Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000543

EU PAS number

EUPAS1000000543

Study ID

1000000543

Official title and acronym

Association between previous biologic therapy exposure and incidence of life-threatening infections in patients with rheumatoid arthritis and psoriasis. A population-based cohort study.

DARWIN EU® study

No

Study countries

Spain

Study description

Since the advent of biologic agents targeting key proinflammatory pathways, the treatment of chronic inflammatory and autoimmune diseases has substantially changed.
Rheumatoid arthritis and psoriasis are two of the most common conditions for which these agents are administered.
Patients taking biologics are more prone to mild infections; however, since most trials conducted have been of short duration, long-term follow-up of these individuals is necessary.
Their association with serious infections has not yet been thoroughly analyzed.
In response to the need for further investigation into the long-term effects of biologic therapies, we propose a cohort study of patients with rheumatoid arthritis and/or psoriasis, comparing those exposed to biologic drugs with those who have not been exposed. We aim to analyze the association with potentially severe infections, including influenza, sepsis, pneumonia, and COVID-19.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Rosa Morros

Primary lead investigator
ORCID number:
0000-0001-6752-8748
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ciber INFEC (CENTRO DE INVESTIGACIÓN BIOMÉDICA EN RED. Enfermedades infecciosas): https://www.ciberinfec.es/en
Study protocol
Initial protocol

Biologics_Protocol_v4.0_clean_20250221.pdf

English (1022.97 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable