Status: Planned First registered on: 30/08/2019
Last updated on: 02/09/2019
1. Study identification
EU PAS Register NumberEUPAS31199
Official titleEvaluation 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)
Study title acronymBIOGRIC
Study typeObservational study
Brief description of the studyRheumatoid 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsParis Pharmacoepidemiology Centre
Department/Research groupCentre de pharmaco-épidémiologie
Organisation/affiliationAssistance Publique - Hôpitaux de Paris
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Molto
First name Anna
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201901/01/2019
Start date of data collection31/12/2019
Start date of data analysis31/12/2019
Date of interim report, if expected
Date of final study report31/01/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyDGOS – PHRC-N100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Molto
First name Anna
Address line 1Rheumatology department – Cochin hospital
Address line 227 Rue du Faubourg Saint-Jacques 
Address line 3 
CityParis 
Postcode75014 
CountryFrance
Phone number (incl. country code)33158412619 
Alternative phone number 
Fax number (incl. country code) 
Email address anna.molto@aphp.fr
Public Enquiries
Title Dr 
Last name Molto 
First name Anna 
Address line 1Rheumatology department – Cochin hospital 
Address line 227 Rue du Faubourg Saint-Jacques 
Address line 3 
CityParis 
Postcode75014 
CountryFrance 
Phone number (incl. country code)33158412619 
Alternative phone number 
Fax number (incl. country code) 
Email address anna.molto@aphp.fr 
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