Study identification

EU PAS number

EUPAS35468

Study ID

37326

Official title and acronym

Post-authorization Safety Surveillance Program for Sarilumab using existing European Rheumatoid Arthritis Registries in Germany, Spain, Sweden and United Kingdom

DARWIN EU® study

No

Study countries

Germany
Spain
Sweden
United Kingdom

Study description

The research question and objectives of this study are to monitor the safety of sarilumab and evaluate the risk of selected outcomes of interest with long term use in patients with rheumatoid arthritis (RA) in real-world clinical practice, this safety study will be conducted in four European countries with the following selected outcomes of interest: serious infections, malignancies, major adverse cardiovascular events (MACE), gastro-intestinal (GI) perforations.
The primary objectives:
- To monitor long-term safety of sarilumab by estimating incidence rates of outcomes of interest among patients treated with sarilumab, including serious infections, malignancies, GI perforations and MACE in real-world clinical practice in each study country
- To estimate hazard ratios (HRs) of the outcomes of interest in the sarilumab cohort as compared to the biological disease-modifying anti-rheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKis) cohort in real-world clinical practice in each study country

The secondary objectives:
- To provide additional background information for the sarilumab and bDMARDs/JAKis cohorts by estimating incidence rates of the outcomes of interest in a cohort of patients who are exposed to conventional synthetic disease-modifying anti-rheumatic drug (csDMARDs) in real-world clinical practice in each study country, except Spain
- To conduct a meta-analysis to estimate the pooled HRs from the four registries (sarilumab cohort vs bDMARDs/JAKis cohort)

Study status

Ongoing
Research institutions and networks

Institutions

Sanofi
First published:
01/02/2024
Institution
RABBIT (Germany, Berlin), BSRBR (UK, Manchester), BIOBADASER (Spain, Madrid), ARTIS (Sweden, Stockholm)

Networks

RABBIT, ARTIS, BSRBR

Contact details

Trial Transparency Team

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
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)