Study identification

EU PAS number

EUPAS31199

Study ID

44499

Official title and acronym

Evaluation of the risks of biologic drugs exposure during pregnancy in patients with rheumatic chronic inflammatory diseases: data from the French national healthcare data system (SNDS) (BIOGRIC)

DARWIN EU® study

No

Study countries

France

Study description

Rheumatoid arthritis (RA) psoriatic arthritis (PsoA) and Spondyloarthritis (SpA) are the most frequent rheumatic chronic inflammatory disease (RCID) in women of childbearing age, and can lead to permanent joint destruction and disability. Biologics, in particular TNF inhibitors (TNFi), have dramatically improved the outcome of these patients, nevertheless, an increased infectious risk related to these drugs has been reported. The main aim of this study is to compare the risks of a 'poor pregnancy outcome' in exposed vs not exposed to TNFi RCID patients. Secondary aims are: a) To describe the treatment of RA, SpA or PsoA during pregnancy regarding: • Non-steroidal-anti-inflammatory drugs and corticosteroids, • Conventional disease-modifying anti-rheumatic drugs (DMARDs), • Biologic DMARDs: TNFi and other biologics. b) To compare, in women with RA, SpA or PsoA exposed to TNFi vs unexposed women, the risks of maternal and perinatal infections, congenital malformations and gestational diabetes c) To evaluate the risk of above-described outcomes in pregnant patients exposed to other biologics during pregnancy in RA, SpA or PsoA women.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Anna Molto

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

French Ministry of Health
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable