Study identification

EU PAS number

EUPAS44885

Study ID

45899

Official title and acronym

An Observational Postauthorization Safety Study To Describe The Safety Of Ustekinumab and Other Biologic Treatments in a Cohort of Patients With Ulcerative Colitis or Crohn’s Disease Using Compulsory Swedish Nationwide Healthcare Registers and the Independent Swedish National Quality Register for Inflammatory Bowel Disease (SWIBREG) (Stelara UC/CD PASS (SWIBREG))

DARWIN EU® study

No

Study countries

Sweden

Study description

Observational study, all drugs are prescribed (and dispensed) or administered in hospital and hospitalizations or follow-up visits registered as a part of routine medical practice.
Primary objective: evaluate the long-term safety of ustekinumab (incidence of malignancies, infections (serious infections, opportunistic infections, and tuberculosis) and venous thromboembolic events), in patients treated with ustekinumab for Crohn's disease (CD) and Ulcerative Colitis (UC).
Secondary objective: compare long-term safety in CD and UC patients treated with ustekinumab and patients treated with other IBD (CD and UC) disease therapies, including TNF-alpha inhibiting (TNFi) agents or anti-integrins.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Ola Olen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Pharmaceutical
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)