Switch from one biologic therapy to another. The secondary outcomes are: • All-cause hospital contacts • IBD-related acute hospital contacts • IBD-related surgery • Need for corticosteroid treatment • General practitioner visits • Change in Inflammatory biomarker levels

Study status

Ongoing
Research institutions and networks

Institutions

Center for Clinical Research and Prevention

Contact details

Janne Petersen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Cilag A/S
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable