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)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44499
• 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 institution and networks

Institutions

Assistance Publique - Hôpitaux de Paris (AP-HP)

France

Study timelines

Date when funding contract was signed

Planned: 01/01/2019

Actual: 01/01/2019

Study start date

Planned: 31/12/2019

Actual: 24/09/2019

Data analysis start date

Planned: 31/12/2019

Actual: 24/09/2019

Date of final study report

Planned: 31/12/2022

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